Evaluation of the second European and Developing Countries Clinical Trials Partnership Programme (EDCTP2) 2014-2016 : analysis of results from the public consultation : 2016.
Date: 2018-01-15
Institutions: Directorate-General for Research and Innovation
Subjects: EU financing arrangements, EU programme, clinical trial, developing countries, medicinal product, public consultation, report

Evaluation of the Second European 
and Developing Countries Clinical 
Trials Partnership Programme 
(EDCTP2) 2014-2016 

Analysis of results from the 

Public Consultation 

2016 

Prepared by Felix Sommer 

 
 
 
 
 
EUROPEAN  COMMISSION 

Dire ctorate-General for Research and Innovation 
Dire ctorate R TD-E — He alth  
Unit R TD E3— Fighting infectious diseases and advancing public health  

C ontact:Inmaculada Peñas Jiménez 

E-mail:  RTD-INFECTIOUS-DISEASES-PUBLIC-HEALTH@ec.europa.eu 

inm aculada.penas-jimenez@ec.europa.eu 
R TD-PUBLICATIONS@e c.europa.eu 

European  Commission 
B-1049 Brussels 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EUROPEAN C OMMISSION 

Evaluation of the Second European 
and Developing Countries Clinical 
Trials Partnership Programme 
(EDCTP2) 2014-2016 

Analysis of results from the 

Public Consultation 

2016 

Directorate-General for Research and Innovation 
Health  demographic change and wellbeing 

 
 
 
 
 
 
 
 
 
 
 
 
 
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Table of Contents  

1.  EXECUTIVE SUMMARY ......................................................................................... 11 
1.1.  Respondents’ Profile ..................................................................................... 13 
1.2.  Progress Towards EDC TP2’s Objectives ........................................................... 13 
1.3.  Governance and Management ........................................................................ 16 
1.4.  Respondents’ Overall Assessment and Recommendations ................................. 17 
1.5.  Advocacy and C ommunication........................................................................ 18 
INTRODUCTION .................................................................................................. 19 

2. 

2.1.  Background Information on the Initiative  ........................................................ 19 
2.2.  Purpose of the Analysis ................................................................................. 21 
2.3.  Scope of The Analysis ................................................................................... 22 

3.  METHODOLOGICAL  NOTE  REGARDING  THE  PRESENTATION  OF 

RESULTS ............................................................................................................. 22 
3.1.  Overview of the Questionnaire ....................................................................... 22 
3.2.  Methodology ................................................................................................ 23 
3.3.  Limitations ................................................................................................... 24 
4.  RESPONDENT PROFILE  ....................................................................................... 25 

4.1.  Agreement to Publication............................................................................... 25 
4.2.  Type And Location Of Organisations ............................................................... 26 
4.3.  Nature of Involvement with EDC TP ................................................................. 29 
5.  ADVOCACY AND COMMUNICATION ..................................................................... 30 

5.1.  Overall  Rating  of  C ommunication  Activities  &  Europe -Africa 

Relations 30 

5.2.  Relevance and Visibility ................................................................................. 31 
5.3.  Rating of Individual C ommunication Activities .................................................. 34 
5.4.  Advocacy  &  C ommunication  –  Results  Divided  by  C ategory  of 

Respondent ................................................................................................. 39 
6.  PROGRESS TOWA RDS EDCTP2’S OBJECTIVES  .................................................... 43 

6.1.  C apacity  Of  Sub-Saharan  African  C ountries  To  C onduct  C linical 

Trials 

44 

6.2.  C ooperation  Between  European  And  Sub-Saharan  African 

C ountries..................................................................................................... 46 

6.3.  New  Or  Improved  Medical  Interventions  For  HIV/Aids,  TB, 

Malaria & Other PRNDs.................................................................................. 46 
Integration Of National Programmes............................................................... 48 
6.4. 
6.5. 
International C ooperation With Other Public And Private Partners ...................... 49 
6.6.  C ooperation With Other Relevant European Union Initiatives  ............................. 50 
6.7.  Progress  Towards  Objectives  –  Results  Divided  by  C ategory  of 

Respondent ................................................................................................. 51 
7.  GOVE RNA NCE & MANAGEMENT ........................................................................... 54 

7.1.  Management And Execution Of The EDC TP2 Programme ................................... 55 
7.2.  Strategy And Processes For Setting EDCTP2's Funding Priorities  ........................ 56 

 
 
7.3.  Funding  To  Support  C linical  Trials  Research  In  Sub -Saharan 

Africa 

56 

7.4.  Funding  To Strengthen The  C apacities  Of  SAA  C ountries To 

C onduct C linical Trials ................................................................................... 57 

7.5.  Quality  And  Transparency  Of  EDC TP2's Proposal Evaluation And 

Selection Process.......................................................................................... 58 

7.6.  Effectiveness  Of  EDC TP2's  Proposal,  Submiss ion  And  Grant 

Management Tools ....................................................................................... 58 
7.7.  Prevention Of C onflicts Of Interest ................................................................. 59 
7.8. 
Implementation Of Previous Recommendations................................................ 60 
7.9.  Overview of Governance and Management Activities ........................................ 61 
7.10.  Governance  &  Management  –  Results  Divided  by  C ategory  of 

Respondent ................................................................................................. 63 

8.  RESPONDENTS’ 

OVERALL 

ASSESSMENT 

AND 

RECOMMENDATIONS  .......................................................................................... 66 
8.1.  Strengths .................................................................................................... 66 
8.2.  Weaknesses & Opportunities for Improvement................................................. 67 
8.3.  Recommendations about the future direction of EDC TP2 ................................... 68 
9.  CONCLUSIONS  .................................................................................................... 69 

10.  APPENDICES  ....................................................................................................... 76 
10.1.  Appendix A – Extended Methodological Note.................................................... 76 
10.2.  Appendix B – Survey Questionnaire ................................................................ 80 
10.3.  Appendix C  – Desk Review Documents ........................................................... 88 

6 

 
 
 
 
 
Table of Figures   

Figure 1 – Agreement to Publication ................................................................. 25 

Figure 2 – Type of Organisation ....................................................................... 27 

Figure 3 – Geographic Distribution of Responses by Region................................. 28 

Figure 4 – Nature of Involvement with EDC TP ................................................... 29 

Figure 5 – C ommunication Activities ................................................................. 30 

Figure 6 – Advocacy Activities ......................................................................... 31 

Figure 7 – Relevance & Visibility for Research C ommunity Worldwide................... 32 

Figure 8 – Relevance & Visibility for Health Researchers in SSA ........................... 32 

Figure 9 – Relevance & Visibility for Other Public Health Stakeholders in SSA ....... 33 

Figure 10 – Relevance & Visibility for Health Researchers in Europe ..................... 33 

Figure 11 – Website........................................................................................ 34 

Figure 12 – C all Announcements ...................................................................... 35 

Figure 13 – Applicant / Grantee Support ........................................................... 35 

Figure 14 – Stakeholder Meetings .................................................................... 36 

Figure 15 – EDC TP Forum ............................................................................... 36 

Figure 16 – Newsletters  .................................................................................. 37 

Figure 17 – Annual Reports ............................................................................. 37 

Figure 18 – C ombined Average Ratings of C ommunication Instruments................ 38 

Figure 19 – Ranking of Communication Instruments .......................................... 39 

Figure 20 – C ommunication Activities by Respondents' Type of Involvement... Error! 

Bookmark not defined. 

Figure 21 – Stakeholder Meetings by Respondents' Type of Involvement.............. 40 

Figure 22 – Applicant / Grantee Support by Respondents’ Type of Involvement .... 42 

Figure 23 – SSA C ountries’ C apacity to C onduct C linical Trials............................. 44 

Figure 24 – Funding Priorities Reflect Needs of SSA Countries  ............................. 45 

7 

 
 
 
 
Figure 25 – C ooperation between European and SSA countries  ........................... 46 

Figure 26 – New or Improved Medical Interventions........................................... 47 

Figure 27 – Guidelines for Existing Medical Interventions .................................... 47 

Figure 28 – International C ooperation with Public and Private Partners ................ 48 

Figure 29 – International C ooperation with Public and Private Partners ................ 49 

Figure 30 – C ooperation with Other Relevant EU Initiatives................................. 50 

Figure 31 – C apacity Strengthening for C Ts by Respondents' Type of Involvement 51 

Figure 32 – Europe – SAA C ooperation by Location of Respondents ..................... 52 

Figure 33 – Funding priorities reflect the needs of SSA countries ......................... 53 

Figure 34 – Overall Management & Execution .................................................... 55 

Figure 35 – Strategy & Processes for Setting EDC TP2’s Funding Priorities ............. 56 

Figure 36 – Funding  to Support C linical Trials Research in SSA............................ 57 

Figure 37 – Funding  to Support SSA C ountries’ C apacity to C onduct C linical Trials. 57 

Figure 38 – Quality & Transparency of Proposal Evaluation and Selection Process.. 58 

Figure 39 – Effectiveness of Proposal, Submission and Grant Management Tools... 59 

Figure 40 – C onflict of Interest Prevention Policies ............................................. 59 

Figure 41 – Implementation of Previous Recommendations................................. 60 

Figure 42 - C hanges Based on Recommendations from Previous Evaluations  ........ 61 

Figure 43 – Ranking of Governance and Management Activities ........................... 62 

Figure  44  –  Proposal  Evaluation  and  Selection  Process  by  Respondents'  Type  of 
Involvement........................................................................................... 64 

Figure 45 – Management and Execution by Respondents' Type of Involvement ..... 65 

Figure 46 – Key Strenghts............................................................................... 66 

Figure 47 – Weaknesses ................................................................................. 67 

Figure 48 – Progress towards EDC TP2’s Objectives ............................................ 73 

8 

 
 
 
 
List of Abbreviations  

AIDS  

ARV  

AU  

C T  

Acquired Immuno-Deficiency Syndrome 

Antiretroviral Treatment 

African Union 

C linical Trials 

DC C C    

Developing C ountries C oordinating C ommittee  

EAC   

EC   

East African C ommunity 

European C ommission 

EC C AS   

Economic C ommunity of C entral-African States 

EC OWAS  

Economic C ommunity of West African States 

EDC TP   

EDC TP1 

European and Developing C ountries C linical Trials Partnership 

First  Phase of EDC TP (2003 –  2013) 

EDC TP2 

Second Phase of EDC TP (2014 – 2024)   

EEIG  

European Economic Interest Group 

EU  

EP  

FDA  

FP7  

GA 

European Union 

European Parliament 

Food and Drug Administration 

EU 7th  Framework Program for Research and Tech. Development 

General Assembly  

GFATM  

Global Fund  to Fight  Aids, TB and Malaria (The Global Fund)   

GC LP  

GC P  

HIV  

IASG  

IEE  

Good C linical Laboratory Practice 

Good C linical Practice 

Human Immunodeficiency Virus 

Impact Assessment Steering Group 

Independent External Expert 

IGAD    

Intergovernmental Authority on Development 

IRB  

IPR  

MDG  

MEP  

MS  

MRC   

Institutional  Review Board 

Intellectual Property Right 

Millennium  Development Goal 

Member of the  European Parliament 

Member State of the  EU 

Medical Research C ouncil 

MTC T    

Mother to  C hild Transmission 

NC D 

Non-communicable Disease 

NEPAD   

New Partnership for Africa’s Development  

NID  

Neglected Infectious Disease 
9 

 
 
 
 
 
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NP  

NTD 

PB  

PDP  

National Programme 

Neglected Tropical Disease  

Partnership Board 

Product-Development Partnership  

PRNDs   

Poverty-related and Neglected Diseases  

PS 

PPP  

R&D  

RC T  

Participating State  

Public Private Partnership 

Research and Development 

Randomised C linical Trials 

SADC     

Southern African Development C ommunity  

SAC  

SDG 

SSA 

TB  

TFEU 

UN   

Scientific Advisory C ommittee  

Sustainable Development Goal  

Sub-Saharan Africa  

Tuberculosis 

Treaty on the Functioning  of the European Union 

 United Nations 

UNAIDS            Joint United  Nations Programme on HIV/Aids  

WHO                World Health Organization   
WHO/AFRO   WHO Regional Office for Africa 

10 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.  EXECUTIVE SUMMARY  

This  document  outlines  the  results  from  a  public  consultation  of  stakeholders of 
the  second  European  &  Developing  Countries  Clinical  Trials  Partnership 
(EDCTP2)  programme.  The  consultation,  which  took  place  between  29  June 
2016  and  15  November  2016,  invited  stakeholders  of  the  programme to provide 
their  data,  information  and  feedback  on  the  implementation  of  the  first  three 
years  (2014-2016)  of  EDCTP’s  second  phase  (2014-2024).  The  consultation 
was  carried  out  as  part  of  an  interim  evaluation  of  the  EDCTP2  programme, 
which  will  also  contribute  to  an  interim  evaluation  of  Horizon  2020,  the  EU’s 
eighth  framework  programme  for  research  and  innovation.  EDCTP2  is  a 
strategic  partnership  between  Europe  and  sub-Saharan  Africa  with  the  overall 
objective  “to  contribute  to  the  reduction  of  the  social  and  economic  burden  of 
poverty-related  diseases  in  developing  countries  by  accelerating  the  clinical 
development  of  effective,  safe,  accessible,  suitable  and  affordable  medical 
interventions  for  poverty-related  and  neglected diseases (PRNDs) in partnership 
with sub-Saharan Africa.”1 

In  order  to  assess  stakeholders’  perceptions about EDCTP2’s progress towards 
achieving  this  and  its  other  objectives,  an  electronic  survey  consisting  of  40 
questions  was  distributed  to  internal  and  external  stakeholders  of  the  EDCTP2 
programme.  The  European  Commission  published  the  survey  on  the  ‘Your 
Voice  in  Europe’  website  and  invited  over  700  stakeholders  to  participate. 
Invitations  were  sent  out  via  e-mail  and  stakeholders  were  again  asked  to 
complete  the  survey  at  the  eighth  EDCTP  Forum,  which  was  held  in  Lusaka, 
Zambia  from  6-9  November  2016.  Originally,  the  terms  of  reference  specified 
that  the  public  consultation  should  close  on  15  October  2016.  However,  due  to 
the  low  number  of  responses  that  was  received  by  this  point  the  consultation 
was  extended  to  15  November  2016  and  further  reminders  were  sent  out  to 
stakeholders. The consultation was open for a total of 18 weeks (4.5 months). It 
is  important  to  note  that  –  despite the significant efforts undertaken to distribute 
the  questionnaire  as  widely  as  possible  – only 67 responses were received. The 
low  number  of  responses  imposes  a  significant  limitation  on  the  analysis  of 
results below.  

1 Decision no. 556/2014/EU of the European Parliament and of the Council of 15 may 2014 on 
the participation of the Union in a second European and Developing Countries Clinical 
Trials Partnership programme (EDCTP2).  

11 

 
 
 
 
                                              
The  survey  questionnaire  that  was  distributed  electronically  asked  stakeholders 
to  complete  a  respondent  profile  as  well  as  to  provide  feedback  on  EDCTP2’s 
progress  towards  its  objectives,  its  governance  and  management,  and  its 
advocacy  and  communication  efforts.  In  the  survey’s  final  section,  respondents 
were  asked  to  provide  an  overall  assessment  of  EDCTP2  and  to  evaluate  it  in 
terms  of  key  strengths  and  weaknesses.  The  most  important  results  from  the 
analysis  of  each  of  the  survey’s  sections  are  summarised  below.  The  absolute 
number  of  responses  is  either  indicated  in  parentheses behind the percentage of 
respondents  who  selected  a  given  answer  or  next  to  the  number  indicating  the 
percentage.  

12 

 
 
 
 
1.1. 

Respondents’ Profile  

The  majority  of responses came from universities and research institutes (42%  - 
28),  followed  by  government  administrations  (19%  -  13),  non-governmental 
organisations  (15%  -  10),  private  non-profit  organisations  (15%  -  10),  of  which 
one  respondent  was  representing  the  European  Federation  of  Pharmaceutical 
Industries  and  Associations  (EFPIA),  other  for-profit  organisations  (4%  -  3), 
small  or  medium-sized  enterprises  (3%  -  2)  and  large  pharmaceutical 
companies  (2%  -  1).  A  total  of  76%  (51)  of  responses  came  from  survey 
participants  in  Europe.  22%  (15)  of  responses  came from survey participants in 
sub-Saharan Africa. 2% (1) of responses came from other regions. Compared to 
a  public  consultation  carried  out  in  2012  the  participation  rate  among  African 
stakeholders  was  slightly  lower.  In  2012,  58%  of  responses came from Europe, 
27% from Africa and 14% from other regions.2 

1.2. 

Progress Towards EDCTP2’s Objectives 

EDCTP2  was  created  to  strengthen  the  capacity  of  sub-Saharan  African 
countries  to  conduct  clinical  trials.  Overall,  84%  (56)  of  stakeholders expressed 
their  confidence  that  EDCTP2  is  progressing  towards  this  objective.  Only  6% 
(4)  of  respondents  believed  that  no  progress  towards  this  objective  is  being 
made.  However,  there  was  somewhat  less  certainty  that  EDCTP2’s  funding 
priorities  also  accurately  reflect  the  needs  of  sub-Saharan  African  countries. In 
total,  70  %  (47)  of  respondents  said  that  they  believe  that  EDCTP2’s  funding 
priorities  reflect  the  needs  of  sub-Saharan  African  countries.  However,  if  one 
only  takes  into  account  the  15  responses  that  came  from  respondents  in  sub-
Saharan Africa, this number  falls to 60% (9).  

EDCTP2  was  created  to  strengthen  cooperation  between  European  and  sub-
Saharan  African  countries.  Overall,  92%  (62)  of  respondents  believe  that 
EDCTP2  is  progressing  towards  this  objective  and  73  %  (49)  of  respondents 
rated  EDCTP2’s  efforts  in  this  area  as  either  “very good” or “good”. Only 4% 
(3)  of  stakeholders  see  no  progress  when  it comes to strengthening cooperation 
between European and Sub-Saharan  African countries.   

2 Assessment of the need for a renewed European and Developing Countries Clinical Trial 
Partnership  (EDCTP)  initiative  -  Analysis  of  Results  from  the  Public  Consultation 
(2012),page 11 

13 

 
 
 
                                              
EDCTP2  was  created  to  increase  the  number  of  new  or  improved  medical 
interventions  for  poverty-related and neglected diseases (PRNDs). Overall, 84% 
(56)  of  survey  participants  perceive  EDCTP2  to  be  making  progress  when  it 
comes  to  this  objective.  As  with  the  previous  objective  only  4%  (3)  of 
respondents were sceptical about EDCTP2’s performance in this  area.  

EDCTP2  was  created  to  contribute to  the  development  of  guidelines  for 
improving  or  extending  the  use  of  existing  medical  interventions.  Overall,  67% 
(45)  of  respondents  were  of  the  opinion  that  EDCTP2  is  progressing  towards 
this  objective.  Compared  to  the  first  three  objectives,  a  somewhat  lower 
proportion  of  survey  participants  sees  progress  when  it  comes  to  EDCTP2’s 
contribution to  the  development  of  guidelines  for  improving  or  extending  the 
use  of  existing  medical  interventions.  However,  this  discrepancy  can  be 
explained  by  the  significantly  higher  number  of  respondents  (27%  -  18)  who 
selected  “don’t  know”  as  their  response  to  this  question.  6%  (4)  of  survey 
participants  saw no progress towards this  particular  objective.     

EDCTP2  was  created  to  extend  international  cooperation  with  other  public  and 
private  partners  to  ensure  that  the  impact  of  all  research  is maximised and that 
possible  synergetic  effects  are  utilised.  Overall,  48%  (32)  of  stakeholders  see 
EDCTP2  as  making  progress  in  this  particular  area.  As  with  the  previous 
objective,  a  high  share  of  respondents  (42%  -  28)  selected “don’t know”, while 
10% (7) of survey participants  perceive EDCTP2 as failing  to achieve this goal.   

EDCTP2  was  created  to  better  coordinate,  align  and,  where  appropriate, 
integrate  relevant  national  programmes  to  increase  the  cost-effectiveness  of 
European  public  investments.  Overall,  39%  (26)  of  respondents  believe  that 
EDCTP2  is  making  progress  towards  this  objective.  To  some  extent  this  lower 
number  of  positive  responses  can  be  explained  by  the  circumstance that almost 
half  of  the  survey’s  participants  (46%  -  31)  selected  “don’t  know”  as  their 
response  to  this  question.  However,  there  is  also  a  higher  share of respondents 
(15%  -  10)  who  believe  EDCTP2  is  not  making  any  progress  towards  this 
objective.   

EDCTP2  was  created  to  increase  impact  due  to  effective  cooperation  with 
relevant  EU  initiatives,  including  its  development  assistance.  When  it  comes  to 
EDCTP2’s  success in progressing towards this goal, there was a very high level 
of  uncertainty  among  stakeholders,  with  63%  (42)  of  respondents  selecting 
“don’t  know”  as  their  answer.  22%  (15)  of  survey  participants  indicated  their 
agreement with the statement that EDCTP2 increases its impact due to effective 

14 

 
 
cooperation  with  relevant  EU  initiatives,  including  its  development  assistance, 
as opposed to 15% (10) of respondents who disagreed with the statement.  

In  summary,  stakeholders  seem  to  be  very  confident  that  EDCTP2  is  making 
progress towards its first four policy  objectives:   

1.  Strengthening  the  capacity  of  sub-Saharan  African  countries  to  conduct 

clinical  trials 

2.  Strengthening  cooperation  between  European  And  Sub-Saharan  African 

countries 

3.  Increasing  the  number  of  new  or  improved  medical  interventions  for 

poverty-related  diseases (PRDs), including  neglected ones 

4.  Contributing to 

the  development  of  guidelines 
extending  the use of existing  medical  interventions 

for 

improving  or 

When it comes to EDCTP2’s other policy  objectives  the results were mixed:   

5.  Extending 

international  cooperation  with  other  public  and  private 
partners  to  ensure  that  the  impact  of  all  research  is  maximised and that 
possible  synergetic effects are utilised 

6.  Coordinating,  aligning  and,  where  appropriate, 

integrating  relevant 
national  programmes  to  increase  the  cost-effectiveness  of  European 
public  investments 

7.  Increasing  impact  due  to  effective  cooperation  with  relevant  EU 

initiatives,  including  its development  assistance 

First,  stakeholders  were  generally  less  well  informed  with  42%  (28),  46%  (31) 
and  63%  (42)  respectively  selecting  “don’t  know”  in  response  to  questions that 
targeted  policy  objectives  5,  6  &  7.  This  in  itself  is  a  noteworthy  result,  as  it 
suggests  that  EDCTP2  is  not  communicating  adequately  about  its  activities  in 
these  fields.  Second,  in  all  three  areas,  there  was  a  higher  proportion  of 
respondents  sceptical  about  EDCT2’s  success  in  achieving  its objectives. Third, 
while  the  share of negative feedback increased compared to EDCT2’s first four 
objectives,  those  respondents  who  provided  positive  feedback  still  outnumbered 
those who gave negative feedback. Overall, due to the very high share of “don’t 
knows”  and the generally low number of responses, the results for the last three 
objectives  should  be  regarded  with  reservations.  Nevertheless,  they  allow  for 
the  conclusion  that  EDCTP2’s  progress  towards  its  policy  objectives  falls  into 
two  broad  categories:  High  confidence  among  stakeholders  that  progress  is 

15 

 
 
 
 
 
being made towards objectives 1, 2, 3 & 4, and a high degree of uncertainty and 
some scepticism  about  EDCTP2’s progress towards objectives  5, 6 & 7. 

1.3. 

Governance and Management   

A  majority  of  58%  (39)  of  respondents  rated EDCTP2’s management as either 
“very  good”  or  “good”  (positive),  as  opposed  to  11%  (8)  who  gave  a  rating  of 
“poor”  or  “very  poor”  (negative).  19%  (13)  of  survey  participants  rated 
EDCTP2’s  management  as  “fair”  (neutral).  Broken  down  into  individual 
governance  and  management  activities,  stakeholders’  opinions  fall  into  three 
distinct  groups.  

The  components  in  the  first  group  received  the  highest  share  of  positive 
feedback  and  either  no  or  only  very  few  negative  mentions  in  answers  to  the 
open  questions.  Overall,  survey  participants  expressed  confidence  in  these 
aspects of EDCTP2’s governance and management:   

1.  Funding  mechanisms  for clinical  trials  research 
2.  Funding  mechanisms  for capacity building  activities 

The  second  group  was  marked  by  somewhat  less  decidedly  positive  feedback 
and  the  qualitative  analysis  revealed  a  higher  share  of  criticism  in  the  open 
questions:   

3.  Setting  of funding  priorities 
4.  Conflict  of interest prevention   

The third group is composed of those components that received the lowest share 
of  positive  feedback  in  the  quantitative  analysis  and  the  highest  share  of 
negative  feedback in the qualitative  analysis:   

5.  Proposal submission  and grant management  tools 
6.  Proposal evaluation  and selection 

EDCTP2’s grant management and proposal submission processes were the most 
cited  weaknesses  in  respondents’  answers  to  open  questions  and  EDCTP2’s 
proposal  evaluation  and  selection  received  the  most  unfavourable  feedback  in 
the  quantitative  analysis  with  25%  (17)  of  respondents  rating  its  activities  in 
this area as either “poor” (13) or “very poor” (4). While there was still a relative 
majority  of  survey  participants  (42%  -  28)  that  assessed  EDCTP2’s  proposal 

16 

 
 
 
 
 
 
evaluation  and  selection  positively,  the  high  proportion  of  negative  feedback 
combined  with  the  elevated  number  of  respondents  who  complained  about  the 
inferior  quality  of  EDCTP2’s  grant  management  and  proposal  submission 
processes  in  the  open  questions  suggests  that  these  components  offer  the  most 
significant  opportunities  for improvement  for EDCTP2 in the future.   

1.4. 

Respondents’ Overall Assessment and 

Recommendations  

The  questionnaires’  final  section  asked  respondents  to  cite both EDCTP2’s key 
strengths  and  weaknesses.  Below  respondents’ answers are listed in decreasing 
order  of  the  frequency  with  which  they  were  mentioned,  i.e.  the  most  often 
cited strengths and weaknesses come first.  

Most Cited Strengths  

-  Capacity  building  activities  (e.g.  investments  in  skill-building  measures, 

an increased number  of fellowships)   

-  Broadening  of  EDCTP2’s  disease  scope  to  include  poverty-related  and 

neglected diseases (PRNDs) 

-  Facilitation  of  health  research  cooperation  across  sub-Saharan  Africa 

and between Europe and Africa 

-  Calls  for diagnostic  products 

Most Cited Weaknesses 

- 

Inferior  quality  of  EDCTP2’s  grant  management  and  proposal 
submission  processes  (including  criticisms  about  the  grant  submission 
process  being  too  slow  and  laborious,  frequent  delays  and  changes  of 
deadlines  and the quality  of reviews)  

-  Evaluation  process  is  insufficiently  transparent  (including  demands  for 
more  transparency  when  it  comes  to  the  selection  of  funding  priorities, 
the  process  through  which  funding  decisions  are  made and the reporting 
of conflicts  of interest)   

-  Lack of cooperation  with third  parties   
-  Late  publication  of  the  strategic  business  plan  and  the  annual  work 

plans,  making  it difficult  for applicants  to plan  ahead  

17 

 
 
 
 
 
 
   
 
 
1.5. 

Advocacy and Communication  

With  an  overall  positive  rating  of  75%  (50),  EDCTP2’s  communication 
activities  obtained  mostly  favourable  feedback.  However,  there  were two areas 
that  received  somewhat  less  unambiguously  positive  reviews  (i.e.  more  than 
25%  of  combined  negative  or  neutral  feedback). First, 35% (23) of respondents 
rated  EDCTP’s  Call  Announcements  either  neutrally  or  negatively,  which 
meant  that  they  received  the  highest  share  of  negative  responses  across  the 
seven  communication  instruments  surveyed.  Second,  26%  (18)  of  respondents 
rated  EDCTP2’s  Applicant  /  Grantee  Support  either  neutrally  or  negatively. 
Across  the  instruments  surveyed  Applicant  /  Grantee  Support  received  the 
second  highest  share  of negative feedback and  – adjusted for those respondents 
who  selected  “don’t  know”  –  it  received  the lowest share of positive responses 
across  all  communication  instruments.  Furthermore,  analysis  of  the  qualitative 
data  revealed  that  the  quality  of  the grant management and proposal submission 
processes  was  EDCTP2’s  most  frequently  cited  weakness.  These  two 
components  of  EDCTP2’s  communication  activities  offer  the  most  significant 
opportunities  for  improvement  in  the  future.  EDCTP’s  other  advocacy  and 
communication  activities,  especially  its  annual  reports,  newsletters  and  website 
received strongly  positive  feedback.  

respondents 

Due  to  the  low  number of responses it is problematic to draw conclusions about 
EDCTP2’s  overall  efficiency,  relevance,  coherence,  effectiveness  and  added 
value,  solely  based  on  this  analysis.  Nevertheless,  with  this  limitation  in  mind, 
it  can  be  said  that  a  majority  of  EDCTP2’s  stakeholders  perceives  the 
programme  to  be  efficient  in  the  sense  that  it  is  progressing  towards  its 
the 
objectives.  Similarly,  a  majority  of  survey 
programme  to  be  relevant  in  the  sense  that  it  meets  the  needs  of  sub-Saharan 
countries.  Likewise,  considering  the  largely  positive  feedback  on  most  of 
EDCTP2’s  governance  and management activities, it can be said that a majority 
of  stakeholders  believes  EDCTP2  to  be  working  effectively.  However,  with 
regard  to  stakeholder’s  perceptions  of  EDCTP2’s  coherence,  due  to the limited 
feedback  on  questions  focusing  on  this  aspect,  it  was  not  possible to come to a 
definitive  conclusion.  Finally  –  in  light  of  the  analysis’  significant  limitations  – 
it  is  important to note that a clearer picture of EDCTP2’s performance between 
2014  and  2016  could  be  gained  by  complementing  the  information  discussed 
here  with  additional  data.  In  the  absence  of  such  data  the  reservations 
mentioned  above should  be kept in mind.   

recognises 

18 

 
 
2.  INTRODUCTION  

2.1. 

Background Information on the Initiative  

The  European  &  Developing  Countries  Clinical  Trials  Partnership  (EDCTP) 
was  established  as  a  not-for  profit  organisation  in  2003  under  the  EU’s  sixth 
framework  programme  for  research.  EDCTP  was  created  in  response  to  the 
global  health  crisis  caused  by  the  three  major  poverty-related  diseases:  HIV, 
tuberculosis  and  malaria.  EDCTP1’s  principal  goal  was  to  accelerate  the 
improved  drugs,  vaccines,  microbicides  and 
development  of  new  and 
diagnostics  in  the treatment and prevention  of HIV, tuberculosis  and malaria.   

Its  unique  funding  approach  combined  supporting  clinical  research  and  capacity 
building  activities  in  so-called  Integrated  Projects,  which  were  conducted  by 
large  consortia  of  European  and  African  partners.  This  approach has facilitated 
the  alignment  and  coordination  of  European  national  research  programmes  and 
activities  and  has  fostered  African  leadership  in  clinical  research,  while  also 
improving  and  upgrading  research  infrastructure,  and  strengthening  the  ethics 
and  regulatory  environment  for  conducting  clinical  trials  in  sub-Saharan  Africa. 
EDCTP1  also  constituted  a  part  of  the  EU's  commitment  to  achieving  the 
Millennium  Development  Goals  (MDGs). 

In  its  approach  the  first  EDCTP  programme  (EDCTP1,  2003-2013) focused on 
clinical  trials  in  sub-Saharan  Africa.  Following  the  success  of  the  first 
programme,  the  EU  decided  in  2014  to  extend  its  commitment  to  this  strategic 
partnership  and  to  increase  its  contribution  from  EUR  200  million  for  the  first 
to  EUR  683  million  for  the  second  programme  (EDCTP2,  2014-2024).  The 
programme  receives  funding  as  part  of Societal Challenge Health, Demographic 
Change,  and  Wellbeing  of  Horizon  2020,  the  EU  Framework  Programme  for 
Research  and  Innovation.  The  first  EDCTP  programme  (EDCTP1,  2003-2013) 
was  created under Article 169 of the Treaty on the Functioning of the European 
Union  (TFEU).  This  article  has  since  been  re-numbered  as  Article  185  of  the 
Treaty on the Functioning  of the European  Union.   

Article  185  initiatives  are  joint  programmes  established  by  Member  States 
or/and  Associated  Countries 
financial 
participation  of  the  European  Union.  They  are  designed  to  meet  particular 
challenges in the research area and to complement EU research programmes, to 

('Participating  States')  with 

the 

19 

 
 
 
supplement  national  with  EU  funding,  and  to  create  economies  of  scales  and 
synergies  between  national  and  EU  research  programmes.  Article  185 
initiatives  are  funded  by  the  EU  under  the  Horizon  20203  regulation  and  in 
accordance with the provisions  of its Article  26 on 'Public-public  partnerships'.   

The  EDCTP2  programme  supports  the  clinical  development  and  testing  of  new 
or  improved  medical  interventions  for  HIV/AIDS,  tuberculosis,  malaria  and 
other  poverty-related  diseases,  including  neglected  ones.4  Its  general  objective 
is  “to  contribute  to  the  reduction  of  the  social  and economic burden of poverty- 
related  diseases  in  developing  countries,  in  particular  in  sub-Saharan  Africa,  by 
accelerating  the  clinical  development  of  effective,  safe,  accessible,  suitable  and 
affordable  medical  interventions5  for  PRNDs  in  partnership  with  sub-Saharan 
Africa.”6 

Since healthcare services in sub-Saharan Africa have to deal not only with HIV, 
tuberculosis  and  malaria,  but  with  many  other  poverty-related  and  neglected 
diseases  (PRNDs)  for  which  no  adequate  diagnostics,  drugs  or  vaccines  are 
available  and  since  co-morbidities  and  co-infections  are  the  rule  rather  than the 
exception,  the  scope  of  EDCTP2  was extended to include a list of 17 neglected 

No 

and 

Decision 

repealing 

3 Regulation (EU) 1291/2013 of the European Parliament and of the Council of 11 December 
2013  establishing  Horizon 2020 - the Framework Programme for Research and Innovation 
(2014-2020) 
1982/2006/EC  
http://ec.europa.eu/research/participants/data/ref/h2020/legal_basis/fp/h2020-eu-
establact_en.pdf 
4 In the EDCTP2 work plans 2014-2016, the diseases scope is described as follows: “In the 
EDCTP2  programme,  “poverty-related  diseases  (PRDs)”  include  HIV/AIDS,  malaria, 
tuberculosis and the following neglected infectious diseases (NIDs): dengue/severe dengue; 
rabies;  human  African 
(sleeping  sickness);  Leishmaniases; 
cysticercosis/taeniasis; dracunculiasis (guinea-worm disease); echinococcosise; foodborne 
trematodiases; lymphatic filariasis; onchocerciasis (river blindness); schistosomiasis; soil-
transmitted  helminthiases;  Buruli  ulcer;  leprosy  (Hansen  disease);  t rachoma;  yaws; 
diarrhoeal infections; lower respiratory infections; as well as emerging infectious diseases 
of particular relevance for Africa, such as Ebola and Yellow Fever.” 

trypanosomiasis 

5 In the framework of EDCTP2, ‘medical interventions’ encompass measures whose purpose is 
to improve or sustain health or alter the course of a disease, in particular prevention and 
treatment based on medicinal products such as drugs, microbicides or vaccines, including their 
delivery modality, follow up of treatment and prevention in the affected population as well as 
medical diagnostics to detect and monitor disease/health evolution. 
6 Decision no. 556/2014/EU of the European Parliament and of the Council of 15 may 2014 on 
the participation of the Union in a second European and Developing Countries Clinical 
Trials Partnership programme (EDCTP2).  

20 

 
 
 
 
                                              
infectious  diseases  (NIDs)  as  well  as  emerging  infectious  diseases of particular 
relevance for Africa,  such as Ebola and Yellow  Fever. 

2.2. 

Purpose of the Analysis 

The  objective  of  the  public  consultation  was  to  invite  the  views  and opinions of 
stakeholders,  experts  active  in  the  field,  and  the  wider  public  on  the 
implementation  of  the  EDCTP2  Programme  during  the  first  three  years  of 
operation  (2014-2016).  These  views  and  opinions  will  contribute  to  the  interim 
evaluation  of 
the  European 
the  EDCTP2  programme,  carried  out  by 
Commission  with the assistance of independent  experts. 

In  accordance  with  decision  556/2014/EU  of  the  European  Parliament  and  of 
the  Council  on  the  participation  of  the  EU  in  a  second  European  and 
Developing  Countries  Clinical  Trials  Partnership  Programme  (EDCTP2,  2014-
2024)  jointly  undertaken  by  several  Member  States,  the  European  Commission 
has  to  carry  out,  with  the  assistance  of  independent  experts,  an  interim 
evaluation  of  the  EDCTP2  programme  by  30  June  2017.  This  decision  further 
specifies  that  the  European  Commission  has to deliver a report on the EDCTP2 
interim  evaluation  to  the  European  Parliament  and  to  the  Council  by  31 
December  2017,  including  the  Commission's  conclusions  of  the  evaluation. 
Furthermore,  it  specifies  that  its  results  will  be  included  in  the  interim 
evaluation  of  Horizon  2020.  The  objective  of  the  interim  evaluation  is  to assess 
the  implementation  of  the  EDCTP2  programme  up  to  the  present  moment;  to 
judge  how 
evaluations  have  been 
implemented;  and  to  provide  an  outlook  on  what  can  be  expected  from 
EDCTP2 in the future. 

recommendations 

from  previous 

In  line  with  the  Better  Regulation  guidelines,  the  EDCTP2  programme  interim 
evaluation  is  based  on  a  consultation  strategy  that  includes  a  consultation  of 
external  stakeholders.  The  views  and  opinions  expressed  by  these  stakeholders 
will  contribute  to  the  interim  evaluation  of  the  EDCTP2  programme,  which  is 
carried  out  by  the  European  Commission  with  the  assistance  of  independent 
experts.  

The  public  consultation  was  opened  on  29  June  2016  with  a closure date on 15 
October  2016.  All  citizens  and  organisations  were  welcome  to  contribute. 
However,  contributions  from  stakeholders  and  experts  active  in  the  field  of 
clinical  trials  in developing  countries  were particularly  sought  after. 

21 

 
 
 
 
 
 
2.3. 

Scope of The Analysis  

The  scope  of  this  analysis  is  to  assess  the  results  of  the  EDCTP2  public 
consultation,  which  took  place  between  29  June  2016  and  15  November  2016. 
The  public  consultation  was  conducted  through  an  online  survey  using  the 
European  Commission’s  official  online  survey  management  tool,  EU  Survey 
(http://ec.europa.eu/research/consultations/edctp-2-2014-
2016/consultation_en.htm  ).  The  survey  went  online  on  29  June  2016  with 
closure date of 15 October 2016. Due to an insufficient number of responses the 
public  consultation’s  closure date was later postponed  to 15 November 2016.   

This  analysis  assesses the results of the public consultation, from which it draws 
conclusions,  taking  into  account  the  objectives  of  the  EDCTP2  programme  set 
out  in  the  Annex  I  to  the  decision  556/2014/EU,  and  covering  the  following 
elements:   

▪  The  efficiency  of  the  EDCTP2  programme  (including  aspects  such  as 

implementation,  governance and supervision); 

▪  The  relevance  and  appropriateness  of  the  EDCTP2  programme  in  line 

with decision  556/2014/EU; 

▪  The  coherence  with  other  EU  initiatives  and  actions  which  are 

thematically  related to the EDCTP2 programme;   

▪  The  effectiveness  of  the EDCTP2 programme and its contribution to the 
general  policy  objectives  of  the  EU,  and  in  particular  the  Horizon  2020 
objectives.   

3.  METHODOLOGICAL NOTE REGARDING THE PRESENTATION 

OF RESULTS  

3.1. 

Overview of the Questionnaire   

Stakeholders  were  alerted  to  the  consultation  process  by  online  publication  on 
the  'Your  Voice  in  Europe'  webpage.  In  addition,  e-mails  were  sent to relevant 
mailing  lists  held  by  DG  RTD,  the  EDCTP  Secretariat  and  other  EU  services, 
inviting  stakeholders  to participate.   

A questionnaire  was developed  to assess stakeholders' opinions  of the 
implementation  of the EDCTP2 programme  during  the first three years of 
operation  (2014-2016)  in  key areas. The questionnaire  was divided  into  five 

22 

 
 
 
 
 
 
 
sections and consisted  of 40 questions  regarding:   

1. Personal Information 
2. Advocacy and Communication 
3. Progress towards EDCTP2's Objectives   
4. Governance and Management 
5. Overall  Assessment and Recommendations 

The  first  section  asked  respondents  to  provide  their  personal  information. 
Respondents  were  asked  to  indicate  whether  or not they want  their contribution 
to  this  consultation  to  be  published.  They  were  also  given  the  option  of 
indicating  if  they  wanted  their  responses  to  the  questionnaire  to  be  published 
under  their  own  name  or  the  name  of  their  organisation.  In  sections  2-5 
respondents  were  asked  to  provide  their  opinions  on  the  implementation  of  the 
EDCTP2  programme  during  the  first  three  years  of  operation  (2014-2016).  An 
extended  methodological  note  that  gives  a  more  detailed  overview  of  the 
questionnaire  and  its  analysis  can  be  found  in  appendix  A.  The  questionnaire 
itself  can be found in appendix  B.   

3.2. 

Methodology 

The  methods  applied  for  the  analysis  of  results  from  the  public consultation are 
summarised  as follows:   

1.  Desk  review  of  already  existing  information to gain a good understanding of 
EDCTP2’s  governance  structure,  financial  organisation,  and  activities 
undertaken  since  2014.  The  resources  and  documents  used  for  the  desk 
review can be found in appendix  A.  

2.  An  electronic  survey  consisting  of  40  questions  was  distributed  to  internal 
and  external  stakeholders  of  EDCTP  as  well  as  the general public between 
29  June  2016  and  15  November  2016.  The  survey  questionnaire  was  only 
available  in  English.  In  addition  to  the  original  invitation  to  the  survey  that 
was  sent  out  on  29  June  2016,  several  reminders  were  sent  out  in  order to 
increase  the  response  rate  and  collect  as much information as possible. The 
survey questionnaire  can be found  in appendix  C.  

3.  To  investigate  the  opinions  of  EDCTP2’s  stakeholders  a  quantitative  and 
qualitative  analysis  of  the  survey  results  was  performed.  The  qualitative 

23 

 
 
 
 
analysis  was  conducted  through  key  word  searches  and  cross-referencing 
respondents’ answers to open questions.   

3.3. 

Limitations   

The  analysis’  main  limitation  was  the  relatively  small  number  of  responses  to 
the  questionnaire  that  were  gathered  between  29  June  2016  and  15  November 
2016.  Originally,  the  terms  of  reference  specified  that  the  public  consultation 
should  close  on  15  October  2016.  However,  since  only  47  respondents  had 
answered  the  questionnaire  at  this  point,  the  public  consultation  was  extended 
to  15  November  2016.  When  the  public  consultation closed, 67 respondents had 
completed  the  survey.  A  similar  public  consultation  that  was  conducted  in 2012 
to assess the need for a renewed EDCTP initiative gathered 235 responses to its 
questionnaire7.  Nevertheless,  a  sufficient  number  of responses  were received to 
complete  a  qualitative  and  quantitative  analysis  of  the  results  from  the  public 
consultation.  One  factor  that  might  be  to  blame  for  the  rather  low  rate  of 
participation  is  that  the  survey  questionnaire  was  only  made  available  in 
English.  Considering  EDCTP2  is  active  in  a  number  of  French-speaking 
countries  in  Africa,  future  public  consultations  should  aim  to  make  survey 
questionnaires  available  in  both  English  and  French  in  order  to  increase 
participation.   

A  further  limitation  was  the  relatively  small  number of responses received from 
participants  in  sub-Saharan  Africa.  Only  22%  of  responses received were from 
Africa,  with  the  overwhelming  majority  (76%)  of  responses  coming  from 
Europe.  In  order  to  gain  a  more  balanced  view,  future  public  consultations 
from 
should 
participating  states in sub-Saharan Africa. 

increase  efforts  aimed  at 

recruiting  survey 

respondents 

7 Assessment of the need for a renewed European and Developing Countries Clinical Trials 
Partnership (EDCTP) inititative – Analysis of Results from the Public Consultation – July 
2012, page 7 

24 

 
 
 
 
 
 
                                              
4.  RESPONDENT PROFILE  

At  the  beginning  of  the  questionnaire,  respondents  were  asked  a  series  of 
personal  questions.  They  were  asked  for  their  name,  e-mail  address,  the  name 
and  type  of  organisation  that  they  worked  for,  as  well  as  if  they  agreed  to  the 
publication  of  their  responses  to  the  questionnaire.    They  were  also  asked  to 
provide  information  on  where  their  organisation  was  based,  their  nationality and 
the nature of their involvement  with the EDCTP2 programme.   

4.1. 

 Agreement to Publication  

A  majority  of  respondents  (91%)  agreed  to  the publication of their responses to 
the  questionnaire.  The  majority  of  respondents  (55%)  wants  their  responses  to 
be  published  under  their  own  name,  the  name  of  their  organisation,  or  both. 
36%  of  respondents  want  their  contribution  to  be  published  anonymously.  9  % 
of respondents  did  not agree to the publication  of their contribution. 

Agreement to Publication 

I do not want my contribution to be published

9% 

I want my contribution to be published anonymously

36% 

I want my contribution to be published under the name
of my organisation

I want my contribution to be published under my name

22% 

27% 

I want my contribution to be published under my name
and the name of my organisation

6% 

0%

5% 10% 15% 20% 25% 30% 35% 40%

Figure 1 – Agreement to Publication  

25 

 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.2. 

Type And Location Of Organisations  

As  part  of  the  respondent  profile,  EDCTP2  stakeholders  were  asked  to  supply 
the  name  of  the  organisation  they  worked  for  and  the  country  where  the 
organisation  was primarily  based.  

Respondents  were  also  asked  to  define  their  organisation  in  terms  of  the 
following  categories:   

1.  University  / research institute   
2.  Government  Administration   
3.  Non-governmental  organisation   
4.  Large pharmaceutical  company   
5.  Small  or medium-sized  enterprise (SME8)   
6.  Other for-profit  organisation   
7.  Private non-profit  organisation 

Type of Organisation 

by 

government 

The  majority  of  responses  came from universities and research institutes (42%), 
followed 
non-governmental 
administrations 
organisations  (15%),  private  non-profit  organisations  (15%),  other  for-profit 
organisations 
large 
pharmaceutical  companies  (2%).  

(4%),  small  or  medium-sized  enterprises  (3%)  and 

(19%), 

8 SME - defined by the European Commission as follows: annual turnover of ≤ € 50 m; and 

staff of ≤ 250 

26 

 
 
 
 
 
 
 
 
 
 
 
                                              
Type Of Organisation 

University / 
Research 
Institute 
42% 

Government 
Administration 
19% 

Non-
Governmental 
Organisation 
15% 

Large 
Pharmaceutical 
Company 
2% 

Small or 
Medium-sized 
Enterprise 
3% 

Private Non-
Profit 
Organisation 
15% 

Other For-
Profit 
Organisation 
(i.e.. 
consultancies) 
4% 

Figure 2 – Type of Organisation  

Geographic Distribution  of Responses 

Respondents were asked about where their organisations are based and to select 
a  country  from  a  dropdown  menu. The majority of responses (67%) came from 
organisations  that  are  based  within  the  European  Union.  Another  9  %  of 
organisations  that  respondents  are  affiliated  with  are  based  in  Europe,  but 
outside  the  EU.  These  organisations  are  based  in  Norway,  Switzerland  and  the 
Holy  See.  Approximately,  a 
for 
organisations  that  based  in  Africa.  Of  these,  all  are  located  in  Sub-Saharan 
Africa.  A  small  number  of  responses  (2%)  came  from  outside  Europe  and 
Africa.  

(22%)  worked 

respondents 

fifth  of 

27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Geographic Distribution  
of Responses by Region 

Outside 
Europe / 
Africa 
2% 

Africa 
22% 

Europe (Non-
EU)  
9% 

European 
Union  
67% 

Figure 3 – Geographic Distribution of Responses by Region  

The  European  countries  participating  in  EDCTP  as  members  of  the  EDCTP 
Association  are:  Austria,  Denmark,  Finland,  France,  Germany,  Ireland,  Italy, 
Luxembourg,  Netherlands,  Norway,  Portugal,  Spain,  Sweden,  UK.  The  African 
countries  participating  in  EDCTP  as  members  of  the  EDCTP  Association  are: 
Burkina  Faso,  Cameroon,  Congo,  Gabon,  The  Gambia,  Ghana,  Mali, 
Mozambique,  Niger,  Senegal,  South  Africa,  Tanzania,  Uganda  and  Zambia. 
Responses  were  received  from  all  European  participating  states  except  for 
Austria,  Ireland  and  Luxembourg.  Responses  were  received  from  all  African 
participating  states  except  for  Burkina  Faso,  Congo,  Gambia,  Mali,  Niger, 
Senegal  and Uganda. Most responses from Europe came from Italy, France and 
the  United  Kingdom.  Most  responses  from  Africa  came  from  Kenya,  Nigeria 
and  Tanzania.  Compared  to  a  public  consultation  carried  out  in  2012  to  assess 
the  need  for  a  renewed  European  and  Developing  Countries  Clinical  Trials 
Partnership  initiative,  the  participation  rate  among  African  stakeholders  was 
slightly  lower.  In  2012,  58%  of  responses  came from Europe, 27% from Africa 
and 14% from other regions. 

28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.3. 

 Nature of Involvement with EDCTP 

Respondents  were  asked  to  classify  the  nature  of  their  involvement  with 
EDCTP according to the following  categories:   

Nature of Involvement with EDCTP 

I/my organisation has been funded by EDCTP1
and/or EDCTP2

44% 

I/my organisation has applied for funding from
EDCTP1 and/or EDCTP2

7% 

I am a member of the EDCTP General Assembly

16% 

I am a member of the EDCTP Scientific Advisory
Committee

1% 

Other type of involvement

17% 

No involvement

15% 

Figure 4 – Nature of Involvement with EDCTP 

Most  respondents  (75%)  are  directly  involved with the EDCTP2 programme. A 
large  group  of  respondents  (44%)  have  been  funded  by  EDCTP2  either 
personally  or  through  their  organisations.  Another  7%  have  applied  for  funding 
from  EDCTP2. 17% of respondents are either members of the EDCTP General 
Assembly  or  the  EDCTP  Scientific  Advisory  Committee.  Among  those  who 
classified  the  nature  of  their  involvement  with  EDCTP2  as  “other  type  of 
involvement,”  there  was  a  wide  variety  of  responses,  with  respondents  giving 
descriptions  of  their  involvement  with  EDCTP2  such  as  “co-funding  of 
projects”  or  “coordination  of  policy  interactions  with  private  sector  partners.” 
15% of respondents  had no prior  direct involvement  with EDCTP1 or EDCTP2.  

29 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.  ADVOCACY AND COMMUNICATION  

The  second  section  of  the  questionnaire  focused  on  EDCTP2’s  advocacy  and 
communication  activities.  This  section  consisted  of 
three  parts.  First, 
respondents  were  asked  about  the overall quality of EDCTP2’s communications 
activities  and  their  contribution  to  strengthening  the  relationship  between 
Europe  and sub-Saharan Africa. Second, respondents were asked four questions 
about  EDCTP2’s  relevance  and  visibility  for  different  stakeholder  groups  and 
regions.  Third,  respondents  were  asked 
individually  rate  EDCTP2’s 
communication  activities,  ranging  from  its  website  to  its  newsletters  and  annual 
reports.  For  the  first  and  second  part  of  this section, participants were asked to 
agree  or  disagree  with  a  series  of  statements  about  the  quality  of  EDCTP2’s 
communication  efforts.  For  each  of  the  statements,  participants  also  had  the 
option  to select “don’t know.” 

to 

5.1. 

Overall Rating of Communication Activities  & 

Europe-Africa Relations  

large  majority  of  survey  respondents  (75%)  agrees  that  EDCTP2’s 

A 
communication  activities  are relevant and of good quality.     

Overall, EDCTP2's communication 
activities are relevant and of good quality 

75% 

10% 

15% 

80% 

70% 

60% 

50% 

40% 

30% 

20% 

10% 

0% 

Agree 

Disagree 

Don't  know 

Figure 5 – Communication Activities  

30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The same holds true for the impact of EDCTP2’s  advocacy activities on Europe 
–  sub-Saharan  Africa  relations.  A  large  majority  of  73%  agrees  that  these 
activities  contributed  to  expand  and  strengthen  relationships  between  countries 
in Europe and sub-Saharan Africa.  

EDCTP2's advocacy activities contributed 
to expand and strengthen relationships 
between countries in sub -Saharan Africa 
and in Europe. 

73% 

9% 

18% 

Agree 

Disagree 

Don't  know 

80% 

70% 

60% 

50% 

40% 

30% 

20% 

10% 

0% 

Figure 6 – Advocacy Activities  

5.2. 

 Relevance and Visibility   

As  part  of  the  evaluation  of  EDCTP2’s advocacy and communication activities, 
participants  were  asked 
to  answer  four  questions  aimed  at  measuring 
perceptions  of  the  relevance  and  visibility  of      EDCTP2’s  work.  As  with  the 
pervious  questions,  respondents  were  asked  to  indicate  their  agreement  or 
disagreement  with a series of statements. A large majority of participants (75%) 
agreed  that  the  EDCTP2  programme  is  a  relevant  and  visible  initiative  for  the 
global  health  research  community  worldwide.  12%  of  respondents  disagreed 
with this  statement, while  13% selected “don’t  know” as their answer. 

31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The EDCTP2 programme is a relevant and 
visible initiative for the global health 
research community worldwide. 

75% 

12% 

13% 

Agree 

Disagree 

Don't  know 

80% 

70% 

60% 

50% 

40% 

30% 

20% 

10% 

0% 

Figure 7 – Relevance & Visibility for Research Community Worldwide 

A  similarly  high  level  of  agreement  (79%)  was  found  when  participants  were 
asked  to  indicate  whether  or  not  they  perceive  EDCTP2  to  be  a  relevant  and 
visible  initiative  for health researchers in sub-Saharan Africa.  

The EDCTP2 programme is a relevant and 
visible initiative for health researchers in  
sub-Sahran Africa. 

79% 

6% 

15% 

Agree 

Disagree 

Don't  know 

80% 

70% 

60% 

50% 

40% 

30% 

20% 

10% 

0% 

Figure 8 – Relevance & Visibility for Health Researchers in SSA 

When  the  same  question  was  asked  for  other  public health stakeholders in sub-
Saharan  Africa,  there  was  less  agreement  (51%)  and  significantly  more 

32 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
respondents (31%) selected “don’t know” as their response to the question. This 
might  be  due  to  fact  that  “other  public  health  stakeholders”  was  not  precisely 
enough  defined.  

The EDCTP2 programme is a relevant 
and visible initiative for other public 
health stakeholders in sub-
Saharan Africa. 

51% 

80% 

60% 

40% 

20% 

0% 

18% 

31% 

Agree 

Disagree 

Don't  know 

Figure 9 – Relevance & Visibility for Other Public Health Stakeholders in SSA 

The  last  question  in  this  section  assessed  perceptions  about  the  visibility  and 
relevance  of  EDCTP2  for  health  researchers  in  Europe.  This  question  yielded 
similar  responses  as  the  one  for  health researchers in sub-Saharan Africa. 73% 
of  respondents  agreed  that  EDCTP  is  a  relevant  and  visible  initiative for health 
researchers in Europe.  

The EDCTP2 programme is a relevant 
and visible initiative for health 
researchers in Europe. 

73% 

10% 

16% 

80% 
70% 
60% 
50% 
40% 

30% 

20% 
10% 
0% 

Agree 

Disagree 

Don't  know 

Figure 10 – Relevance & Visibility for Health Researchers in Europe  

33 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.3. 

Rating of Individual Communication Activities   

In  this  final  part  of  the  advocacy  and  communication section, respondents were 
asked  to  individually  rate  the  different  instruments  through  which  EDCTP2 
researchers,  policymakers  and  other 
interacts  and  communicates  with 
stakeholders.  Participants  were  specifically  asked  about 
following 
instruments:   

the 

1.  The EDCTP2 website 
2.  Call  announcements   
3.  Applicant  / Grantee Support   
4.  Stakeholder  Meetings   
5.  The EDCTP Forum  
6.  Newsletters  
7.  Annual  Reports  

Website 

EDCTP2’s  website  received,  combined,  66%  favourable  responses,  the  third 
highest  rating  after  newsletters  and  annual  reports.  19%  respondents  gave  the 
website  a  neutral  rating  and  only  5%  rated  the  Website  as  “poor”  or  “very 
poor.”  

In your opinion, how would you rate the quality of 
EDCTP2's different communication activities? 
 Website 

60%

50%

40%

30%

20%

10%

0%

45% 

21% 

19% 

very good

good

fair

poor

very poor

don't know

4% 

1% 

9% 

Figure 11 – Website  

34 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Call Announcements 

EDCTP2’s  call  announcements  during  its  first three years of operation received 
mostly  positive  feedback.  61%  of  participants  rated  its  call  announcements  as 
either  “very  good” or “good.” However, with 10% of respondents rating the call 
announcements  “poor”  or  “very  poor”,  they  received  twice  as  many  negative 
responses  as  the  EDCTP2 website. Out of all seven communication instruments 
that  participants  were  asked  to  rate,  call  announcements  received  the  highest 
proportion  of  negative  feedback,  which  seems  to  suggest  that  there  is room for 
improvement  in this  area.   

In your opinion, how would you rate the quality of 
EDCTP2's different communication activities? 
 Call Announcements 

60%

40%

20%

0%

37% 

24% 

25% 

very good

good

fair

poor

very poor

don't know

7% 

3% 

3% 

Figure 12 – Call Announcements 

   Applicant / Grantee Support 

EDCTP2’s applicant  and grantee support received 55% favourable  responses, 
19% neutral  responses and 7% unfavourable  responses. 18% of respondents 
were not familiar  with EDCTP2’s support  mechanisms  for applicants  and 
grantees and selected “don’t  know” as their response.  

In your opinion, how would you rate the quality of 
EDCTP2's different communication activities?  
Applicant/Grantee support 

60%

40%

20%

0%

33% 

22% 

19% 

7% 

0% 

18% 

very good

good

fair

poor

very poor

don't know

35 

Figure 13 – Applicant / Grantee Support  

 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
Stakeholder Meetings   

A  relatively  high  proportion  of  respondents  (40%)  selected  “don’t know”, when 
asked  to  rate  the  quality  of  EDCTP2’s  stakeholder  meetings,  which  seems  to 
suggest  that  many  of  the  stakeholders  who  participated  in  the  survey  have  not 
had  the opportunity to attend EDCTP stakeholder meetings in the past. Of those 
who  have  attended  these meetings, 38% gave them a favourable review, 15% a 
neutral review and 6% a negative review.   

In your opinion, how would you rate the quality of 
EDCTP2's different communication activities?  
Stakeholder Meetings 

60%

50%

40%

30%

20%

10%

0%

40% 

19% 

19% 

15% 

6% 

0% 

very good

good

fair

poor

very poor

don't know

Figure 14 – Stakeholder Meetings  

The EDCTP Forum 

the  EDCTP  forum,  a  relatively 

Compared  to  stakeholder  meetings,  respondents  were  somewhat  more  familiar 
with 
large  conference  on  HIV/AIDS, 
tuberculosis,  malaria  and  other  neglected  infectious  diseases  prevalent  in 
Africa,  which  takes  place  every  two  years.  The  EDCTP  forum  received  a 
combined  57%  favourable  responses  and  only  4%  of  participants  provided 
negative  feedback.  

In your opinion, how would you rate the quality 
of EDCTP2's different communication activities?  
The EDCTP Forum 

60%

40%

20%

0%

24% 

33% 

12% 

4% 

0% 

27% 

very good

good

fair

poor

very poor

don't know

Figure 15 – EDCTP Forum 

36 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Newsletters 

EDCTP2’s  newsletters  and  annual  reports  received  the  highest  number  of 
favourable  responses:  72%  of  respondents  rated  the  newsletters  and  annual 
reports as either “very good” or “good.”   

In your opinion, how would you rate the quality of 
EDCTP2's different communication activities?  
Newsletters 

57% 

15% 

7% 

4% 

0% 

16% 

very good

good

fair

poor

very poor

don't know

60%

50%

40%

30%

20%

10%

0%

Figure 16 – Newsletters 

Annual Reports 

EDCTP2’s  annual  reports  received  the  highest  proportion  of  very  positive 
feedback,  with  30%  of  participants  rating  them  as  “very  good.”  The  annual 
reports  also  received  the  lowest  number  of  negative  responses with only 3% of 
respondents rating  them as “poor.”  

In your opinion, how would you rate the quality of 
EDCTP2's different communication activities?  
Annual Reports 

42% 

30% 

50%

40%

30%

20%

10%

0%

12% 

13% 

3% 

0% 

very good

good

fair

poor

very poor

don't know

Figure 17 – Annual Reports 

37 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Combined 
Communication Instruments 

Average 

Ratings 

of 

EDCTP2’s 

Overall,  EDCTP2’s  different  communication  instruments  received  favourable 
feedback.  On  average,  across  the  seven  different  instruments,  22%  of 
respondents  gave  a  rating  of  “very  good”  and  38%  of  respondents  a  rating  of 
“good”.  16%  rated  EDCTP2’s  different  communication  instruments  as  “fair” 
and  only  5%  and  1%  rated  them  as  “poor”  or  “very  poor”,  respectively. 
revealed 
rate 
However,  asking 
differences in  how they are perceived.  

respondents 

instruments 

individually 

to 

Combined Average Ratings of EDCTP2's 
Communication Instruments  

38% 

22% 

50%

45%

40%

35%

30%

25%

20%

15%

10%

5%

0%

16% 

18% 

5% 

1% 

very good

good

fair

poor

very poor

don't know

Figure 18 – Combined Average Ratings of Communication Instruments  

The following  figure  ranks EDCTP2’s different communication  instruments  by 
the proportion  of positive  feedback they received. For the purposes of this 
analysis,  “very good” and “good”  responses were grouped  together as “positive 
feedback”. “Fair”  responses constitute  “neutral  feedback”. “Poor” and “very 
poor” responses were combined  to form the category “negative  feedback.” 

38 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ranking of Communication Instruments  

Annual Reports

Newsletters

Website

Call Announcements

EDCTP Forum

Applicant / Grantee Support

72% 

72% 

66% 

61% 

57% 

55% 

12% 

3% 

7% 

4% 

19% 

5% 

25% 

10% 

12% 

4% 

19% 

7% 

Stakeholder Meetings

38% 

15% 

6% 

0%

10%

20%

30%

40%

50%

60%

70%

80%

90% 100%

Positive

Neutral

Negative

Figure 19 – Ranking of Communication Instruments  

5.4. 

Advocacy & Communication – Results Divided by 

Category of Respondent 

The largest group of survey participants were stakeholders that have either been 
funded  by  EDCTP1  or  EDCTP2  in  the  past  or  have  applied  for  funding  from 
EDCTP1  or EDCTP2. These stakeholders form the category “funded or applied 
for  funding”.  The  second  largest  group  of  respondents  described  some  other 
type  of  involvement  with  EDCTP1  or  EDCTP2.  All  of  these respondents were 
grouped  together  to  form  the  category  “other  type  of  involvement”.  The  third 
largest  group  were  members  of  the  EDCTP  General  Assembly,  followed  by 
respondents  who  had  no  prior  direct  involvement  with  EDCTP1  or  EDCTP2, 
which  were  classified  as  “no  involvement”.  Finally,  among  the  stakeholders 
was  one  respondent  from  EDCTP2’s  Scientific  Advisory  Committee,  classified 
as “member of the SAC.”  
A  number  of  questions  was  selected  for  a  more  detailed  analysis  by 
respondents’  type  of  involvement  in  order  to  examine  whether  “type  of 
involvement”  had  a  significant  effect  on  how  respondents  replied  to  the 

39 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
questionnaire  and  to  describe  any  patterns  or  biases  if  found.  The  questions 
were  taken  from  the  following  sections:  advocacy  and  communication, progress 
towards  EDCTP2’s  objectives  and  governance  and management. The questions 
that were analysed along these lines were selected for a number of criteria (e.g. 
importance,  large share of respondents replied  “don’t  know”,  suspicion  of bias).   

Rating of Communication Activities by 
Respondents' Type of Involvement 

0% 5% 10% 15% 20% 25% 30% 35%

33% 

Funded or Applied for Funding

4% 

7% 

Member of the General Assembly

3% 

0% 

Other Type of Involvement

0% 

3% 

15% 

16% 

No Involvement

1% 

4% 

10% 

Member of the SAC

1% 

0% 
0% 

Positive

Negative

Don't know

Figure 20 – Communication Activities by Respondents' Type of Involvement  

In  absolute  numbers  survey  participants  belonging  to  the  category  “funded  or 
applied  for  funding”  tended  to  provide  most  of  the  negative  feedback  for  this 
question.  However,  adjusting  for  the  groups’  different  sizes  reveals  that  the 
members of the General Assembly were the most critical group when it came to 

40 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the  assessment  of  the  overall  quality  of  EDCTP2’s  communication  and 
advocacy  activities.    Nevertheless,  this  is  also  due  to  the  fact  that  respondents 
from  this  group  were  the  most  well-informed  with  not  a  single  participant 
selecting  “don’t  know”  for  this  particular  question.  These  trends  are  the  same 
for  the  second  question  that  was  analysed  by respondents’ type of involvement, 
when  survey  participants  were  asked  to  rate  EDCTP2’s  stakeholder  meetings. 
Again,  members  of  the  General  Assembly  were  the  most  knowledgeable  and 
accounted for a higher share of the negative  feedback.  

Rating of Stakeholder Meetings by 
Respondents' Type of Involvement 

0% 5% 10% 15% 20% 25% 30%

Funded or Applied for Funding

6% 

3% 

Member of the General
Assembly

1% 
2% 
1% 

12% 

12% 

24% 

Other Type of Involvement

No Involvement

Member of the SAC

0% 

7% 

6% 

6% 

4% 

1% 
1% 

9% 

1% 

0% 
0% 
0% 

Positive

Neutral

Negative

Don't know

Figure  21  –  Stakeholder  Meetings  by  Respondents'  Type  of 
Involvement 

41 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Rating of Applicant / Grantee Support by 
Respondents' Type of Involvement 

0%

5% 10% 15% 20% 25% 30%

Funded or Applied for Funding

Member of the General Assembly

Other Type of Involvement

No Involvement

27% 

7% 

4% 

6% 

1% 

0% 

9% 

7% 

12% 

4% 

1% 
1% 

6% 
6% 

1% 

3% 

Member of the SAC

1% 

0% 
0% 
0% 

Positive

Neutral

Negative

Don't know

Figure 20 – Applicant / Grantee Support by Respondents’ Type of Involvement  

Underscoring  the  reliability  of  the  results  this  trend  was  reversed  when  survey 
participants  were  asked  to  rate  EDCTP2’s  Applicant  /  Grantee  Support  –  a 
question  that  was  selected  because  it  received  both  the  second lowest share of 
positive  feedback  and  second  highest  share  of  negative  feedback  in  the 
advocacy  and  communication  section.  Adjusting  for  group  size,  members of the 
General  Assembly  were  significantly  less  well-informed  and  less  critical, 
especially  when  compared  to  respondents  belonging  to  the  category  “funded  or 
applied  for  funding.”  This  result  was  to  be  expected  considering  that  Members 
of  the  General  Assembly  are  usually  not  applicants  or  grantees and thus do not 
require  applicant  /  grantee  support.  Unsurprisingly,  those  stakeholders  that  rely 
on  this  support  (those  belonging  to  the  category  “funded  or  applied  for 
funding.”)  tended  to  be  the  ones  who  were both the most familiar and the most 
critical  of  this  component  of  EDCTP2’s  communication  activities  –  a  finding 
that underscores the robustness of the results.   

42 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.  Progress Towards EDCTP2’s Objectives  

The  overall  objective  of  the  second  programme  of  the  European  &  Developing 
Countries  Clinical  Trials  Partnership  (“the  EDCTP2  programme”)  is  to 
contribute  to  the  reduction  of  the social and economic burden of poverty-related 
diseases  (PRDs)  in  developing  countries,  in  particular in sub-Saharan Africa, by 
accelerating  the  clinical  development  of  effective,  safe,  accessible,  suitable  and 
affordable  medical  interventions  for  PRDs  in  partnership  with  sub-Saharan 
Africa.9 

More  specifically, 
achieving  the following  objectives:10 

the  EDCTP2  programme  should  contribute 

towards 

1.  Strengthening  the  capacity  of  sub-Saharan  African  countries  to  conduct 
clinical  trials  in  compliance  with  fundamental  ethical  principles  and 
relevant national,  EU and international  legislation.   

2.  Strengthening  cooperation  between  European  and  Sub-Saharan  African 

countries. 

3.  Increase  the  number  of  new  or  improved  medical  interventions  for 

poverty-related  diseases (PRDs), including  neglected ones.  

4.  Better  coordinate,  align  and,  where  appropriate,  integrate  relevant 
national  programmes  to  increase  the  cost-effectiveness  of  European 
public  investments.   

5.  Extend  international  cooperation  with  other  public  and  private  partners 
to  ensure  that  the  impact  of  all  research  is  maximised  and  that  possible 
synergetic effects are utilised.   

9 EDCTP2 Basic Act: Decision No 556/2014/EU of the European Parliament and of the Council 

of 15 May 2014  
on the participation of the Union in a second European and Developing Countries Clinical 
Trials Partnership Programme (EDCTP2) 

10 The objectives of the EDCTP2 programme are in full detail described in Annex 1 of 
Decision No 556/2014/EU of the European Parliament and of the Council of 15 May 2014 and 
are presented here in an abridged form.  

43 

 
 
                                              
 
6.  Increase 

impact  due 

to  effective  cooperation  with  relevant  EU 

initiatives,  including  its development  assistance. 

towards 

these  objectives.  For  each  objective 

following  section  assesses  survey  participants’  perceptions  about 
The 
EDCTP2’s  progress 
the 
questionnaire  asked  one  or  two  questions.  Respondents  were  either  asked  to 
agree  or  disagree with certain statements about EDCTP2’s progress towards its 
objectives or they were asked to rate EDCTP2’s activities in a certain area on a 
scale  from  “very  good”  to  “very  poor.”  Participants  always  had  the  option  to 
select “don’t  know” as a possible answer.      

6.1. 

Capacity Of Sub-Saharan African Countries To 

Conduct Clinical Trials  

A  significant  number  of  countries  in  sub-Saharan  Africa  still  lacks  the  basic 
infrastructure  and  expertise  to  conduct  clinical  trials  that  meet  international 
standards.  As  one  of  its  central  objectives,  EDCTP2  aims  to  strengthen  the 
capacities  of  both  individual  researchers  and  institutions  in  sub-Saharan  African 
countries  to  conduct  clinical  trials.  EDCTP2  funds  the  training  of  researchers 
and  other  staff,  as  well  as  the  development  and  extension  of  laboratories, 
clinical  trial  sites  and  research  centres.  The  following  two  questions  assessed 
survey  participants’  perceptions  about  EDCTP2’s  progress  towards  this  key 
objective.    

EDCTP2 contributes to strengthening the 
capacity of sub-Saharan African countries 
to conduct clinical trials. 

84% 

6% 

10% 

Agree 

Disagree 

Don't  know 

100% 

80% 

60% 

40% 

20% 

0% 

Figure 21 – SSA Countries’ Capacity to Conduct Clinical Trials  

44 

 
 
 
 
 
 
 
 
 
 
     
 
A  very  large  majority  of  84%  of  respondents  agrees  that  EDCTP2 strengthens 
the  capacity  of  countries  in  sub-Saharan  Africa  to  conduct clinical trials. 6% of 
survey  participants  disagreed  with  this  statement.  10%  of  respondents  selected 
“don’t  know” as their response.  
Importantly,  the  questionnaire  not  only  asked  about  EDCTP2’s  contribution  to 
strengthening  countries’  capacities  to  conduct  clinical  trials,  but  also  addressed 
the  issue  of  whether  its  funding  priorities  reflect  the  needs  of  sub-Saharan 
African countries,  as perceived by the respondents  themselves.   

The funding priorities of the EDCTP2 
programme reflect the needs of sub-
Saharan African countries. 

70% 

90% 

70% 

50% 

30% 

10% 

22% 

7% 

-10% 

Agree 

Disagree 

Don't  know 

Figure 22 – Funding Priorities Reflect Needs of SSA Countries  

In  an  open  question  that  followed,  respondents  were  asked  to  briefly  elaborate 
on  where  they  think  EDCTP2’s  funding  priorities  might  diverge  from the needs 
of  sub-Saharan  African  countries.  Here,  respondents  formulated  two  general 
criticisms  of  EDCTP2’s  funding  priorities.  First,  there  is  a  lack  of  involvement 
of  African  countries  when  it  comes  to  the  process  through  which  priorities  are 
selected.  Second,  needs  vary  from  country  to  country  and  region  to  region, 
which  is  not  reflected  by  the  EDCTP2  programme.  In  this  context,  one 
respondent  suggested  that  the  networks  of  excellence  monitor regional  priorities 
and  then discuss these at meetings of the Scientific Advisory Committee (SAC). 
Additionally,  a  number  of  respondents  mentioned  non-communicable  diseases 
(NCDs) as a need that is not reflected by EDCTP2’s funding  priorities.   

45 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.2. 

 Cooperation Between European And Sub-Saharan 

African Countries  

There  is  widespread  agreement  among  stakeholder  that  EDCTP2  strengthens 
cooperation  between  European  and  sub-Saharan  African  countries.  73%  of 
respondents  rated  EDCTP2’s  activities  in  this  area  as  either  “very  good”  or 
“good”.    4%  of  respondents  rated  EDCTP2’s  efforts  to  strengthen  cooperation 
as “poor” or “very poor”.   

In your opinion, how would you rate EDCTP2's activities to 
strengthen cooperation between European and sub-Saharan 
African countries? 

36% 

37% 

19% 

50%
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%

3% 

1% 

3% 

very good

good

fair

poor

very poor

don't know

Figure 23 – Cooperation between European and SSA countries   

6.3. 

 New Or Improved Medical Interventions For 

HIV/Aids, TB, Malaria  & Other PRNDs   

The  term  poverty-related  and  neglected  diseases  (PRNDs),  groups  together  a 
number  of  infectious  diseases  that  disproportionally  affect  the  world’s  poorest 
and  most  vulnerable  populations.  The  three  most  widespread  diseases  that 
belong  to  this  category  are  HIV/Aids,  tuberculosis  and  malaria.  Additionally, 
the  term  also  encompasses  17  so-called  neglected  tropical diseases. EDCTP2’s 
research  focus  includes  only  PRNDS  prevalent  in  sub-Saharan  Africa.  Chagas 
disease,  for  instance,  which  is  mostly  prevalent  in  Latin  America,  is  not 
addressed within  the EDCTP2 framework. 

Medical  interventions  aimed  at  PRNDs  tend  to  stagnate  in  the  development 
pipeline  due  to  a  lack  of  commercial  interest  in  bringing  them  to  market. 

46 

 
 
 
 
 
 
 
 
 
 
 
 
 
EDCTP2  aims  to  help  these  health  products  along  the  development  pipeline 
from  phase  I  to  IV,  thereby  increasing  the  number  of  medical  interventions 
available  to  patients  in  developing  countries.  84  %  of  survey  respondents 
perceive  EDCTP2  to  contribute  to  increasing  the  number  of  new  or  improved 
medical  interventions  for HIV/AIDS, tuberculosis,  malaria  and other PRNDs.  

EDCTP2 is contributing to increasing the 
number of new or improved medical 
interventions for HIV/AIDS, tuberculosis, 
malaria and other PRNDs 

84% 

4% 

12% 

Agree 

Disagree 

Don't  know 

100% 

80% 

60% 

40% 

20% 

0% 

Figure 24 – New or Improved Medical Interventions 

EDCTP2 is contributing to the development 
of guidelines for improving or extending 
the use of existing medical interventions. 

67% 

90% 

80% 

70% 

60% 

50% 

40% 

30% 

20% 

10% 

0% 

27% 

6% 

Agree 

Disagree 

Don't  know 

Figure 25 – Guidelines for Existing Medical Interventions  

47 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.4. 

 Integration Of National  Programmes  

EDCTP2  also  endeavours  to  accelerate  the  development  of  new  clinical 
interventions  by  providing  a  critical  mass  of  resources  through  the  more 
efficient  and  effective  use  of  European  research  capacities.  For  this  reason, 
EDCTP2  aims  to  integrate  and  coordinate  the  national  programmes  of  the 
Participating  States  (PSs)  through  the  joint  EDCTP  scientific  administration 
and common  funding.11   

EDCTP2’s  Strategic  Business  Plan  2016  defines  coordination  of  national 
programmes  as  “the  organisation  and  harmonisation  of  Participating  States’ 
activities  and  projects  within  the  scope  of  EDCTP  with  developing  countries 
into  synergistic  and  efficient  joint  ventures  with  common  scientific  review, 
oversight  and  administration  including  monitoring  and  evaluation  as  part  of 
common  programming”.12 

EDCTP2 is contributing to the integration of 
national programmes and has thereby 
increased the cost-effectiveness of European 
public investments. 

39% 

46% 

15% 

90% 
80% 
70% 
60% 
50% 
40% 
30% 
20% 
10% 
0% 

Agree 

Disagree 

Don't  know 

Figure 26 – Integration of National Programmes  

11 EDCTP2 Strategic Business Plan – May 2016, page 8  

12 EDCTP2 Strategic Business Plan – May 2016, page 54  

48 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                              
When it comes to EDCTP2’s success in progressing towards this goal, there is a 
relatively  high 
level  of  uncertainty  among  stakeholders,  with  46%  of 
respondents  selecting  “don’t  know”  as  their answer. 39% of survey participants 
indicated  their  agreement  with  the  statement  that  EDCTP2 contributes to  the 
integration  of  national  programmes  and  has  thereby  increased  the  cost-
to  15%  of 
effectiveness  of  European  public 
respondents who disagreed with  the statement. 

investments,  as  opposed 

6.5. 

International Cooperation With Other Public And 

Private Partners 

As  part  of  its  networking  activities,  EDCTP2  aims  to  attract  and  leverage 
additional  financial  investments  from  other  public  and  private  funders.  This 
includes  development  cooperation  partners,  product  development  partnerships 
(PDPs),  philanthropic  and  charitable  organisations,  pharmaceutical  companies, 
small  and  medium-sized  companies  (SMEs),  non-governmental  organisations 
and non-European  Union  (EU) countries.13 

Almost  half  of  survey  participants  (48%)  were  aware  of  cooperation  efforts 
with  other  public  and  private  partners,  as opposed to 10% who believed no joint 
calls  and/or  other  activities  with public  and  private  funders  have  been  launched 
under the EDCTP2 programme. 42 % of respondents selected “don’t  know”. 

As far as you know, have joint calls and/or 
other activities with  public and private 
funders been launched under the EDCTP2 
programme? 

70% 

50% 

30% 

10% 

-10% 

48% 

Yes 

42% 

Don't  know 

10% 

No  

Figure 27 – International Cooperation with Public and Private Partners 

13 EDCTP2 Strategic Business Plan – May 2016, page 26 

49 

 
 
 
 
 
 
 
 
 
 
 
                                              
6.6. 

Cooperation With Other Relevant European Union 

Initiatives 

The  EU  is  one  the  major  donors  and  one  of  strongest  players  in  international 
health  aid  and  research.  However,  a  lack  of cooperation limits the EU’s impact 
and visibility  in this field.   

Over the past decade, a series of policy statements and collaborative agreements 
have  laid  the  foundation  for  a  stronger  position  of  the  EU  in  global  health.  In 
2010,  the  Commission  Communication  and  Council  Conclusions  on  the  Role  of 
Europe  in  Global  Health  (2010)  established  a  conceptual  framework,  with 
emphasis  on  strengthening  national  health  systems,  maternal  health  and  the 
continued  fight  against  HIV,  tuberculosis  and  malaria.  EDCTP2  aims  to 
contribute  towards  a  coherent  EU  position  in  global  health  by  fostering 
cooperation  with  other  relevant  European  Union  Initiatives,  including  its 
development  assistance.14  

Out  of  all  of  EDCTP2’s  objectives,  stakeholder  perceptions  here  indicate  the 
least  amount  of  progress  when  it  comes  to  this  goal.  Only  22%  of  participants 
said  that  they  were  aware  of  actions  taken  to  increase  EDCTP2’s  impact  by 
cooperating  with  other  EU  initiatives.  15%  of  respondents  believe  no  such 
actions were taken, while  63% selected “don’t  know.” 

As far as you know, have actions been taken 
under the EDCTP2 programme to increase its 
impact by effectively cooperating with other 
relevant European Union initiatives, including 
its development assistance programmes?  

63% 

22% 

Yes 

15% 

No  

Don't  know 

80% 

60% 

40% 

20% 

0% 

Figure 28 – Cooperation with Other Relevant EU Initiatives  

14 EDCTP2 Strategic Business Plan – May 2016, page 8  

50 

 
 
 
 
 
 
 
 
 
 
 
 
                                              
6.7. 

Progress Towards Objectives – Results Divided by 

Category of Respondent 

When  respondents  were  asked  to  rate  EDCTP2's  contribution  to  strengthening 
the  capacity  of  sub-Saharan  African  countries  to  conduct  clinical  trials,  all  of 
the  negative  responses  came  from  stakeholders  belonging  to  the  “funded  or 
applied  for  funding”  category.  However,  considering  that  the  overall  share  of 
negative  feedback  for  this  question  was  very  low,  this  discrepancy  should  not 
undermine  the validity  of the first result.   

Rating of EDCTP2's Contribution to Strenghteniong 
the Capacity of sub-Saharan African Countries to 
Conduct Clinical Trials by Respondents' Type of 
Involvement 

0%

5% 10% 15% 20% 25% 30% 35% 40%

34% 

Funded or Applied for Funding

Member of the General Assembly

0% 
0% 

Other Type of Involvement

0% 

5% 
4% 

4% 

No Involvement

Member of the SAC

0% 

1% 

1% 

0% 
0% 

18% 

15% 

15% 

Positive

Negative

Don't know

Figure 29 – Capacity Strengthening for CTs by Respondents' Type of Involvement  

51 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The  following  two  questions  were  analysed  by  respondents’  geographic 
location  (Europe  or  sub-Saharan  Africa),  again  with  the  goal  to  detect  possible 
biases where relevant:   

-  How would  you rate EDCTP2's activities  to strengthen cooperation 
between European and sub-Saharan African countries? (positive  / 
neutral / negative  / don’t know) 

-  The funding  priorities  of EDCTP2 reflect the needs of sub-Saharan 

African countries. (agree / disagree / don’t know)   

A  majority  of  76%  of  responses  came  from  stakeholders  in  Europe.  22%  of 
responses  came  from  survey  participants  in  sub-Saharan  Africa  and  2%  of 
responses  came  from  other  regions.  Compared  to  a  public  consultation  carried 
out  in  2012  the  participation  rate  among  African  stakeholders  was  slightly 
lower.  In  2012,  58%  of  responses  came  from  Europe,  27%  from  Africa  and 
14% from other regions.  

How would you rate EDCTP2's activities to 
strengthen cooperation between European 
and sub-Saharan African countries? 

73% 

73% 

20% 

13% 

7% 

5% 

7% 

2% 

80%

70%

60%

50%

40%

30%

20%

10%

0%

Positive

Neutral

Negative

Don't know

Responses from Africa

Responses from EU & Others

Figure 30 – Europe – SSA Cooperation by Location of Respondents  

52 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Two  questions  where  discrepancies  between  respondents  from  Africa  and 
Europe  might  be  suspected  were  analysed  by  respondents’  geographic location. 
When  stakeholders  were  asked  to  rate  EDCTP2's activities to  strengthen 
cooperation  between  European  and  sub-Saharan  African  countries,  no 
significant  disparities  between  African  and  European  stakeholders  were  found. 
However,  when  respondents  were  asked  if  the  funding  priorities  of  EDCTP2 
reflect  the needs  of  sub-Saharan  African  countries,  analysis  by  respondents’ 
geographic  location  revealed  such  a  discrepancy: respondents from Africa were 
significantly  less  likely  to  agree  that  EDCTP2’s  funding  priorities  reflect  the 
needs of sub-Saharan African countries and they were more than twice as likely 
to disagree with  the statement.  

The funding priorities of EDCTP2 reflect the needs of 
sub-Saharan African countries. 

73% 

60% 

27% 

21% 

13% 

6% 

80%

70%

60%

50%

40%

30%

20%

10%

0%

Agree

Disagree

Don't know

Responses from Africa

Responses from  EU & Others

Figure 31 – Funding Priorities Reflecting the Needs of SSA Countries 

53 

 
 
 
 
 
 
7.  Governance & Management  

Ireland, 

(Austria,  Denmark,  Finland,  France,  Germany, 

The  EDCTP  Association,  which  was  established  in  April 2014 and is registered 
in  the  Netherlands  under  Dutch  law,  is  the  legal  governing,  executive  and 
representative  body  of  the  EDCTP2  programme.  At  the  moment,  14  European 
states 
Italy, 
Luxembourg,  The  Netherlands,  Norway,  Portugal,  Spain,  Sweden  and  the 
United  Kingdom)  and  14  African  states  (Cameroon,  Burkina  Faso,  Congo, 
Gabon,  The  Gambia,  Ghana,  Mali,  Mozambique,  Niger,  Senegal,  South  Africa, 
Tanzania,  Uganda  and  Zambia)  are  full  members  of  the  EDCTP  Association. 
Each  member  state  has  one  vote. As opposed to EDCTP1’s institutional set-up, 
it  is  not  possible  to  join  EDCTP2  as  an  associate  member.  However,  countries 
eligible  to  join,  who  have  not  yet  made  a  decision  to  do  so,  may  be  invited  to 
attend  meetings  of  the  General  Assembly.  EDCTP2’s  governance  structure 
consists of a General Assembly (GA), the Board of the EDCTP Association and 
the  Executive  Secretariat.  There’s  also a Scientific Advisory Committee (SAC), 
which deals with scientific  and strategic matters.  

The  General  Assembly,  in  which  all  members  are  represented,  is  the  ultimate 
and  exclusive  decision-making  body  of  the  EDCTP-Association.  Its  principal 
responsibility  is  to  ensure  that  all  necessary  activities  are undertaken to achieve 
the  statutory  objectives  of  the  programme.  It  is  also  tasked  with  ensuring  that 
EDCTP2’s resources are managed efficiently.   

The Board of the EDCTP-Association consists of members of the GA that were 
nominated  for  board  membership.  The  Board  is  entrusted with the management 
of  the  Association  and  supervises  the  Secretariat  in  preparing the Association’s 
annual  work plan  and multi-annual  strategic work plan.   

The  Secretariat  is  EDCTP2’s  executive  body.  It  is  in  charge  of  implementing 
the  EDCTP  programme,  assuring  the  day-to-day  management  of  EDCTP  and 
providing  support  to  other  EDCTP  bodies.  The  Secretariat  is  fully  responsible 
for  the  execution  of  the EDCTP2 programme and is accountable to the General 
Assembly.   

In  its  governance  and  management  section,  the  survey  questionnaire  asked 
respondents  to  provide  their  opinion  on  the  following  aspects  of the governance 
and management  of the EDCTP2 programme:   

1.  Overall  Management and Execution  of the Programme   

54 

 
 
2.  Strategy and processes for setting EDCTP2's funding  priorities 
3.  Funding  mechanisms  to  support  clinical  trials  research  in  sub-Saharan 

Africa 

4.  Funding  mechanisms 

to strengthen the  capacities  of  sub-Saharan 

African countries to conduct clinical  trials 

5.  EDCTP2’s proposal  evaluation  and selection  process 
6.  EDCTP2's proposal,  submission  and grant management tools 
7.  EDCTP2's policies  to prevent conflicts  of interest 
8.  Implementation  of recommendations  from previous  evaluations    

7.1. 

Management And Execution Of The EDCTP2 

Programme 

Overall  most  respondents  have  a  positive  view  of  the  management  and 
execution  of  EDCTP2.  A  majority  of  58%  of  respondents  rates  EDCTP2’s 
management  as  either  “very  good”  or  “good”,  as  opposed  to  11%  who  gave  a 
rating  of  “poor”  or  “very  poor”.  Almost  a  fifth  (19%)  of  survey  participants 
rated EDCTP2’s management as “fair”.  

Overall, how would you rate the management and 
execution of the EDCTP2 programme? 

42% 

16% 

19% 

50%

45%

40%

35%

30%

25%

20%

15%

10%

5%

0%

10% 

10% 

1% 

very good

good

fair

poor

very poor

don't know

Figure 32 – Overall Management & Execution 

55 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.2. 

Strategy And Processes For Setting EDCTP2's 

Funding Priorities 

As  with  the  overall  management  and  execution  of  the  EDCTP2  programme,  a 
majority  of respondents (55%) has a positive view of the strategy and processes 
that  are  in  place  for  setting  EDCTP2’s  funding  priorities.  As  with  the  question 
before  a  similar  proportion  of  participants  (22%)  gave  a  rating  of “fair”. 7% of 
respondents  expressed  a  negative  view  of  the  current  processes  by  which 
EDCTP2’s  funding  priorities  are  determined  and  gave  a  rating  of  either  “poor” 
or “very poor”. 

Overall, how would you rate the strategy and 
processes for setting EDCTP2's funding priorities? 

46% 

22% 

9% 

15% 

4% 

3% 

50%

45%

40%

35%

30%

25%

20%

15%

10%

5%

0%

very good

good

fair

poor

very poor

don't know

Figure 33 – Strategy & Processes for Setting EDCTP2’s Funding Priorities  

7.3. 

Funding To Support Clinical Trials Research In 

Sub-Saharan Africa 

Compared  to  the  previous  two  aspects  of  EDCTP2’s  governance,  a  larger 
number  of  respondents  expressed  confidence  in  the  funding  mechanisms  that 
exist  to  finance  clinical  trials  research  in  sub-Saharan  Africa.  65%  of 
participants  rated  these  mechanisms  as  either  “very  good”  or  “good”,  as 
opposed  to  11%  who  rated  them as “poor” or “very poor”. 12% of respondents 
view them as “fair”.   

56 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In your opinion, how would you rate EDCTP2's 
funding mechanisms to support clinical trials 
research in sub-Saharan Africa? 

40% 

25% 

50%
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%

12% 

10% 

10% 

1% 

very good

good

fair

poor

very poor

don't know

Figure 34 – Funding to Support Clinical Trials Research in SSA 

7.4. 

 Funding To Strengthen The Capacities Of SAA 

Countries To Conduct Clinical Trials 

The  funding  mechanisms  that  are  in  place  to  finance  capacity building activities 
received  a  similarly  favourable  review.  63%  of  survey  participants  see them as 
either “very good” or “good”;  18 % as “fair”, and 9% as “poor” or “very poor”.   

In your opinion, how would you rate EDCTP2's funding 
mechanisms to strengthen the capacities of sub-Saharan 
African countries to conduct clinical trials? 

39% 

24% 

18% 

50%

45%

40%

35%

30%

25%

20%

15%

10%

5%

0%

6% 

3% 

10% 

very good

good

fair

poor

very poor

don't know

Figure 35 – Funding to Support SSA Countries’ Capacity to Conduct Clinical Trials  

57 

 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
7.5. 

 Quality And Transparency Of EDCTP2's Proposal 

Evaluation And Selection Process 

Compared  to  the  satisfaction  that  a  majority  of  stakeholders expressed with 
the  funding  mechanisms  for  clinical  trials  and  capacity  building  activities, 
EDCTP2’s  proposal  evaluation  and  selection  process  received  considerably 
less  positive  feedback.  Less  than  half  of  respondents  (42%)  view  the 
proposal  evaluation  and  selection  process  favourably.  Out  of  all governance 
&  management  activities  that  participants  were  asked  to  rate,  EDCTP’s 
proposal  evaluation  and  selection  process  received  the  lowest  proportion  of 
positive  reviews and by far the highest share of negative  reviews (25%).  

In your opinion, how would you rate the quality 
and transparency of EDCTP2's proposal evaluation 
and selection process 

50%
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%

27% 

15% 

18% 

19% 

15% 

6% 

very good

good

fair

poor

very poor

don't know

Figure 36 – Quality & Transparency of Proposal Evaluation and Selection Process 

7.6. 

Effectiveness Of EDCTP2's Proposal, Submission 

And Grant Management Tools 

Respondents  were  also  asked  to rate EDCTP2’s proposal, submission and grant 
management  tools.  These  received  approximately  the  same  share  of  positive 
reviews  (54%)  as  EDCTP2’s  strategy  and  processes  for  setting  funding 
priorities  (55%).  However,  with  10%  of  participants  rating  the  proposal, 
submission  and  grant  management  tools  as  either  “poor”  or  “very  poor”,  they 
received a higher share of negative feedback.  

58 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
In your opinion, how would you rate the 
effectiveness of EDCTP2's proposal, submission 
and grant management tools? 

39% 

15% 

22% 

50%

40%

30%

20%

10%

0%

13% 

7% 

3% 

very good

good

fair

poor

very poor

don't know

Figure 37 – Effectiveness of Proposal, Submission and Grant Management Tools  

7.7. 

Prevention Of Conflicts Of Interest 

Compared  to  other  aspects  of  EDCTP2’s  governance  and management, survey 
participants  were  somewhat  less  familiar  with  EDCTP2’s  policies  to  prevent 
conflicts  of  interest.  This  question  received  a  significantly  higher  proportion  of 
respondents  selecting  “don’t  know”  as their answer. Nevertheless, a majority of 
participants  (54%)  rated  EDCTP2’s  policies  to  prevent  conflicts  of  interest 
positively.    

In your opinion, how would you rate the 
effectiveness of EDCTP2's policies to prevent 
conflicts of interest ? 

50%

40%

30%

20%

10%

0%

30% 

24% 

27% 

12% 

6% 

1% 

very good

good

fair

poor

very poor

don't know

Figure 38 – Conflict of Interest Prevention Policies  

59 

 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.8. 

Implementation Of Previous Recommendations  

One  of  the  purposes  of  consultations  is  of  course  to  identify  problems  in  order 
to  optimise  processes  and  maximise  the  impact  of  public  investments.  Once 
potential  issues  have  been  identified,  recommendations  are  formulated  to 
address  them.  However,  evaluations  and  consultations  only  serve  their  purpose 
if  these  recommendations  are  also  implemented.  For  this  reason,  the  survey 
questionnaire  asked  respondents,  if  they  knew  of  recommendations  from 
previous  evaluations  of  EDCTP1  that  have  been  successfully  implemented 
under  EDCTP2.  This  question  was  asked  in  specific  reference  to  the  2009 
evaluation  of  EDCTP1  and  respondents  were  provided  with  a  link  to  the  2009 
evaluation  report.  

As far as you know, have recommendations 
from the 2009 evaluation of EDCTP1 been 
successfully implemented? 

66% 

27% 

Yes 

7% 

No  

Don't  know 

70% 

60% 

50% 

40% 

30% 

20% 

10% 

0% 

Figure 39 – Implementation of Previous Recommendations  

In  a  follow-up  question,  respondents  were  asked  to  “cite  one  example  of  a 
change  that  was  made  based  on  recommendations  from  previous  evaluations.” 
A  majority  of  respondents  (66%)  selected  “don’t  know”  as  their  answer  and 
another  7%  selected  “no”.  However,  while  most  survey  participants  were 
unaware  of  successfully  implemented  recommendations  based  on the evaluation 
of  EDCTP1,  there  was  still  a  relatively  large  group  of 27% of respondents that 
was  aware  of  such  successfully  implemented  changes.  The  most  often  cited 
examples  were  the  inclusion  of  neglected  tropical  diseases  (NTDs)  and  the 
simplification  of co-funding  rules.   

60 

 
 
 
 
 
 
 
 
 
 
 
 
 
Examples Cited of Changes Based on 
Recommendations from Previous Evaluations  

20% 

33% 

20% 

27% 

Inclusion of NTDs

Simplification of co-funding rules

Increased role of African states in the governance of EDCTP

Other Examples

Figure 40 - Changes Based on Recommendations from Previous Evaluations 

In  response  to  this  open  question,  the  most  often  brought  up  example  of  a 
successfully  implemented  recommendation  was  the  inclusion  of  research  into 
neglected  tropical  diseases  (NTDs)  in  EDCTP2’s  funding  framework.  Of  the 
27%  of  respondents  who  selected  “yes”  as  their  response,  33%  mentioned  the 
inclusion  of  NTDs.  The  second  most  cited  positive  change  was 
the 
simplification  of  co-funding  rules  (27%).  Another  20%  of  this  sub-group  of 
respondents  mentioned  the increased role of African states in the governance of 
EDCTP as an example of a successfully  implemented  recommendation. 

7.9. 

Overview of Governance and Management 

Activities   

To  facilitate  the  analysis  of  results  the  first  and  second  answer  (“very  good”, 
“good”)  were  added  together  and  classified  as  “positive  feedback”;  the  third 
answer  choice  “fair”  is  reflected  as  “neutral  feedback” in figure 37. The fourth 
and  fifth  category  of  responses  (“poor”,  “very  poor”)  were  added  together and 
classified  as  “negative  feedback”.  This  makes  it  easier  to  compare  results  for 
different aspects of EDCTP2’s governance and management.   

61 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ranking of Governance & Management Activities 

Funding Mechanisms for Clinical Trials Research

Funding Mechanisms for Capacity Building Activities

Setting of Funding Priorities

Conflict of Interest Prevention

Proposal Submission and Grant Management

65% 

63% 

55% 

54% 

54% 

12% 

11% 

18% 

9% 

22% 

7% 

12% 

7% 

22% 

10% 

Proposal Evaluation and Selection

42% 

18% 

25% 

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Positive

Neutral

Negative

Figure 41 – Ranking of Governance and Management Activities  

The  picture  that  emerges  from  this  analysis  shows  that  stakeholders’  opinions 
shifted  when  they  were  asked  to  rate  different  components  of  EDCTP2’s 
governance  and  management.  Stakeholder  views of EDCTP2’s governance and 
management  fall  into three separate groups. EDCTP2’s funding mechanisms for 
clinical  trials  research  and  capacity  building  activities  belong  to  the  first  group. 
The  components  in  this  group  received  the  highest  share  of  positive  feedback 
and  either  no  or  only  very  few  negative  mentions  in  answers  to  the  open 
questions.  Overall,  survey  participants  expressed  confidence  in  these aspects of 
EDCTP2’s  governance  and  management.  The  second group consists of funding 
priorities  processes  and  conflict  of  interest  prevention  policies.  While  there was 
that  expressed  positive  views  of  these 
still  a  majority  of  respondents 
components, 
the 
they 
components  in  the  first  group.  EDCTP2’s  proposal  submission  and  grant 
management  tools  and  its  proposal evaluation and selection processes are left to 
form  the  third  group.  These  two  components  received  the  lowest  proportion  of 
positive feedback and the the highest share of negative feedback in respondents’ 

less  decidedly  positive 

feedback 

received 

than 

62 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
answers  to  open  questions.  Generally,  this  fits  with  the  results  from  the  first 
question  in  the  governance  &  management  section  of  the  questionnaire.  Here 
survey  participants  were asked to rate the overall management and execution of 
the  EDCTP2  programme.  A  majority  of  58%  of  respondents  rated  EDCTP2’s 
management  as  either  “very  good”  or  “good”  (positive),  as  opposed  to  11% 
who  gave  a  rating  of  “poor”  or  “very  poor”  (negative).  19%  of  survey 
participants  rated  EDCTP2’s  management  as  “fair”  (neutral).  Underscoring the 
robustness  of  the  findings,  the  averages  from  the  individually  rated  governance 
and  management  activities  are  very  similar  to  these  results:  56%  positive, 
17,5% neutral  and 11% negative.   

7.10. 

Governance & Management – Results Divided by 

Category of Respondent  

EDCTP2’s  proposal  evaluation  and  selection  process  was  selected  for  analysis 
by  type  respondent,  because  it  received  both  the  lowest  share  of  positive 
feedback  as  well  as  the  highest  share  of  negative  feedback  in  the  governance 
and  management  section.  Unsurprisingly,  members  belonging  to  the  “funded  or 
applied  for  funding”  category  provided  most  of  the  unfavourable  reviews  – 
even  adjusted  for  group  size.  However,  members of the General Assembly also 
accounted  for  a  significant  share  of  the  negative  responses.  Similarly, 
unsurprising  when  asked  to  rate  the  management  and  execution  of  EDCTP2 
members  of  the  General  Assembly were much less critical and almost all of the 
negative  responses  came  from  stakeholders  belonging  to  the  “funded  or applied 
for  funding”  category.  When  discussing  the  results, it is important to keep these 
biases in  mind. 

63 

 
 
 
  
 
 
 
 
 
 
Rating of EDCTP2's Proposal Evaluation and Selection 
Process by Respondents' Type of Involvement 

0%

2%

4%

6%

8% 10% 12% 14% 16% 18% 20%

14% 

18% 

11% 

Funded or Applied for Funding

Member of the General Assembly

3% 

4% 

0% 

Other Type of Involvement

1% 

3% 

No Involvement

Member of the SAC

1% 
1% 

1% 

0% 
0% 
0% 

6% 

6% 

7% 
7% 

7% 

6% 

Positive

Neutral

Negative

Don't know

Figure  42  –  Proposal  Evaluation  and Selection Process by Respondents' Type of 
Involvement 

64 

 
 
 
 
 
 
 
 
 
Rating of EDCTP2's Managment and Execution by 
Respondents' Type of Involvement 

0%

5%

10%

15%

20%

25%

22% 

15% 

Funded or Applied for Funding

7% 

10% 

4% 

Member of the General Assembly

Other Type of Involvement

3% 

0% 
0% 

0% 

1% 

12% 

6% 

No Involvement

7% 

3% 

1% 

4% 

Member of the SAC

1% 

0% 
0% 
0% 

Positive

Neutral

Negative

Don't know

Figure 43 – Management and Execution by Respondents' Type of Involvement 

65 

 
 
 
 
 
8.  RESPONDENTS’ OVERALL ASSESSMENT AND 

RECOMMENDATIONS  

The  questionnaire’s  final  section  consisted  of  three  open  questions.  First, 
respondents  were asked to evaluate EDCTP2 in terms of key strengths. 63% of 
survey  participants  answered  this  first  open question. Second, respondents were 
asked 
to  assess  the  EDCTP2  programme  in  terms  of  weaknesses  or 
opportunities  for  improvement.  Slightly  fewer  survey  participants  (60%)  chose 
to  answer  this  second  open  question.  Third,  respondents  were  asked  to provide 
specific 
the  EDCTP2 
programme.  This question  was answered by 61% of survey participants.   

recommendations  about 

future  direction  of 

the 

8.1. 

Strengths  

Of  the  63%  of  respondents  who  provided  their  opinion  on  the  strengths  of  the 
EDCTP2  programme,  24%  mentioned  capacity  building  activities 
(e.g. 
investments  in  skill-building  measures,  an  increased  number  of  fellowships)  as 
one  of  EDCTP2’s  key  strengths.  12  %  of  respondents  cited  the  broadening  of 
EDCTP2’s  disease  scope  to  include  poverty-related  and  neglected  diseases 
(PRNDs)  as  a  key  strength.  Fewer  respondents  mentioned  the  facilitation  of 
health research cooperation across sub-Saharan Africa and between Europe and 
Africa  (7%) and calls for diagnostic products (7%) as strengths of the EDCTP2 
programme.   

Frequently Cited Key Strenghts of EDCTP2 

24% 

12% 

7% 

7% 

30%

25%

20%

15%

10%

5%

0%

Capacity Building
Activities

Increased Breadth of
Disease Scope

Calls for Diagnostic
Products

Facilitation of Health
Research Cooperation

Figure 44 – Key Strenghts  

66 

 
 
 
 
 
 
 
 
 
 
 
 
 
8.2. 

Weaknesses & Opportunities for Improvement  

the 

This  open  question  received  a  variety  of  different  responses.  Despite  the  very 
large  number  of  issues  that  were  brought  up  in  response  to  this  question  there 
were  four  concerns  that  were  raised  by  several  respondents.  First,  23%  of 
respondents  complained  about 
inferior  quality  of  EDCTP2’s  grant 
management  and  proposal  submission  processes.  Many  of  these  complaints 
included  criticisms  about  the  grant  submission  process  being  being  too  slow 
and  laborious,  frequent  delays  and  changes  of  deadlines  and  some  stakeholders 
also  criticised  the  quality  of  reviews.    Second,  13%  of  respondents  protested 
that  the  evaluation  process  is  insufficiently  transparent.  They  demanded  more 
transparency  when  it  comes  to  the  selection  of  funding  priorities,  the  process 
through  which  funding  decisions  are  made  and  the  reporting  of  conflicts  of 
interest.  Third,  10%  of  respondents  disapproved  of  the  current  level  of 
cooperation  with  third  parties  and  suggested  increased  cooperation  with  third 
party  organisations  such  as  UNITAID  or  the  Global  Fund.  Fourth,  8%  of 
respondents  complained  about  the  late  publication  of  the  strategic  business  plan 
and the annual  work plans,  which made it difficult  for applicants  to plan  ahead.  

Frequently Cited Weaknesses of EDCTP2 

23% 

13% 

10% 

8% 

25%

20%

15%

10%

5%

0%

Inferior Quality of
Grant Management
and Proposal
Submission Processes

Lack of Transparency of
Evaluation Process

Lack of Cooperation
with Third Party
Organisations

Late Publication of
Strategic Business Plan
and Annual Work Plans

Figure 45 – Weaknesses   

67 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.3. 

Recommendations about the future direction of 

EDCTP2  

There was some overlap  in the responses to the previous  question  and this 
question.  The most frequently  cited recommendations  about the future direction 
of EDCTP2 are summarised  in  the list  below:   

-  Simplify  the grant submission  process.  

- 

- 

Increase transparency of funding  decisions,  setting  of funding  priorities 
and the reporting  of conflicts  of interest.   

Improve  transparency when it comes to the selection  of reviewers 
involved  in  proposal  evaluation.   

-  Ensure the distribution  of funding  is balanced across different diseases / 

groups  of diseases. 

-  Allow  for more flexibility  when it comes to changing  research 

programmes  after they have been funded. 

- 

- 

Include  affordable access provisions  in  model  grant agreement.  

Improve  communication  with applicants  when it comes to changes to 
calls.   

- 

Improve  collaboration  with  product development  partnerships.   

-  Provide  greater  clarity  regarding  EDCTP’s  objectives  for  private  sector 
participation  and  reflection  on  how  to  achieve  better  public-private 
dialogue    

68 

 
 
 
  
 
 
 
 
9.  CONCLUSIONS 

A  public  consultation  was  conducted  from  29  June  2016 to 15 November 2016. 
The  consultation  invited  the  stakeholders  of  the  European  and  Developing 
research 
Countries  Clinical  Trials  Partnership 
institutions, 
pharmaceutical 
regulatory 
companies,  etc.)  and  the  general  public  to  express  their  views  on  the 
implementation  of  the  EDCTP2  programme  during  the  period  2014-2016.  The 
consultation  was  carried  out  via  an  online  questionnaire  and  received  a  total  of 
67 responses.  

(i.e.  health 
funding 

researchers, 

authorities, 

agencies, 

9.1. Respondent Profile 

by 

government 

The  majority  of  responses  came from universities and research institutes (42%), 
followed 
non-governmental 
administrations 
organisations  (15%),  private  non-profit  organisations  (15%),  other  for-profit 
organisations 
large 
pharmaceutical  companies  (2%).  

(4%),  small  or  medium-sized  enterprises  (3%)  and 

(19%), 

76%  of  responses  came  from  survey  participants  in  Europe.  22%  of  responses 
came  from  survey  participants  in  sub-Saharan  Africa.  2%  of  responses  came 
from  other  regions.  Compared  to  a  public  consultation  carried  out  in  2012  the 
participation  rate  among  African  stakeholders  was  slightly  lower.  In  2012,  58% 
of responses came from Europe, 27% from Africa and 14% from other regions.   

The  largest  group  of  survey  participants  (44%)  were  stakeholders  that  have 
been  funded  by  EDCTP1  or  EDCTP2  in  the  past.  Another  7%  of  respondents 
have  applied  for  funding  from  EDCTP2.  17%  of  respondents  were  either 
members  of  the  EDCTP  General  Assembly  or  the  EDCTP  Scientific  Advisory 
Committee.  15%  of  respondents  had  no  prior  direct  involvement  with  EDCTP1 
or  EDCTP2  and  17%  of  respondents  described some other type of involvement 
with EDCTP1 or EDCTP2 in  the past.  

9.2. Advocacy and Communication 

With  an  overall  positive  rating  of  75%,  EDCTP2’s  communication  activities 
obtained  mostly  favourable  feedback.  However,  there  were  two  areas  that 
received  somewhat  less  decidedly  positive  reviews  (i.e.  more  than  25%  of 
combined  negative  or  neutral  feedback).  First,  35%  of  respondents  rated 
EDCTP’s  call  announcements  either  neutrally  or  negatively.  While  the 

69 

 
 
 
 
proportion  of  neutral  feedback  (25%)  was  significantly  higher  than  the 
proportion  of  negative  feedback  (10%),  Call  Announcements  still  received  the 
highest  share  of  negative 
the  seven  communication 
responses  across 
instruments  surveyed.  Second, 26% of respondents rated EDCTP2’s Applicant / 
Grantee  Support  either  neutrally  or  negatively.  Across  the instruments surveyed 
Applicant  /  Grantee  Support  received  the  second  highest  share  of  negative 
feedback  and  –  adjusted  for  those  respondents  who  selected  “don’t  know”  – it 
received 
lowest  share  of  positive  responses  of  all  communication 
instruments. 

the 

9.3. Progress towards EDCTP2's Objectives 

EDCTP2  was  created  to  strengthen  the  capacity  of  sub-Saharan  African 
countries  to  conduct  clinical  trials  in  compliance  with  fundamental  ethical 
principles  and  relevant  national,  EU  and  international  legislation.  Overall,  a  vast 
majority  (84%)  of  stakeholders  expressed  their  confidence  that  EDCTP2  is 
achieving  progress  towards  this  objective.  Only  6%  of  respondents  expressed 
the  concern  that  no  progress  towards  this  objective  is  being  made.  There  was 
somewhat  less  certainty  that  EDCTP2’s  funding  priorities  also  accurately 
reflect  the  needs  of  sub-Saharan  African  countries.  Overall,  70  %  of 
respondents  said  that  they  believe  that  EDCTP2’s  funding  priorities  reflect  the 
needs  of  sub-Saharan  African  countries.  However,  if  one  only  takes  into 
account  responses  that  came  from  respondents  in  sub-Saharan  Africa,  this 
number  falls  to  60%  and  the  number  of  those  who  believe there’s a mis-match 
between funding  priorities  and needs more than doubles  from 6% to 13%.  

EDCTP2  was  created  to  strengthen  cooperation  between  European  And  Sub-
Saharan African countries. Overall,  92% of respondents believe that EDCTP2 is 
progressing  towards  this  objective  and  73  %  of  respondents  rated  EDCTP2’s 
efforts  in  this  area  as  either  “very  good”  or  “good”.  Only  4%  of  stakeholders 
see  no  progress  when  it  comes  to  strengthening  cooperation between European 
and Sub-Saharan  African countries.   

EDCTP2  was  created  to  increase  the  number  of  new  or  improved  medical 
interventions  for  poverty-related  diseases  (PRDs),  including  neglected  ones. 
Overall,  84%  of  survey  participants  perceive  EDCTP2  to  be  making  progress 
when  it  comes  to  this  objective.  As  with  the  previous  objective  only  4%  of 
respondents were sceptical about EDCTP2’s performance in this  area.  

EDCTP2  was  created  to  contribute to  the  development  of  guidelines  for 

70 

 
 
 
improving  or  extending  the  use  of  existing  medical  interventions.  Overall,  67% 
of  respondents  were  of  the  opinion  that  EDCTP2  is  progressing  towards  this 
objective.  Compared  to  the  first  three  objectives,  a  somewhat  lower  proportion 
of  survey participants sees progress when it comes  to EDCTP2’s contribution to 
the  development  of  guidelines  for  improving  or  extending  the  use  of  existing 
medical  interventions.  However,  this  discrepancy  can  entirely  be  explained  by 
the  significantly  higher  number  of  respondents  (27%)  who  selected  “don’t 
know”  as  their  response  to  this  question.  6%  of  survey  participants  saw  no 
progress towards this particular  objective.     

EDCTP2  was  created  to  extend  international  cooperation  with  other  public  and 
private  partners  to  ensure  that  the  impact  of  all  research  is maximised and that 
possible  synergetic  effects  are  utilised.  Overall,  48%  of  stakeholders  see 
EDCTP2  as  making  progress  in  this  particular  area.  As  with  the  previous 
objective,  a  high  share  of  respondents  (42%) selected “don’t know”, while 10% 
of survey participants  perceive EDCTP2 as failing  to achieve this  goal.   

EDCTP2  was  created  to  better  coordinate,  align  and,  where  appropriate, 
integrate  relevant  national  programmes  to  increase  the  cost-effectiveness  of 
investments.  Overall,  39%  of  respondents  believe  that 
European  public 
EDCTP2  is  making  progress  towards  this  objective.  To  some  extent, this lower 
number  of  positive  responses  can  be  explained  by  the  circumstance that almost 
half  of  the  survey’s  participants  (46%)  selected  “don’t know” as their response 
to  this  question.  However,  there  is  also  a  higher  share  of  respondents  (15%) 
who believe  EDCTP2 is not making  any progress towards this objective.   

EDCTP2  was  created  to  increase  impact  due  to  effective  cooperation  with 
relevant  EU  initiatives,  including  its  development  assistance.  When  it  comes  to 
EDCTP2’s  success in progressing towards this goal, there was a very high level 
of  uncertainty  among  stakeholders,  with  63%  of  respondents  selecting  “don’t 
know”  as  their  answer.  22%  of  survey  participants  indicated  their  agreement 
with 
the  statement  that  EDCTP2 increases  its  impact  due  to  effective 
cooperation  with  relevant  EU  initiatives,  including  its  development  assistance, 
as opposed to 15% of respondents who disagreed with  the statement.  

In  summary,  stakeholders  seem  to  be  very  confident  that  EDCTP2  is  making 
progress towards its first four policy  objectives:   

1.  Strengthening  the  capacity  of  sub-Saharan  African  countries  to  conduct 

clinical  trials 

71 

 
 
2.  Strengthening  cooperation  between  European  And  Sub-Saharan  African 

countries 

3.  Increasing  the  number  of  new  or  improved  medical  interventions  for 

poverty-related  diseases (PRDs), including  neglected ones 

4.  Contributing to 

the  development  of  guidelines 
extending  the use of existing  medical  interventions 

for 

improving  or 

When it comes to EDCTP2’s other policy  objectives  the results were mixed:   

5.  Extending 

international  cooperation  with  other  public  and  private 
partners  to  ensure  that  the  impact  of  all  research  is  maximised and that 
possible  synergetic effects are utilised 

6.  Coordinating,  aligning  and,  where  appropriate, 

integrating  relevant 
national  programmes  to  increase  the  cost-effectiveness  of  European 
public  investments 

7.  Increasing  impact  due  to  effective  cooperation  with  relevant  EU 

initiatives,  including  its development  assistance 

First,  stakeholders  were  generally  less  well  informed  with  42%,  46%  and  63% 
respectively  selecting  “don’t  know”  in  response  to  the  questions  that  targeted 
these  stakeholders’  opinions  about  policy  objectives  5,  6  &  7.  This  in  itself  is a 
noteworthy  result,  as  it  suggests  that  EDCTP2  is  not  communicating  enough 
about  its  activities  in  these  fields.  Second,  in  all  three areas, there was a higher 
proportion  of  respondents  sceptical  about  EDCT2’s  success  in  achieving  its 
objectives.  Third,  while  the  share  of  negative  feedback  increased  compared  to 
EDCT2’s  first  four  objectives,  those  respondents  who  provided  positive 
feedback  still  outnumbered  those  who  gave  negative  feedback.  Overall,  due  to 
the  very  high  share  of  “don’t  knows”,  the  results  for  the  last  three  objectives 
should  be  understood  with  some degree of reservation. Nevertheless, they allow 
for  the  conclusion  that  EDCTP2’s  progress  towards  its  policy  objectives  falls 
into  two  broad  categories:  High  confidence  among  stakeholders  that progress is 
being made towards objectives 1, 2, 3 & 4, and a high degree of uncertainty and 
some scepticism about EDCTP2’s progress towards objectives 5, 6 and 7. These 
results are summarized  below:   

72 

 
 
 
 
 
Progress Towards EDCTP2’s Objectives 

Capacity Strenghtening

84% 

6% 

Cooperation with Sub-Saharan Africa

73% 

4% 

New or Impoved Medical Interventions

84% 

4% 

Guidelines for Improving Use of Existing Medical
Interventions

67% 

6% 

Integration Of National Programmes

39% 

15% 

Cooperation With Public And Private Partners

48% 

10% 

Cooperation With Other European Union Initiatives

22% 

15% 

% of Respondents Perceiving Progress

% of Respondents Perceiving No Progress

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%

Figure 46 – Progress towards EDCTP2’s Objectives   

73 

 
 
 
 
 
 
 
Governance and Management 

Overall,  a  majority  of  58%  of  respondents  rated  EDCTP2’s  governance  and 
management  as  either  “very  good”  or  “good”,  as  opposed  to  11%  who  gave  a 
rating  of  “poor”  or  “very  poor”.  19%  of  survey  participants  rated  EDCTP2’s 
management  as  “fair”.  Broken  down 
individual  governance  and 
management activities,  stakeholders’  opinions  fall  into  three distinct  groups.   

into 

The  components  in  the  first  group  received  the  highest  share  of  positive 
feedback  and  either  no  or  only  very  few  negative  mentions  in  answers  to  the 
open  questions.  Overall,  survey  participants  expressed  confidence  in  these 
aspects of EDCTP2’s governance and management:   

1.  Funding  mechanisms  for clinical  trials  research 
2.  Funding  mechanisms  for capacity building  activities 

The  second  group  was  marked  by  somewhat  less  decidedly  positive  feedback 
and  the  qualitative  analysis  revealed  a  higher  share  of  criticism  in  the  open 
questions:   

3.  Setting  of Funding  Priorities 
4.  Conflict  of interest prevention   

The third group is composed of those components that received the lowest share 
of  positive  feedback  in  the  quantitative  analysis  and  the  highest  share  of 
negative  feedback in the qualitative  analysis:   

5.  Proposal submission  and grant management  tools 
6.  Proposal evaluation  and selection 

EDCTP2’s grant management and proposal submission processes were the most 
cited  weaknesses  in  respondents’  answers  to  open  questions  and  EDCTP2’s 
proposal  evaluation  and  selection  received  the  most  unfavourable  feedback  in 
the  quantitative  analysis  with  a  quarter  of  respondents  rating its activities in this 
area  as  either  “poor”  or “very poor”. While there was still a relative majority of 
survey  participants  (42%)  that  rated  EDCTP2’s  proposal  evaluation  and 
selection  positively,  the  high  proportion  of  negative  feedback  (25%)  combined 
with  the  23%  of  respondents  who  complained  about  the  inferior  quality  of 
EDCTP2’s  grant  management  and  proposal  submission  processes  in  the  open 

74 

 
 
 
 
 
 
questions 
opportunities  for improvement  in the future.   

suggests 

that 

these  components  offer 

the  most  significant 

Overall Assessment and Recommendations 

The questionnaires’  final  section asked respondents to cite both EDCTP2’s key 
strengths and weaknesses. The four most cited key strengths were:  

-  Capacity  building  activities  (e.g.  investments  in  skill-building  measures, 

an increased number  of fellowships)     

-  Broadening  of  EDCTP2’s  disease  scope  to  include  poverty-related  and 

neglected diseases (PRNDs) 

-  Facilitation  of  health  research  cooperation  across  sub-Saharan  Africa 

and between Europe and Africa  

-  Calls  for diagnostic  products 

The four most cited weaknesses were: 

- 

Inferior  quality  of  EDCTP2’s  grant  management  and  proposal 
submission  processes.  (including  criticisms  about  the  grant  submission 
process  being  too  slow  and  laborious,  frequent  delays  and  changes  of 
deadlines  and the quality  of reviews)  

-  Evaluation  process  is  insufficiently  transparent.  (Including  demands  for 
more  transparency  when  it  comes  to  the  selection  of  funding  priorities, 
the  process  through  which  funding  decisions  are  made and the reporting 
of conflicts  of interest)   

-  Lack of cooperation  with third  parties   

-  Late  publication  of  the  strategic  business  plan  and  the  annual  work 

plans,  making  it difficult  for applicants  to plan  ahead  

75 

 
 
 
 
 
 
10.  APPENDICES   

10.1. 

Appendix A – Extended Methodological Note  

The  following  appendix  provides  a  detailed  overview  of  the  questionnaire’s 
different  sections,  groups  of  questions  and  the  ranges  of  answers  that  were 
available  to stakeholders  when completing  the questionnaire.   

Section 1: Respondent Profile  

Respondents  were  asked  to  provide  their  name,  e-mail  address,  as  well  as  the 
name  of  their  organisation.  Respondents  were  then  asked  to  categorise  their 
organisation  as  ‘government  administration’;  ‘non-governmental  organisation’; 
‘Inter-governmental  organisation  (e.g.  African  Union  Commission,  World 
Health  Organization)’;  ‘large  pharmaceutical  company’;  ‘small  or  medium-
sized  enterprise  (SME  ≤  annual turnover of € 50 m; and staff of ≤ 250)’; ‘other 
for-profit  organisation  (e.g.  consultancies)’;  ‘private  non-profit  organisation’;  or 
‘university  /  research  institute’.  Respondents  were  also  asked  about  their 
nationality  and  where  geographically  their  organisations  are  based.  They  were 
then  asked  about  the  nature of their involvement with the EDCTP2 programme. 
Here respondents were given the following  options  (multiple  sections possible):   

 
 
 

I am a member of the EDCTP Scientific  Advisory  Committee 
I am a member of the EDCTP General Assembly 
I/my organisation  has applied  for funding  from EDCTP1 and/or 
EDCTP2  
I/my organisation  has been funded by EDCTP1 and/or EDCTP2 

 
  No involvement 
  Other type of involvement  (respondents  were asked to specify).   

Section 2: Advocacy and Communication  

Questions  2.1-2.6  

The  range  of  answers  was  ‘Agree’,  ‘Disagree’,  and  ‘Don't  know’.  These 
questions  asked  respondents  about  their  overall  impression  of  EDCTP2’s 
advocacy  and  communication  activities,  EDCTP2’s  relevance  and  visibility  for 
different  groups  of  stakeholders  and  regions,  and  EDCTP2's  contribution 
towards  expanding  and  strengthening  relationships  between  countries  in  sub-
Saharan Africa and in Europe.   

Question  2.7  

76 

 
 
 
 
This  question  asks  the  respondent  to  rate  the  quality  of  EDCTP2's  different 
communication  activities  on  a  scale  of  1-5  (1=very  poor;  2=poor;3=fair;4= 
good;5=very  good).  For  each  of 
the  communication  activities  that  the 
respondent  is  asked  to  rate,  he  or  she  also  has  the  option  to  answer  ‘Don’t 
know.’ 

Section 3: Progress towards EDCTP2’s Objectives  

Questions  3.1-3.5 

The  range  of  answers  was  ‘Agree’,  ‘Disagree’,  and  ‘Don't  know.’  If 
respondents  selected  the  option  ‘disagree’  for  question  3.5  (The  funding 
priorities  of  the  EDCTP2  programme  reflect  the needs  of  sub-Saharan  African 
countries),  they were asked to briefly  explain  why.  

Questions  3.6-3.7 

The  range  of  answers  was  ‘Yes’,  ‘No’,  and  ‘Don’t  know.’  If  respondents 
selected  ‘yes’,  they  were  asked  to  cite  examples  of  activities  carried out in the 
context  of  EDCTP2  that  led  to  cooperation  with  other  public or private funders 
or other European Union  initiatives.   

Question  3.8 

This  questions  asked  respondents  to  rate  EDCTP2's  activities  to  strengthen 
cooperation  between  European  and sub-Saharan African countries on a scale of 
scale  of  1-5  (1=very  poor;  2=poor;3=fair;4=  good;5=very  good).  The  question 
also provided  respondents with  the option  to select ‘Don’t know’.   

Section 4: Governance and Management 

Questions  4.1-4.7 

These  questions  were  directed  at  assessing  stakeholder’s  opinions  of  the 
governance  and  management  of  the  EDCTP2  programme.  Respondents  were 
asked  to  rate  different  aspects  of      the  governance  and  management  of  the 
EDCTP2  programme  on  a  scale  of  1-5  (1=very  poor;  2=poor;3=fair;4= 
good;5=very  good). Each question  also included  the option  ‘Don’t know.’ 

asked 

respondents 

Question  4.8 
of 
This 
questions 
recommendations  from 
the  2009  evaluation  of  EDCTP1.  For  reference 
purposes,  respondents  were  provided  with  a  link  to  the  2009  Evaluation  Report 
of  EDCTP1.  The  range  of  answers  was  ‘Yes’,  ‘No’,  and  ‘Don’t  know.’  If 
respondents  selected  ‘Yes’,  they  were  asked  to  cite  one  example  of  a  change 
that was made based on recommendations  from this  previous  evaluation.   

implementation 

about 

the 

77 

 
 
 
 
 
 
Section 5: Overall Assessment and Recommendations 

This  section  consisted  of  three  open  questions  and  asked  respondents to assess 
the  EDCTP2  programme  in  terms  of  key  strengths (5.1), weaknesses (5.2) and 
to  provide  specific  recommendations  about  the  future  direction  of  the  EDCTP2 
programme  (5.3).  

Data Extraction  

The responses to the questionnaire  were extracted via the EU Survey tool  on 17 
November 2016.  In total 67 participants  answered the questionnaire.     

Open Questions  

The following  questions  were open questions  requiring  qualitative  analysis   

1.  Question  3.5:  the  funding  priorities  of  the  EDCTP2  programme  reflect 
the needs  of  sub-Saharan  African  countries).  In  case  of  disagreement 
briefly  explain  why.  

2.  Question  3.6:  As  far  as  you know, have joint calls and/or other activities 
with public  and  private  funders  been  launched  under  the  EDCTP2 
programme?  In  case  of  “yes”,  respondents  were  asked  to  cite  an 
example   

3.  Question  3.7:  As  far  as  you  know,  have  actions  been  taken  under 
the EDCTP2  programme 
impact  by  effectively 
increase 
cooperating  with  other  relevant  European  Union  initiatives,  including  its 
development  assistance  programmes?  In  case  of  “yes”,  respondents 
were  asked  to  cite  an  example  of  how  EDCTP2  has  cooperated  with 
other European Union  initiatives. 

its 

to 

4.  Question  4.8: As far as you know, have recommendations from the 2009 
evaluation of  EDCTP1  been  successfully  implemented?  If  respondents 
selected ‘Yes’, they were asked to cite one example of a change that was 
made based on recommendations  from this  previous  evaluation.   

5.  Question  5.1:  Please  assess  the  EDCTP2  programme  during  the  period 

2014-2016  in terms of key strengths.   

6.  Question  5.2:  Please  assess  the  EDCTP2  programme  during  the  period 
2014-2016  in terms of weaknesses or opportunities  for improvement. 

78 

 
 
 
 
 
 
 
 
 
 
7.  Question  5.3:  Please  provide  specific  recommendations  about  the  future 

direction  of the EDCTP2 programme.    

Results Divided by Category of Respondent  

The largest group of survey participants were stakeholders that have either been 
funded  by  EDCTP1  or  EDCTP2  in  the  past  or  have  applied  for  funding  from 
EDCTP1  or EDCTP2. These stakeholders form the category “funded or applied 
for  funding”.  The  second  largest  group  of  respondents  described  some  other 
type  of  involvement  with  EDCTP1  or  EDCTP2.  All  of  these respondents were 
grouped  together  to  form  the  category  “other  type  of  involvement”.  The  third 
largest  group  were  members  of  the  EDCTP  General  Assembly,  followed  by 
respondents  who  had  no  prior  direct  involvement  with  EDCTP1  or  EDCTP2, 
which  were  classified  as  “no  involvement”.  Finally,  among  the  stakeholders 
was  one  respondent  from  EDCTP2’s  Scientific  Advisory  Committee,  classified 
as “member of the SAC.”  
A  number  of  questions  was  selected  for  a  more  detailed  analysis  by 
respondents’  type  of  involvement  in  order  to  examine  whether  “type  of 
involvement”  had  a  significant  effect  on  how  respondents  replied  to  the 
questionnaire  and  to  describe  any  patterns  or  biases  if  found.  The  questions 
were  taken  from  the  following  sections:  advocacy  and  communication, progress 
towards  EDCTP2’s  objectives  and  governance  and  management. The following 
two  questions  were  analysed  by  respondents’  geographic  location  (Europe  or 
sub-Saharan  Africa),  again  with  the  goal  to  detect  possible  biases  where 
relevant:   

-  How would  you rate EDCTP2's activities  to strengthen cooperation 
between European and sub-Saharan African countries? (positive  / 
neutral / negative  / don’t know) 

-  The funding  priorities  of EDCTP2 reflect the needs of sub-Saharan 

African countries. (agree / disagree / don’t know)   

- 

The questions  that were analysed along  these lines  were selected for a number 
of criteria (e.g. importance,  large share of respondents  replied  “don’t  know”, 
suspicion  of bias)   

79 

 
 
 
 
 
 
 
 
 
 
 
10.2. 

Appendix B – Survey Questionnaire  

"Public  Consultation  on  the  Implementation  of  the  Second  European  and 
Developing  Countries  Clinical  Trials  Partnership during  the period  2014-2016" 

Introduction 

This  questionnaire  is  part  of  an  interim  evaluation  of  the  implementation  of  the 
second  European  and  Developing  Countries  Clinical  Trials  Partnership 
(EDCTP2).  The  European  Commission  is  conducting  this  evaluation  in  order  to 
develop  recommendations  about  the  future  direction  of  the  programme.  The 
results  of  the  evaluation  will  also  be  included  in  the  interim  evaluation  of  the 
EU's overall  research programme Horizon  2020. 

The  purpose  of  this  questionnaire  is  to  gather  views  from  a  variety  of 
stakeholders  on  the  first  three  years  (2014-2016)  of  the  implementation  of  the 
EDCTP2  programme.  The  objective  of  the  interim  evaluation  is  to  assess  the 
implementation  of  EDCTP2  up  to  the  present  moment;  to  judge  how 
recommendations  from  previous  evaluations  have  been  implemented;  and  to 
provide  an  outlook  on  what  can  be  expected  from  EDCTP2  in  the  future.  The 
success  of  this  evaluation  is  to  a  large  extent  dependent  upon  the  data, 
information  and  feedback  we  are  able  to  gather  among  stakeholders  of  the 
EDCTP2  programme.  Your  input  and  opinion  are  of  great  value  to  the  project 
and  the  future  of  EDCTP2,  therefore  we  would  be  very  grateful  if  you  could 
take some time  to fill  in  this short questionnaire. 

The survey takes about 15 minutes  and includes  the following  sections: 

  Personal Information 
  External  Communication  and Advocacy 
  Progress towards EDCTP2's Objectives 
  Governance and Management 
  Recommendations  to improve  performance of the programme 

Do  you  agree  to  your  contribution  being  published  under  your  name  or  the 
name of your  organisation? 

 
 

 

I want my contribution  to be published  under my name 
I  want  my  contribution  to  be  published  under  the  name  of  my 
organisation 
I want my contribution  to be published  anonymously 

80 

 
 
 
 
 
 
 
 

I do not want my contribution  to be published 

Your  contribution  consists  of  your  response  to  questions  where  you  choose  to 
give  written  feedback, as well as your response to the final two questions of the 
survey,  where  you  have  the  opportunity  to  comment  on  the  strengths  and 
weaknesses  of  the EDCTP2 programme. If you do consent to the publication of 
your  contribution,  it  will  be  included  in  the  final  report  on  this  public 
consultation  either  under  your  name,  the  name  of  your  organisation  or 
anonymously.  The  final  report  will  be  made  publicly  accessible  on  the 
European Commission website. Your personal data and replies are recorded in a 
secured  and  protected  database  hosted  by  the  Data  Centre  of  the  European 
Commission.  The  information  provided  by  you  will  remain  in  the  database  until 
the results have been analysed or until one year after the end of the consultation. 
Note  that  whatever  option  is  chosen,  your  contribution  may  still  be  subject  to 
requests for ‘access to documents’ under Regulation  1049/2001.   

In  the  interests  of  transparency,  organisations  are  invited  to  provide  the  public 
with  relevant  information  about  themselves  by  registering  in  the  Interest 
Representative  Register  and  subscribing  to  its  Code  of  Conduct.  If  the 
organisation  is  not  registered,  the  submission  is  published  separately  from  the 
registered organisations. 

Background Information on EDCTP2 

The  first  European  and  Developing  Countries  Clinical  Trials  Partnership 
(EDCTP)  programme  was  launched  in  2003  by  the  European  Union  (EU)  and 
15 EU Member States in response to the global health crisis caused by the three 
main  poverty-related  diseases:  HIV/AIDS,  malaria  and  tuberculosis.  This  was 
done  with  the  aim  to  accelerate  the  development  of  new  or  improved  drugs, 
vaccines,  microbicides  and  diagnostics  for  these  diseases.  In  its  approach  the 
programme  focused  on  clinical  trials  in  sub-Saharan  Africa.  Following  the 
success  of  the  first  EDCTP  programme,  the  EU  decided  in  2014  to  extend  its 
commitment  to  this  strategic  partnership  and  increase  its  contribution  from 
EUR  200  million  to  EUR  683  million  in  the  second  programme  (EDCTP2, 
2014-2024). 

The  general  objective  of  the  EDCTP2  programme  is  to  contribute  to  the 
reduction  of  the  social  and  economic  burden  of  poverty-related  diseases  in 
developing  countries,  in  particular  in  sub-Saharan  Africa,  by  accelerating  the 

81 

 
 
 
 
 
 
 
clinical  development  of  effective,  safe,  accessible,  suitable  and  affordable 
medical  interventions  for  poverty-related  and  neglected  diseases  in  partnership 
with countries  in  sub-Saharan Africa. 

Section 1: Personal Information 

Please enter your name: 
Please enter your e-mail  address: 
Please enter the name of your organisation: 
At what type of organisation  do you work (or study)? 

  Government  administration 
  Non-governmental  organisation 
 
  Large pharmaceutical  company 
  Small  or medium-sized  enterprise (SME ≤ annual  turnover of € 50 m; 

Inter-governmental  organisation  (e.g. AUC, WHO) 

and staff of ≤ 250) 

  Other for-profit  organisation  (e.g. consultancies) 
  Private non-profit  organisation   
  University  / research institute 

Where is your  organisation  based? 

What  is  the  nature  of  your  involvement  with  EDCTP2?  (Multiple  selections 
possible) 
 
 
 

I am a member of the EDCTP2 Scientific  Advisory  Group 
I am a member of the EDCTP2 General Assembly 
I/my organisation  has applied  for funding  from EDCTP1 and/or 
EDCTP2 
I/my organisation  has been funded by EDCTP1 (2003-2013)  and/or 
EDCTP2 (2014-2016) 

 

  No involvement 
  Other type of involvement,   

What is your nationality? 

82 

 
 
 
 
 
 
 
 
 
 
 
Section 2: Communication and Advocacy 

Please indicate your agreement with the following statements about EDCTP2's 
advocacy and external communication efforts. 

Overall,  EDCTP2's communication  activities  are relevant and of good  quality. 

  Agree 
  Disagree 
  Don't know 

EDCTP2's  advocacy  efforts  contributed  to  expand  and  strengthen  relationships 
between countries in  sub-Saharan Africa and in  Europe 

  Agree 
  Disagree 
  Don't know 

EDCTP2  is  a  relevant  and  visible  initiative  for  the  global  health  research 
community  worldwide. 

  Agree 
  Disagree 
  Don't know 

EDCTP2  is  a  relevant  and  visible  initiative  for  health  researchers  in  sub-
Saharan Africa.  
  Agree 
  Disagree 
  Don't know 

EDCTP2  is  a  relevant  and  visible  initiative  other  public  health  stakeholders  in 
Africa. 

  Agree 
  Disagree 
  Don't know 

EDCTP2 is a relevant and visible  initiative  for health  researchers in Europe.  

  Agree 
  Disagree 
  Don't know 

In your opinion,  how would  you rate the quality  of EDCTP2's different 
communication  efforts?  
(very good/good/fair/poor/very  poor) 

83 

 
 
 
 
 
 
Website 
Call  announcements 
Applicant/grantee  support 
Stakeholder  meetings 
The EDCTP forum 
Newsletters 
Annual  reports 

Section  3:  Progress  towards  the  Objectives  of  the  EDCTP2 
Programme 

Please indicate your agreement with the following statements about EDCTP2's 
progress towards its overall objectives. 

EDCTP2  is  contributing  to  strengthening  the  capacity  of  sub-Saharan  African 
countries  to conduct clinical  trials. 

  Agree 
  Disagree 
  Don't know 

EDCTP2  is  contributing  to  the  integration  of  national  European  programmes 
and  has 
the  cost-effectiveness  of  European  public 
investments. 

increased 

thereby 

  Agree 
  Disagree 
  Don't know 

EDCTP2  is  contributing  to  increasing  the  number  of  new  or  improved  medical 
interventions  for  HIV/AIDS,  tuberculosis,  malaria  and  other  poverty-related 
and neglected  diseases. 

  Agree 
  Disagree 
  Don't know 

EDCTP2  is  contributing  to  the  development  of  guidelines  for  improving  or 
extending  the use of existing  medical  interventions. 

  Agree 
  Disagree 

84 

 
 
 
 
 
 
 
 
  Don't know 

The  funding  priorities  of  EDCTP2  reflect  the  needs  of  sub-Saharan  African 
countries.  

  Agree 
  Disagree 
  Don't know 

If you selected disagree,  please briefly  explain  why. 

As  far  as  you  know,  have  joint  calls  and/or  other  activities  with  public  and 
private funders been launched  under the EDCTP2 programme?   

  Yes 
  No 
  Don't know 

If you selected yes, please cite one example of a how EDCTP2 has worked with 
other public  or private funders. 

As  far  as  you  know,  has  EDCTP2  taken  actions  to  increase  its  impact  by 
initiatives, 
effectively  cooperating  with  other 
including  its development  assistance programmes? 

relevant  European  Union 

  Yes 
  No 
  Don't know 

If  you  selected  yes, please cite one example of a how EDCTP2 has cooperated 
with other European Union  initiatives. 

In  your  opinion,  how  would  you  rate  EDCTP2's  activities  to  strengthen 
cooperation  between European and sub-Saharan African countries? 
(very good/good/fair/poor/very  poor) 

85 

 
 
 
 
 
 
 
 
 
Section  4:  Governance  and  Management  of  the  EDCTP2 
Programme 

Overall,  how  would  you  rate  the  management  and  execution  of  the  EDCTP2 
programme? 
(very good/good/fair/poor/very  poor) 

Overall,  how  would  you  rate  the  strategy  and  processes  for  setting  EDCTP2’s 
funding  priorities? 
(very good/good/fair/poor/very  poor) 

In  your  opinion,  how  would  you  rate  EDCTP2's  funding mechanisms to support 
clinical  trials  research in sub-Saharan Africa? 
(very good/good/fair/poor/very  poor) 

In  your  opinion,  how  would  you  rate  EDCTP2's  funding  mechanisms  to 
strengthen  the  capacities  of  sub-Saharan  African  countries  to  conduct  clinical 
trials? 
(very good/good/fair/poor/very  poor) 

In  your  opinion,  how  would  you  rate  the quality and transparency of EDCTP2's 
proposal  evaluation  and selection  process? 
(very good/good/fair/poor/very  poor) 

In  your  opinion,  how  would  you  rate  the  effectiveness  of  EDCTP2's  proposal 
submission  and grant management  tools? 
(very good/good/fair/poor/very  poor) 

In  your  opinion,  how  would  you  rate  the  effectiveness  of  EDCTP2's policies to 
prevent conflicts  of interest? 
(very good/good/fair/poor/very  poor) 

As  far  as  you  know,  have  recommendations  from  the  2009  evaluation  of 
EDCTP1  been successfully implemented? (For reference purposes, you can find 
the 2009  Evaluation  Report of EDCTP1 here.) 

  Yes 
  No 
  Don't know 

86 

 
 
 
 
 
 
 
 
 
 
If you selected yes, please cite one example of a change that was made based on 
recommendations  from previous  evaluations. 

Section 5: Overall Assessment and Recommendations  

Please  assess  the  EDCTP2  programme during the period 2014-2016 in terms of 
key strengths: 

Please  assess  the  EDCTP2  programme during the period 2014-2016 in terms of 
weaknesses or opportunities  for improvement: 

Please  provide  specific  recommendations  about  the  future  direction  of  the 
EDCTP2 programme: 

Final remarks 

Thank you very much for participating  in this survey. 
If  you  have  any  questions  regarding  this  survey,  please  do  not  hesitate  to 
contact us at: 

RTD-INFECTIOUS-DISEASES-PUBLIC-HEALTH@ec.europa.eu 

Legal basis of the interim evaluation of the EDCTP2 prog ramme  

In accordance with EU decision 556/2014, the European Commission has to 
carry out, with the assistance of independent experts, an interim evaluation of 
the  EDCTP2  programme  by  30  June  2017.  It  further  specifies  that  the 
European  Commission  has  to  deliver  a  report  on  the  EDCTP2  interim 
evaluation  to  the European Parliament and to the Council by 31 December 
2017.  EU  decision 556/2014 and all related legal documents, on which the 
EDCTP2 Programme is based can be found at http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32014D0556&from=EN. 

87 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.3. 

Appendix C – Desk Review Documents  

1.  EU  Decision  556/2014  on  the  participation  of  the  Union  in  a  second 
European  and  Developing  Countries  Clinical  Trials  Partnership  Programme 
(EDCTP2) jointly  undertaken by several Member States  

2.  Regulation  (EU)  1291/2013  establishing  Horizon  2020  -  the  Framework 
Programme for Research and Innovation  (2014-2020) 

3.  Independent  external  evaluation  report  of  the  European  and  Developing 
Countries  clinical  Trials  Partnership  (EDCTP)  programme  of  14  December 
2009   

4.  Assessment  of  the  need  for  a  renewed  European  and  Developing  Countries 
Clinical  Trial  Partnership  (EDCTP)  initiative  -  Analysis  of  Results  from  the 
Public  Consultation  (2012)  

5.  European  and  Developing  Countries  Clinical  Trials  Partnership  Programme 
(EDCTP2) Annual  Work Plan 2016  – 15 June 2016   

6.  Assessment  of  the  performance  and  impact  of  the  first  programme  of  the 
European  &  Developing  Countries  Clinical  Trials  Partnership  (EDCTP)  (2014) 

88 

 
 
 
  
 
 
 
 
 
K
I
-
0
4
-
1
7
-
8
4
6
-
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]

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e

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]

Within  the  context  of  the  first  interim  evaluation  of  the  second  European  & 
Developing  Countries  Clinical  Trials  Partnership  (EDCTP2)  programme,  a 
public  consultation  was 
launched.  An  electronic  survey  was  published 
addressed  to  stakeholders  of  the programme  in order to assess  their perceptions 
about  EDCTP2’s  progress  towards  achieving  its  objectives.  The  consultation 
was  open  for  four  and  a  half  months  however,  despite  significant  efforts 
undertaken  to  promote  the  questionnaire,  –  only  67  responses  were  received. 
This  low  number  of  responses  imposes  a  significant  limitation  when  analysing 
the results obtained. 

doi: 10.2777/26359