|
| |
European Medicines Agency Workshop On First-in-man Clinical Trials Draft Guideline |
|
|
The European Medicines Agency held a workshop on 12 June 2007 as part of
the public consultation on the draft guideline on requirements for
first-in-man clinical trials for potential high-risk medicinal products.
Attended by some 150 people, the workshop complements the extensive
written comments already received from 57 organisations representing
pharmaceutical industry, contract research organisations, clinical
research organisations, ethical committees, academia, healthcare
professionals, animal welfare organisations and patients' organisations.
The draft guideline gives guidance on managing the transition from
non-clinical studies, e.g. studies in animals or in vitro studies, to
first tests in humans. It describes the principles of a science-based
approach ensuring the safety of subjects and respecting ethical
principles while allowing for flexibility.
While the criteria described in the draft guideline to be taken into
account in the non-clinical area for identifying potential risks and for
implementing risk management strategies for the phase I clinical trials
were generally supported, one main area of debate emerged from the
public consultation.
This was the concept of classification of high-risk versus non-high-risk
medicinal products. Proposals were made to replace it with a risk
management and risk mitigation approach based on the concept of risk as
a continuum for all medicinal products. These suggestions will be taken
into account in the finalisation of the guideline planned in the coming
weeks.
1. The Agenda of the workshop and presentations given can be found here.
2. The draft guideline can be found here. It was released for a two-month public consultation period from 22 March to 23 May 2007. A press release was issued and is available here.
3. A Community guideline is a document considered to provide advice
to sponsors, applicants or marketing authorisation holders, national
competent authorities and/or other interested parties on the best way to
fulfil an obligation laid down in the Community pharmaceutical
legislation. Scientific guidelines are Community guidelines that relate
to specific scientific issues and reflect a harmonised EU approach,
based on the most up-to-date scientific knowledge. Guidelines are not
binding. Sponsors may deviate from the recommendations of the guideline
provided they can substantiate their approach.
4. Clinical trials are undertaken to allow data on the safety and
efficacy of new medicinal products to be collected. The first-in-man
trial is the initial step of the clinical development of a medicine in
humans and is part of the Phase-I or early-development clinical trials.
Phase-I trials are designed to look at the initial safety and
tolerability, as well as the pharmacology and pharmacokinetics of the
medicinal product concerned. Studies in this phase of development
usually have non-therapeutic objectives and may be conducted in healthy
volunteer subjects.
5. Clinical trials are regulated by European Union Directive
2001/20/EC, of 4 April 2001. The Directive harmonises across EU Member
States the administrative provisions governing clinical trials, as well
as the standards of good clinical practice (GCP) and good manufacturing
practice (GMP) to which they are conducted. It is the responsibility of
national competent authorities to assess applications to conduct
clinical trials with medicinal products.
6. This press release, together with other information on the work
of the EMEA, can be found on the EMEA website:
European Medicines Agency
Publication Date: 2007-06-20 03:00
|
|
|
