Correspondence

Global Health & Medicine. 2023; 5(2):118-121.
DOI: 10.35772/ghm.2023.01004

Evolving partnership: A National Center for Global Health andMedicine Resilient Training Model for clinical research professionals
during the COVID-19 pandemic
Sifa Marie Joelle Muchanga*, Mieko Hamana, Marlinang Diarta Siburian, Maria Ruriko Umano, Nattha Kerdsakundee,
Maria Rejane Umano, Masato Ichikawa, Tatsuo Iiyama
Department of International Trials, National Center for Global Health and Medicine, Tokyo, Japan.

Abstract: The clinical trial industry has encountered challenging circumstances in which the increasing number oftrials outpaces the number of trial specialists. For instance, there has been an unprecedented demand for clinical trials
following the Covid-19 pandemic, which has worsened the global shortage of qualified personnel. It is therefore
imperative to produce more qualified clinical trial professionals. An adaptive and collaborative training model wasimplemented by the National Center for Global Health and Medicine through the Department of International Trials.
This aimed at building capacity among health workers in developing countries and providing them with the skills tobe able to conduct all phases of the clinical trial from protocol design to publication of results. It also seeks to foster
collaboration and partnership between local health workers and international experts. Since 2016, we have implemented
a Japan-led training program, and since 2020, the COVID-19 pandemic has ushered in a shift from a single Train-thetrainer model (ToT) to a mixed model, the Evolving Partnership Training (ePT). In this model, we applied four different
methods: train-the-trainer, needs-oriented training, open symposiums, and advanced learning. The total number oftraining participants increased exponentially from a total of 41 between 2016–2020 to 2,810 in 2021. Our experiencehas proven that despite the constraint of the pandemic, the ePT is a viable approach compared to a single method forproviding quality training and increasing the number of participants.
Keywords: clinical trial professionals, evolving partnership training, National Center for Global Health andMedicine, training, train-the-trainer

The number and complexity of clinical trials has
been increasing while the number of clinical trials
professionals has not evolved in an equivalent way (1).
Records from the WHO International Clinical Trials
Registry Platform (ICTRP) that include observational
and interventional studies compiled from different
registries, had shown a continuous increase in numberof registered studies all over the WHO regions since1999 (2).
For example, on December19 th, 2022 a total of
436,709 studies have been registered on ClinicalTrials.
gov reporting a very steady increase with the adventof COVID-19 that accounts for 8,522 studies (3).
In parallel, a global concern is raising the problemof shortage of clinical research professionals in all
categories combined (4,5). This shortage was reportedat 15% before the COVID-19 pandemic but has almost
doubled to 29% during the post-pandemic period. Sucha shortage may alter the proper functioning of clinicalresearch operations (6).
According to the United States Food and Drug

Administration (USFDA), only 3% of physicians
and patients took part in a clinical trial that leads to
new therapies and the majority were conducted at top
academic institutions limiting the coverage of large
proportion of the population (7). Only few professionals
enter the clinical research industry with qualifications
directly from the university (1). Medical schoolcurricula allocate less time to educate students about
the significance of biomedical research for better healthcare or to attract students to participate in biomedical
research (8). In addition, the majority of clinicians do
not receive enough exposure to research methods aspart of their clinical development. Even fewer cliniciansreceive exposure to regulatory processes training, whichis part of the core competency for clinicians who areinvolved in trials heading for regulatory approval (1).
Furthermore, the onset of the COVID-19 pandemic
revealed to the world how weak health systems wereand how little prepared both research communities
and governments were for a possible health disaster.
Moreover, we are not spared by the occurrence of a(118)Global Health & Medicine. 2023; 5(2):118-121.

www.globalhealthmedicine.com

pandemic X in the future (9).
The International Council for Harmonisation ofTechnical Requirements for Pharmaceuticals for Human
Use (ICH) E6-R2 (Good Clinical Practice) repeatedly
mentions that each trial personnel "should be qualified
by education, training and experience to performtasks" (10). It is thus, of high interest to participate inthe global efforts of filling the gap that is faced by theclinical research professional community.
Through the Department of International Trials,
the National Center for Global Health and Medicine(NCGM), has been committed to improve access tohealthcare by promoting international clinical research/trials between Japan and partners in Asian and Africancountries.
From 2016 to 2020, we funded and implemented anannual training program using the training of trainers(ToT) model, during which topics related to clinical
trials design and operations were discussed. Delegatesfrom Democratic Republic of the Congo, Indonesia,
Philippines, Thailand, Vietnam, and Japan joined a
2-week intensive short training program and participatedas observer at the multiregional clinical trials seminarorganized annually by the Japan Pharmaceutical andMedical Device Agency (PMDA). In order to evaluate
the learning comprehension of the participants, pre-tests
and post-tests were administered. In addition, all training
materials were distributed to them, for their reference.
Trainees were required to obtain a minimum of 80 % on
the final evaluation test.
With the advent of the COVID-19 pandemic, global
movements were restricted and face to face meetings ofparticipants from different countries had become nearly
impossible. In collaboration with past trainees, wethen developed a new capacity building model which
consisted of three pillars in addition to the ToT; first aneeds-customized local training, second an advanced
e-learning and third an international online symposium.
We named the model as the evolving partnershiptraining (ePT) model.
Regarding the needs-customized local training,
contents were developed after consultation with pasttrainees and their supervisors to pin out training needsin their working environment. Each collaborating
institution implemented trainings in their setting with afocus on particular topics related to their self-assessed
local needs. Theses local trainings were conducted either
by face to face, online or hybrid.
From the locally trained participants, 30 wereselected to participate in the advanced e-learning
program for principal investigators that included six main
topics, pre-clinical studies, regulation for clinical trials,
epidemiology, biostatistics for clinical research, data
management and translational medicine. For the current
training, we developed the content in collaboration with
Chiba University and St Luke's University; Japaneseexperts were invited to provide the lectures.

As for the symposium, it is being carried out
annually and involves key opinion leaders from various
developed and developing countries who share theirexpertise on selected aspects of clinical trials. Figure 1
illustrates the mathematical model and components ofthe program.
In total, there were 41 trainees composed ofphysicians and statisticians who joined the ToT programin Tokyo from 2016 to 2020 ‒ 6 in 2016, 8 in 2018, 14in 2019, and 13 in 2020. In 2021, when the ePT wasintroduced, 2,810 professionals were trained locally intheir respective countries by joining the local training,
the e-learning and the online symposium as shown in theFigure 2.
The present training model, was a concept
developed from the concept starting by a one-way
ToT to a participative multilateral collaboration that
could improve both the quality and the number oftrained professionals. This illustrates that not only thefunder gives his own orientation but also the learners
by defining their needs, have active involvement in
the implementation of the program. Participative
collaboration in the program design is of great value
because the training meets the learners self-assessedneeds. We could observe an exponential increase in
the number and quality of participants in the training
program.
The ePT model is partially closer to the Analyze,
Design, Develop, Implementation and Evaluate(ADDIE) (11) and to the ToT models (12). In fact, thefirst pillar of the ePT that consisted of the one-way
training resulted in training of professionals able to trainothers in their individual settings. The second pillar
that consisted of the local needs-customized training

Figure 1. The evolving partnership training model (ePT).
The ePT model includes the training of trainers, the needcustomized, the advanced e-learning course and the opensymposium. The needs-customized trainings were conducted
either as: lecture type X2', webinar and conference X2'',
or Discussion forum X2'''). α: Initiating Institution; β :Collaborative institution; X: Learning types; X1: training thetrainers (ToT) course; X2: Needs – customized course (X2':lecture type; X2'': webinar, conference; X2''': Discussionforum); X3: Advanced e-learning course; X4: Opensymposium; Y: number of trainees.

(119)Global Health & Medicine. 2023; 5(2):118-121.

www.globalhealthmedicine.com

ePT is a viable approach other than a single method forproviding quality training and increasing the number ofparticipants. This model should be one of the solutions,to participate in the global effort for capacity buildingof clinical trial professionals.
Acknowledgements

Figure 2. Distribution of training participants per country
and per fiscal year. Participants from six countries joined theannual training program lead by the National Center for Global
Health and Medicine. The number of participants has gradually
increased over time with a remarkable increase in 2021 during
the COVID-19 pandemic. Note: the scale is different in 2021.

program is similar to the ADDIE model in terms ofanalyzing the learner's needs and knowledge before
designing and producing the content of the training.
For the ADDIE model, before starting to develop
a course, you need to do the training needs assessmentthat would be the basis for the other steps of theimplementation of the training and evaluation of theoutcome. The difference is that in the ADDIE model
the analyses are one-way from the trainers while in theePT model, there are 2 layers of trainers that collegiallydevelop the content of the training. However, the ePTmodel does not evaluate the outcome of the training as
a whole but each of the ePT components were evaluatedseparately.
The ePT model is considered to be a mixed modelthat includes part of ADDIE and ToT, in addition to themultilateral involvement in the design of the content.
The added value of the current training model is that theprogram is needs-oriented, cost-effective and involves
partnership in design.
The limitation of the current model, is that we did
not evaluate the outcome of the training as a wholein terms of the quality of trained professionals but
one should assume that based on the content of theprogram and the motivation of learners, the programis worthwhile to have been implemented. Anotherlimitation is that the content was not uniform for all theparticipants involved in the program, however, a needscustomized content is more valuable to solve real timeissues faced by the learners to bring the solution to thelocals by the locals. We assume that this component of
the ePT motivates the participants to take ownership in
finding solutions to their perceived problems in theirresearch environment.
In conclusion, the current study has evidenced that
despite the constraint of the COVID-19 pandemic, theWe thank all the participants to the training and partner
Institutes and Universities for collaborating in theimplementation of the training program. The following
research institutions participated in the program: The
Universitas Indonesia, University of the Philippines
Manila, University of Kinshasa, Siriraj Institute ofClinical Research, and Bach Mai Hospital. We also
thank all the trainers for sharing their knowledge.
Funding: The training program has been funded by theJapan Agency for Medical Research and Development(AMED). (Project Name: Clinical research platformformation to promote international research cooperation
between Japan and Asian countries in the field of
infectious diseases, AMED 20lk020100j0001).
Conflict of Interest: The authors have no conflicts ofinterest to disclose.
References
1.
2.

3.
4.

5.
6.

7.

8.

(120)

Sonstein SA, Jones CT. Joint task force for clinical trial
competency and clinical research professional workforcedevelopment. Front Pharmacol. 2018; 9:1148.
World Health Organisation. Number of clinical trials byyear, country, WHO region and income group (19992021). https://www.who.int/observatories/globalobservatory-on-health-research-and-development/
monitoring/number-of-clinical-trials-by-year-countrywho-region-and-income-group (accessd December 19,2022).
Clinical Trials.gov. Trends, Charts, and Maps ClinicalTrials.gov https://clinicaltrials.gov/ct2/resources/
trends (accessd December 19, 2022).
Alsumidaie M. Entry level CRA Shortage Still Crippling
Clinical Trials. https://www.appliedclinicaltrialsonline.
com/view/entry-level-cra-shortage-still-crippling-clinicaltrials (accessd December 10, 2022).
Numerous Challenges Create Clinical Research Crisis.
Cancer Discovery. 2022; 12:OF2-OF2.
Knapke JM, Snyder DC, Carter K, Fitz-Gerald MB, Fritter
J, Kolb HR, Marchant M, Mendell A, Petty M, Pullum C,
Jones CT. Issues for recruitment and retention of clinicalresearch professionals at academic medical centers: Part 1- collaborative conversations Un-Meeting findings. J Clin
Transl Sci. 2022; 6:e80.
Health2047. "Trial-In-A-Box" to help more practices
take part in clinical trials. https://health2047.com/media_
coverage/trial-in-a-box-to-help-more-practices-take-partin-clinical-trials/ (accessd December 1, 2022).
Mitchell EJ, Goodman K, Wakefield N, Cochran C,
Cockayne S, Connolly S, Desai R, Hartley S, Lawton SA,
Oatey K, Rhodes S, Savage JS, Taylor J, Youssouf NFJ;Global Health & Medicine. 2023; 5(2):118-121.

www.globalhealthmedicine.com

UK Trial Managers' Network. Clinical trial management:
A profession in crisis? Trials. 2022; 23:357.
9. Tahir MJ, Sawal I, Essar MY, Jabbar A, Ullah I, Ahmed
A. Disease X: A hidden but inevitable creeping danger.
Infect Control Hosp Epidemiol. 2022; 43:1758-1759.
10. ICH Harmonised Guideline. Integrated addendum
to ICHE6(R1): Guideline for Good Clinical PracticeE6(R2). https://database.ich.org/sites/default/files/E6_
R2_Addendum.pdf (accessd November 30, 2022).
11. Branch RM. Instructional Design: The ADDIE Approach.
Springer New York, NY, 2009; pp. 22-56.
12. Center for Disease Control and Prevention. Understanding
the Training of Trainers Model. https://www.cdc.gov/
healthyschools/tths/train_trainers_model.htm (accessdDecember 16, 2022).
---Received January 19, 2023; Revised April 3, 2023; AcceptedApril 7, 2023.
Released online in J-STAGE as advance publication April 12,2023.
*Address correspondence to:
Sifa Marie Joelle Muchanga, Department of International
Trials, National center for Global Health and Medicine, 1-21-1,Toyama, Shinjuku-ku, Tokyo 162-8655, Japan.
E-mail: msifa@hosp.ncgm.go.jp(121)