Source: EURLEX
Language: en
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# 52012SC0201

**COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT ON THE REVISION OF THE 'CLINICAL TRIALS DIRECTIVE' 2001/20/EC Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC**

  

COMMISSION STAFF WORKING DOCUMENT

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT
REPORT ON THE REVISION OF THE 'CLINICAL TRIALS DIRECTIVE' 2001/20/EC

Accompanying the document

Proposal for a Regulation of the
European Parliament and of the Council

on clinical trials on medicinal
products for human use, and repealing Directive 2001/20/EC

1.           Problem Definition

1.           Clinical trials in the
sense of the Clinical Trials Directive are investigations of medicines in
humans where the medicines are applied outside normal clinical practice on the
basis of a research protocol. Applications for marketing authorisation and publications
in medical journals are based on data generated in clinical trials. Therefore,
clinical trials are essential to develop medicinal products and improve medical
treatment.

2.           Clinical trials are
regulated by the Clinical Trials Directive 2001/20/EC. The key aim of the
Directive is to ensure safety and rights of subject, and reliability and
robustness of data generated in a clinical trial.

3.           The Clinical Trials
Directive is criticised by all stakeholders (ranging from patients to
researchers and industry) for having caused a significant decline in the
attractiveness of patient-oriented research and related studies in the EU.
Indeed, the number of clinical trials applied for in the EU has fallen from
5028 (2007) to 4400 in 2010. This trend greatly reduces Europe’s
competitiveness in the field of clinical research and, thus, has a negative
impact on the development of new and innovative treatments and medicines. The
main problems identified relate to the following issues:

4.           Separate submission and
diverging assessments and regulatory follow-up of applications for clinical
trials: Clinical
trials are subject to an authorisation (submission and assessment) and
regulatory follow-up/supervision. The submission, assessment and regulatory
follow-up for the same clinical trial are conducted in the different
Member States completely separate from another. Moreover, within each Member
State, two distinct bodies are involved: the national competent authority (NCA)
and one or more Ethics Committee(s) (EC). This system induces elevated
administrative burdens, and cumbersome hurdles to conduct research with
associated delays of access to innovative, potentially life-saving, treatment.

5.           Greater difficulties with
conducting clinical trials due to regulatory requirements not adapted to
practical considerations and needs: The risk to patient
safety in a clinical trial can vary widely, depending on in particular the extent
of knowledge and prior experience with the medicine which is object of the
clinical trial (the 'investigational medicinal product' ‑ IMP).
It is critical to take into account whether or not the IMP is already authorised
in the EU or elsewhere. However, the Clinical Trials Directive does not
sufficiently address these differences in risk and take them into account. Instead,
the obligations and restrictions laid down in the Directive apply largely irrespectively
of the risk to subject safety and without matching practical considerations and
requirements.

6.           Reliability of clinical
trial data in a globalised research environment: There is a trend towards globalisation
of clinical research, in particular towards emerging economies. Clinical
research on a global scale is of benefit to the countries participating, to their
populations and to global public health. However, the globalisation of clinical
research poses a challenge when it comes to supervision of compliance with good
clinical practice (GCP).

2.           Analysis of subsidiarity

7.           Union legislation on
clinical trials is based on Article 114 of the Treaty on the Functioning of the
European Union (TFEU). Based on Article 114 of the TFEU, the EU exercises a
shared competence.

8.           Harmonised rules open up
the possibility of referring to the results and findings of clinical trials in
applications for an authorisation for placing a medicinal product on the Union
market. This is critically important as practically all larger clinical trials
are often performed in more than one Member State. To address this issue, the
Clinical Trials Directive lays down, at Union level, the exhaustive rules to be
complied with for clinical trials.

9.           While regulation of
clinical trials is compatible with the principle of subsidiarity, there are
limits set by the Treaties which have to be considered when formulating the
policy options: The Treaty sets limits concerning the harmonisation of ethical
aspects (i.e. in particular the need to obtain ‘informed consent’ from the
subject). Moreover, there are several aspects which are of an intrinsically
national nature, such as rules for establishing who is a ‘legal representative’
of a subject and rules on the liability for damages suffered by a subject.

3.           Objectives

·
Objective No 1: A
modern regulatory framework for submission, assessment and regulatory follow-up
of applications for clinical trials, taking into account the multinational research
environment. This means the operational objectives of reducing
administrative burdens and operational costs, and reducing delays for the
launch of the clinical trial, as far as they are caused by regulation.

·
Objective No 2:
Regulatory requirements which are adapted to practical considerations,
constraints and needs, without compromising the safety, well-being and rights
of participants in clinical trials and without compromising data robustness.
This means the operational objectives of reducing administrative burdens
and operational costs as regards two key regulatory requirements: the annual
safety report and the obligatory insurance/indemnification.

·
Objective No 3:
Addressing the global dimension of clinical trials when ensuring compliance
with GCP. This means the operational objective of ensuring compliance
with GCP of clinical trials conducted in non-EU countries.

4.           Policy Options

4.1.        Objective No 1 — A modern regulatory
framework for submission, assessment and regulatory follow-up of applications for
clinical trials

4.1.1.     Policy option No 1/1 — No action at Union level and
reliance on voluntary cooperation of Member States (baseline option)

4.1.2.     Policy option No 1/2 — Single
submission with separate assessment

10.         This policy option would consist
of central submission, via an IT gateway located at EU-level, and subsequent
separate assessment in each Member State concerned.

4.1.3.     Policy
option No 1/3 — Single submission with joint assessment by Member
States of issues not related to ethical aspects

11.         This policy option would consist
of central submission and subsequent joint assessment by the Member States
where the clinical trial takes place. Under this policy option the involvement
of the Commission or the Agency (apart from the single submission point, see
above) would be limited to technical support of the joint assessment, and to acting
as 'facilitator' in the joint assessment.

4.1.4.     Policy option No 1/4 — Single submission with
central assessment by the Agency of issues not related to ethical aspects

12.         This policy option would consist
of central submission and subsequent central assessment by a scientific
committee located and administered within the European Medicines Agency ('Agency').

13.         In addition, each Member
State concerned would issue a national decision covering the ethical aspects of
the clinical trial.

4.1.5.     Policy option No 1/5 –
Choice of legal form: adopting the text of the Clinical Trials Directive in the
form of a Regulation

4.1.6.     Policy option No 1/6 –
Combination of policy option No 1/3 (joint assessment) and No 1/5 (legal form
of a Regulation)

4.2.        Objective No 2 — Regulatory requirements adapted to practical
considerations and needs

4.2.1.     Policy option No 2/1 — No action at Union level (baseline
option)

4.2.2.     Policy option No 2/2 —
Enlarging the scope of non-interventional trials

14.         The Clinical Trials
Directive applies only to ‘interventional trials’, but not to ‘non-interventional’
trials. Non-interventional trials are trials with authorised medicines, where
subjects are not assigned in advance and where no additional intervention takes
place. This policy option would broaden the scope of non-interventional trials by
removing the last requirement (additional intervention). Consequently, the
scope of the Clinical Trials Directive would be narrowed.

4.2.3.     Policy option No 2/3 —
Excluding ‘non-commercial sponsors’

15.         The requirements laid down
by the Clinical Trials Directive are particularly onerous for sponsors who do
not always have the means and resources to comply with them. This mainly applies
to ‘non-commercial sponsors’. ‘Non-commercial sponsors’ are usually
universities or academic institutes, foundations or charities. This policy
option would follow the example of the U.S. and Japan by excluding ‘non-commercial
sponsors’ from the scope of the regulation of clinical trials.

4.2.4.     Policy option No 2/4 — Removing regulatory requirements on the basis of the knowledge of the IMP

16.         This policy option would
remove certain regulatory requirements (for example the compulsory
insurance/indemnity and the obligatory annual safety report) for clinical
trials with authorised medicinal products used for the authorised indication or
with IMPs used in a well-known use.

4.2.5.     Policy option No 2/5 —
Insurance/Optional ‘national indemnification mechanism’

17.         This policy option is
relevant only for the issue of the obligatory insurance/indemnity. It would put
Member States under an obligation to provide for an indemnification mechanism for
clinical trials performed on their territory, taking account of the national
legal system for liability. It would be optional for sponsors to join this
national indemnification mechanism.

4.2.6.     Policy option No 2/6 –
Combination of policy option No 2/4 and No 2/5

18.         This policy option is only
relevant as far as the obligatory insurance/indemnification is concerned:
Low-risk clinical trials would be excluded from the obligatory
insurance/indemnification (policy option No 2/4). Other clinical trials would
be covered by the obligatory indemnification mechanism (policy option No 2/5).

4.3.        Objective No 3 — Addressing the global dimension of clinical
trials when ensuring compliance with GCP

4.3.1.     Policy option No 3/1: Leaving the situation as it is
(baseline option)

19.         The ‘self-regulation’
option would mean continuing to rely on voluntary commitment on the part of
sponsors to ensure that clinical trials in non-EU countries are performed in
accordance with GCP, regulatory supervision and inspections by non-EU countries
in their jurisdictions, and some inspections by the inspectors of Member States
in the framework of applications for marketing authorisation.

4.3.2.     Policy
option No 3/2: Facilitating GCP inspections by increasing transparency

20.         This option would put
sponsors under an obligation to register publicly all clinical trials whose
results are used subsequently in an application for authorisation of a clinical
trial or for marketing authorisation for a medicinal product. This would allow
enforcement authorities to intervene and police these clinical trials. It would
also build up pressure for sponsors to comply with GCP.

4.3.3.     Policy option No 3/3: Inspections of non-EU countries'
regulatory systems for clinical trial

21.         This option introduces the
possibility for the Commission or the Agency to conduct 'system inspections' in
non-EU countries, in order to assess whether their regulatory and enforcement
system for clinical trials is equivalent to that in the EU.

4.3.4.     Policy option No 3/4: GCP
inspections by the Agency in non-EU countries

22.         Under this option the
Agency or Commission would be empowered to performing inspections in clinical
trial sites in non-EU countries without drawing on inspection capacity provided
voluntarily by Member States.

4.3.5.     Policy option No 3/5:
Combination of policy option No 3/2 and No 3/3

5.           Assessment of Impacts

5.1.        Objective No 1 — A modern regulatory
framework for submission, assessment and regulatory follow-up of applications for
clinical trials

5.1.1.     Policy option No 1/1: No action at Union level and
reliance on voluntary cooperation of Member States (baseline option)

23.         In terms of social/health
impacts, the current ‘patchwork’ of separate assessment procedures for
clinical trials by each Member State concerned does not necessarily ensure the
highest possible standard of assessment in the EU. Moreover, the same clinical
trial may be subject to different changes and adjustments in the authorisation
procedure. These divergences can have an impact on data generated in the trial.
If the conduct and design of the trial diverge too much, sponsors decide to
withdraw the clinical trial from one or more Member States. This means that
patients in those Member States are deprived of the potential benefits of
clinical research, which leads to inequalities in public health.

24.         In terms of economic
impact the Clinical Trials Directive creates administrative costs of approximately
306 m EUR per year and operational non-administrative costs of approximately
2 200 m EUR per year.

5.1.2.     Policy option No 1/2 — Single submission with separate
assessment

25.         As regards the impact on
terms of health and patient safety there would be no change compared with
the present situation.

26.         In terms of economic
impact this policy option would reduce administrative costs to 45.5m EUR. In
terms of operational costs, however, the situation would be identical to policy
option No 1/1, as this policy option is limited to an IT-tool to submit
information. In terms of implementation costs, the one-off costs for IT and to running
costs vary depending on the technical solution and range between 1.62m EUR and
6.3m EUR one-off costs, plus running costs between 0.34m EUR (plus 0.25 FTE)
and 1.26m EUR (plus 19 FTEs). The choice as to which technical solution is
to be pursued is intrinsically linked to the decision as to where the single
submission point is located at the Agency or at the Commission. This is a
political decision to be taken at a later stage, to which the impact assessment
serves as aid.

5.1.3.     Policy option No 1/3 — Single
submission with joint assessment by Member States of issues not related to
ethical aspects

27.         In terms of social/health
impact, the protection and the safety and rights of participants would
improve as compared with the baseline option, as expertise of different Member
States would be brought together. A uniform response to the request for
conducting a clinical trial would allow quicker start of a clinical trial on
the basis of an identical protocol, thus removingthe inequalities identified in
the baseline option.

28.         In terms economic impact,
this policy option would have largely the same impact as No 1/2. It would
reduce administrative costs to 34.3 m EUR, a saving of 271.7 m EUR
per year compared with the baseline option. In terms of operational costs, this
policy option would lower the costs for performing clinical trials in the EU considerably
(savings would be in the range of 440 m EUR).

29.         Depending on the extent of
the support structure resource needs are between 1.5 and 7 FTEs. The choice as
to the scale of the support structure is linked to the decision who provides
the support structure: the Agency or at the Commission. This is a political
decision to be taken at a later stage, to which the impact assessment serves as
aid.

5.1.4.     Policy option No 1/4: Single submission with central
assessment by the Agency of issues not related to ethics

30.         In terms of social/health
impact, this policy option has the benefit of involving all Member States,
thus assembling the best expertise of regulators available. However, this
option might lead to additional delays in the start of a clinical trial because
the dual approval system (national and EU level) is likely to lead to
contradictions, hence creating additional delays in solving these. Moreover, the
involvement of every Member State, including Member States not necessarily concerned,
would add to the complexity of the discussions and of finding a compromise. In
addition, this policy option would lead to an ‘institutional continuum’ between
the authorisation procedure for clinical trials throughout development of a
medicinal product and the marketing authorisation of the resultant product.
This carries the risk of removing a 'fresh pair of eyes' that assesses the data
at the end of the development process during the marketing authorisation
application.

31.         In terms of economic
impact/costs, this policy option would lead to savings of 264.2 m EUR
in administrative costs. In terms of operational costs, the impact would be
similar to policy option No 1/3, i.e. savings of approximately 440 m EUR.
In terms of implementation costs, these would relate largely to an additional
role of the Agency. It can be estimated that the additional staff needs would
be in the range of 4 000 FTEs.

5.1.5.     Policy
option No 1/5 — Choice of legal form — Adopting the text of the Clinical Trials
Directive in the form of a Regulation

32.         This policy option would
ensure that the Member States would base their assessment of an application for
authorisation of a clinical trial on an identical text, rather than on various,
inevitably diverging, national transposition measures.

5.1.6.     Policy option No 1/6 –
Combination of policy option No 1/3 (joint assessment) and No 1/5 (legal form
of a Regulation)

33.         In this policy option the
joint assessment (pol. opt. No 1/3) would be strengthened by a legal text in
the form of a Regulation (No 1/5). This would facilitate cooperation between
Member States in the assessment of a clinical trial application.

5.2.        Objective
No 2 — Regulatory requirements adapted to practical considerations and needs

5.2.1.     Policy option No 2/1: No action at Union level (baseline option)

34.         The obligatory
insurance/indemnity ensures that, in case of damages caused by a clinical
trial, the subject receives compensation — irrespective of the financial means
of the sponsor or investigator. The annual safety report can be a useful tool for
NCAs or ECs to supervise and follow up the safety profile of an IMP, particularly
if the compound is still largely unknown and not yet authorised.

35.         The yearly costs for the obligatory
insurance/indemnity and the safety report are approximately 222.8 m EUR,
plus administrative costs of 7.2 m EUR. On the other hand, approximately
0.025 % of all subjects successfully claim compensation for damages suffered
in a clinical trial. Each damages claim is worth, on average, between 3 000
and 6 000 EUR.

5.2.2.     Policy option No 2/2 — Enlarging the scope of
non-interventional studies

36.         In terms of social/health
impact the immediate impact would be that these studies would be regulated
at national level by Member States. Depending on the measures taken by each Member
State, this would mean tighter, looser or no regulation of this type of study.
In terms of economic impact/costs this policy option would generate
savings of 16.98m EUR operational costs, plus 219 000 EUR administrative
costs.

5.2.3.     Policy option No 2/3 — Excluding ‘non-commercial sponsors’

37.         In terms of social/health
impact, subjects enrolled in a clinical trial run by an ‘non-commercial
sponsor’ would not be protected at EU level. Nor would the EU rules ensuring the
robustness and reliability of data apply. This would be a major drawback in
terms of a creating a level playing field for conducting clinical trials in the
EU without compromising on protection of rights and safety of patients in the
EU and data robustness in the EU. This policy option would also have a negative
impact on public health in general. Clinical trials run by ‘non-commercial
sponsors’ can have a crucial impact on public health as the results may be
published and, thus, impact to the choice of treatment options and treatment in
general.

38.         In terms of economic
impact/costs this policy option would generate savings of 73.9m EUR
operational costs, plus 926 000 EUR administrative costs.

5.2.4.     Policy
option No 2/4: Removing regulatory requirements on the basis of the knowledge
of the IMP

39.         Clinical trials with
authorised medicinal products pose a risk to public health which is typically only
minimally higher to that posed by standard care, if at all. Thus, removing the
obligatory insurance/indemnity and the obligation to submit an annual safety
reporting would have no discernible impact on subject protection. In
particular, regarding insurance, if an (unlikely) damage occurs, there would be
a number of additional types of insurance such as product liability insurance
of the marketing authorisation holder for the authorised medicine, and
professional negligence insurance by the treating physician.

40.         In terms of economic
impact/costs this policy option would generate savings of 34m EUR
(operational costs) and 438 000 EUR administrative costs.

5.2.5.     Policy option No 2/5 —Insurance/optional
‘national indemnification mechanism’

41.         A national indemnification mechanism
would give the same assurance of compensation for any subject suffering damages
as the obligatory insurance/indemnity currently required by the Clinical Trials
Directive.

42.         Administrative and
operational costs for sponsors would be limited and produce important savings
compared to the baseline option. In terms of implementation costs, as the
number of damage claims granted is very limited, costs for Member States would
be limited to approximately 0.817m EUR per year.

5.2.6.     Policy option No 2/6 –
Combination of policy option No 2/4 and No 2/5

43.         The impact in terms of
public health and patient safety would be the sum of the policy options No 2/4
and No 2/5: Low-risk trials would be covered by other liability schemes
(product liability etc.). Other than low-risk trials would be covered by the
national indemnification scheme. In terms of economic impact/costs, the
savings in this policy option would be 0.03m EUR higher than in policy
option No 2/5.

5.3.        Objective No 3: Addressing
the global dimension of clinical trials when ensuring compliance with GCP

5.3.1.     Policy option No 3/1:
Leaving the situation as it is (baseline option)

44.         This policy option would
not address the questions raised in the problem definition.

5.3.2.     Policy option No 3/2: Facilitating GCP inspections by increasing transparency

45.         This policy option would
contribute to securing compliance with GCP with the aid of a stronger degree of
transparency. The economic impact/costs for sponsors will mainly be felt
in the administrative costs (approximately 6.72m EUR per year) for
submitting information on clinical trials in non-EU countries to a public
register.

5.3.3.     Policy option No 3/3: Inspections of non-EU countries'
regulatory systems for clinical trial

46.         This policy option would
contribute to ensuring that clinical trial data referred to in EU marketing
applications is reliable and robust. It would strengthen the general rule that
clinical data from third countries has to stem from clinical trials which are
based on principles equivalent to those in the EU.

47.         In terms of economic
impact/costs, the implementation costs are most relevant: they are at approximately
5 FTEs per year, plus costs of approximately 76 000 EUR.

5.3.4.     Policy option No 3/4: GCP
inspections by the Agency in non-EU countries

48.         This policy option would
contribute to securing compliance with GCP in clinical trials performed in a non-EU
country. However, it would remain impossible to inspect all sites regularly and
systematically. Moreover, inspections are usually conducted in the context of
the marketing authorisation procedure, i.e. many years after the clinical trial
has ended.

49.         Resource needs at EU level
would be approximately 1 300 FTEs.

5.3.5.     Policy option No 3/5:
Combination of policy option No 3/2 and No 3/3

50.         This combination of policy
options would further strengthen the impact of the policy options taken
individually: the transparency (policy option no 3/2) allows better targeting
inspections of non-EU countries' regulatory systems.

6.           Comparison of Options

6.1.        Objective No 1 — A modern regulatory
framework for submission, assessment and regulatory follow-up of applications for
clinical trials

51.         The baseline situation is
insufficient to address the problem. While policy options No 1/2 (separate
assessment), No 1/3 (joint MS assessment) and No 1/4 (assessment by the Agency)
have one common element (the single submission point), they are mutually
exclusive.

52.         The common element which is
part of policy options No 1/2, No 1/3 and No 1/4 greatly reduces administrative
costs and thus contributes to addressing the problem.

53.         Policy option No 1/2,
however does insufficiently address issues of separate assessments of identical
issues in relation to the same clinical trial. In this respect, policy options
No 1/3 and 1/4, which address not only the submission process, but also the
assessment process of a clinical trial application, are to be favoured. When
comparing policy options No 1/3 and No 1/4, it results that policy option No 1/4
sets up a very heavy system which is prone for delays. It involves every Member
State, which is not necessary in view of the roll-out of clinical trials. Only approximately
6 % of all clinical trials are rolled out in eight Member States or more. Considering
this it seems disproportionate to involve every Member State in the assessment
of clinical trial application. Added to this the dual approval (EU and
national) stemming from policy option No 1/4 adds new complexities which would
be avoided in No 1/3.

54.         Policy option No 1/3
provides a ‘slimmer’ procedure than policy option No 1/4. For the initial
authorisation it involves only the Member States where the clinical trial is to
be performed (a mechanism would have to be set up to allow roll-out to
additional Member States subsequently). Under policy option No 1/3 approval is
also likely to be cheaper and faster than in No 1/4. This is in particular of
interest for academic research and SMEs.

55.         Policy option No 1/5
(Regulation vs. Directive) is not an alternative but an add-on. It would ensure
an approach in assessment of a clinical trial and follow-up action, based on
identical criteria.

56.         Policy option No 1/6 is a
combination of policy options No 1/3 and 1/5. It contributes further to
achieving the objective No 1 by providing an identical legal framework for
authorisation of clinical trials, thus facilitating cooperation between Member
States as foreseen under policy option No 1/3. this helps to achieve the
operational objectives of reducing in particular administrative burdens and
delays.

6.2.        Objective No 2 —
Regulatory requirements adapted to practical considerations and needs

57.         The baseline does not
address the problem identified. Options No 2/2 (enlargement of the scope of
non-interventional trials) and No 2/3 (exclusion of "non-commercial
sponsors") have the effect of ‘shifting back’ regulation to Member States.
In addition, regarding policy option No 2/3 it is difficult to see why rules
designed to protect the safety and rights of participants and the reliability
and robustness of data should apply to some types of sponsors but not to
others.

58.         Policy option No 2/4 (removing
requirements on the basis of the knowledge on the IMP) brings about less
savings for sponsors than policy option No 2/3. However, in terms of public
health and patient safety it is superior to policy option No 2/3 as it leaves aside
any differentiation between ‘non-commercial’ and industry sponsors and focuses
on an objective criterion: the authorisation status of the IMP.

59.         Policy option No 2/5 (national
indemnification mechanism) can be a useful, cost-effective tool to address the
specific issue of obligatory insurance/indemnity.

60.         Policy option No 2/6 is a
combination of policy option No 2/4 and 2/5. The combination reduces
administrative burdens beyond policy option No 2/5 without compromising on
patient safety.

6.3.        Objective No 3: Addressing
the global dimension of clinical trials when ensuring compliance with GCP

61.         The baseline option is not
satisfactory. Policy options No 3/3 (Inspections of non-EU countries'
regulatory systems for clinical trial) and No 3/4 (GCP inspections by the
Agency in non-EU countries) have relatively similar effects in terms of
achieving the objective, even though the approach is different. Their impact
diverges considerably as regards the impact on resources at EU level. Regarding
policy option No 3/4, the budgetary constraints do not allow, at present, an
increase in inspection activity in line with policy option No 3/4. The
assessment of the impact of policy option No 3/3 shows that much can be
achieved with far fewer resources than specified in policy option No 3/4.

62.         Policy option No 3/2 (obligation
of registration of all clinical trials) can make a useful contribution to
effective control over clinical trials performed in non-EU countries. The
burden for the sponsor, which is limited to administrative costs, is acceptable
in view of the benefits created by this policy option.

63.         Policy option No 3/5 is a
combination of policy option No 3/2 and No 3/4: This combination strengthens
further the tools to verify and ensure compliance, as it allows more targeted
system inspections.

7.           Preferred choice of
options

64.         Regarding objective No 1,
the preferred choice of policy option is No 1/6, which allows for a fast
approval without setting up a new, central bureaucracy. In addition, in this
policy option the legal form of a Regulation facilitates cooperation between
Member States. Regarding objective No 2, the preferred policy option is No 2/6,
which reduces costs (administrative burdens and operational costs) considerably
without compromising on patient safety. Regarding objective No 3, the preferred
policy option is no 3/5, which combines a resource-effective inspection of
regulatory systems with a higher degree of transparency, in order to be able to
target inspections.

8.           Monitoring and Evaluation

65.         A key indicator for achievements
of the objectives is the number of clinical trials applied for in the EU, the
number of multi-national clinical trials performed in the EU, the costs for
clinical trials generated by legislation, and delays in launch of a clinical
trial. This will be assessed by the Commission through regular reports from the
EU-database on clinical trials, a public consultation and organisation and
participation of fora where the legislation is evaluated by
stakeholders.

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