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Explanatory memorandum on clinical trials in the
QoL-Programme with reference only to
2001 Workprogramme

Introduction
Clinical trials have taken an important role in the delivery of health. In recent years it
became evident that the validation and evaluation of potential therapies in a precise
clinical setting is the major bottleneck in delivering new medicines or new medical
interventions to patients. Moreover, institutional clinical research in Europe needs to
be strengthened in order to cover medical fields that are not necessarily of prime
interest to the pharmaceutical industry but of high relevance to the public health sector.
In the mid-term of FP5, clinical trials are a major tool to meet one of the main QoLProgramme objectives: the improvement of the quality of life and health status of the
European citizen. This paper will address opportunities across the different research
activities funded under the QoL-programme and explain the conditions for funding.

Definition and phases of clinical trials
A clinical trial is an internationally recognised research protocol designed to evaluate
safety and/or efficacy of drugs, vaccines or new therapies or new ways of using known
treatments and to produce scientifically valid results. Whenever possible, it is
organised as randomised controlled trial.
Four phases of trials are routinely distinguished. The first testing of a new treatment in
human beings is called Phase I trial. The main focus is the evaluation of safety and, in
the case of pharmaceuticals, also the evaluation of pharmacokinetics. A Phase II
clinical trial further evaluates the safety of a new treatment, explores dose and optimal
schedules and begins to evaluate its efficacy. In a Phase III clinical trial the safety and
efficacy of a new treatment is compared to the established standard of care. Results
from Phase III clinical trials form the basis for regulatory authorities to approve new
treatments. Phase IV trials are performed after a drug or medical device has been
approved by regulatory authorities and serve as post market surveillance, which can
reveal any side effect. They can have one or more of several objectives: e.g. - safety
and efficacy comparison with other products already on the market, - long-term
effectiveness and impact on patient’s quality of life - cost-effectiveness of a new
therapy relative to others.

Conditions for clinical trials in the QoL-programme
Although the rationale and the clinical research performed in the various action lines
across the QoL-programme might be quite different, the following conditions have to
apply in order to qualify for Community support:

That the trial outcome, in compliance with accepted ethical standards, is of
potential benefit and accessible to the patient.
 That the project makes a substantial contribution to public health priorities.
 That the major focus of the trial is not near term commercial profit. Clinical trials
that ought to be exclusively funded by industry will not be considered for EC
funding.
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
Opportunities for submission in the QoL-programme
In the QoL-programme, proposers can submit proposals on clinical trials in the
following action lines: Key Action 1 (Food, Nutrition and health), 2 (Control of
Infectious Diseases), 3 (The “Cell Factory”), 6 (The ageing population and
disabilities) and in Generic RTD-Activities 7 (Chronic and Degenerative Diseases,
Cancer, Diabetes, Cardiovascular Diseases and Rare Diseases), 9 (Neurosciences)
(see table I).

For phase I and II clinical trials
Case 1: Through Demonstration projects
Key Action 2, Key Action 3 and Neurosciences (area 9.3 of Generic RTD Activities)
supports the early clinical testing of treatments (phase I, phase II) through
demonstration projects. Demonstration projects are aimed at bridging the validation
gap by transferring laboratory results and/or results in animal experiments into realistic
evaluation in the clinic. They thus represent a relevant “proof of concept”. This
demonstration of “value” will foster the adoption of drugs, vaccines and therapies. The
partnership should include a proper balance of both technology producers and
technology users. Industrial participation is encouraged in order to promote future
developments of medicines and to ensure their large and rapid diffusion.
Demonstration projects are financed by the Community at a rate of up to 35% of the
eligible project costs (for industrial partners). In the case of legal entities that do not
keep analytical accountancy, the additional cost generated, as a result of these projects
will be financed at the rate of 100% (notably for Universities, Hospitals, etc.). (See
also guide for proposers, part 2, page 6 and 7).
Key Action 2 focuses on the early clinical testing of vaccine and drug candidates. The
link between research and exploitation in Key Action 3 is demonstrated through
clinical trials in the areas 3.1.2 (Therapeutic substances) and 3.1.3 (Therapeutic
strategies). In area 9.3, clinical trials address new therapeutic approaches for
neurological as well as psychiatric disorders.
Case 2: Through Demonstration projects, Concerted Actions or Thematic
Networks
For Key Action 6 (area 6.1: Age related illnesses and health problems, area 6.2
Determinants of healthy ageing and of well-being of old age and area 6.4 Coping with
functional limitations in old age) phase I and phase II clinical trials may be supported
as demonstration projects, concerted actions or thematic networks. Phase III and phase
IV clinical trials will however be supported only as concerted actions or thematic
networks.
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Case 3: Through RTD, DEMO, Combined projects
In Key Action 1, clinical trials are only possible in area 1.3 Food and Nutrition, which
is about the role of food in promoting and sustaining health. Work on drug
development is not foreseen in Key Action 1. The clinical trials only involve phases I
and II and are accepted as components of RTD-, Demonstration and Combined
Projects1.

For phase III and IV clinical trials
Case 4: Through Concerted Actions and Thematic Networks
In large-scale clinical trials (phase III, phase IV) only the networking is supported by
Key Actions 2, 3 and 6 through Concerted Actions and Thematic Networks.
Case 5: Through RTD projects
Area 7 of Generic Activities, (Chronic and Degenerative Diseases, Cancer, Diabetes,
Cardiovascular Diseases and Rare Diseases) will use RTD projects to support
multicenter phases III and IV clinical trials to provide a foundation for evidence-based
medicine where there is no direct interest of industry to finance these studies. Such
trials should be on long-term effectiveness and side effects associated with long termuse, on comparisons of safety / efficacy and costs between new and known treatments
and on targeted therapy for high risk populations.

Ethical aspects in clinical trials.
In all cases described above, careful consideration has to be given to ethical aspects in
proposals for clinical trials, notably:
- justification for such research in terms of the potential benefits of the research in
relation to the possible risk;
- informed consent;
- authorisation or approval of local ethical committees, national bodies;
- specification and reference of all relevant national and international regulations.
Proposals that are successfully evaluated for their scientific merit and relevance may
indeed be subject to further review by an independent panel of experts on ethical
matters.

Safety aspects in clinical trials
In all cases described above, careful consideration has to be given to potential safety
implications in proposals for clinical trials including safety monitoring, authorisation
or approval of local or national safety committees and compliance with EC or national
safety regulations.
1
In projects where the clinical trial will form only a minor part of the overall project, these projects may
be funded as RTD projects in order to avoid unnecessary complications for the contractors.