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What is a clinical trial ?

Researcher at work.
A clinical trial consists of studying the effects of a molecule in humans according to a precise protocol, either in sick or healthy volunteer subjects. The aim of clinical trials is to assess the safety and efficacy of a substance. The development of new drugs follows three main phases. In rare diseases, the number of patients included in the different phases is reduced due to the rarity of the diseases.A drug which is already commercialised for a given indication may obtain an MA (Market Authorisation) extension for another disease, only on the basis of phase II and III clinical trials. In rare diseases, scientific and medical academic teams often take the initiative of evaluating the potential interest of existing drugs.


Update of the computer graphic (october 2004) : Protocole/Administrative procedures

The European Directive relating to clinical trials, adopted in 2001, was to be transposed in the member states by 1 May 2003 for application on 1 May 2004.
In France the necessary texts were integrated into the Public Health Act promulgated on 9 August 2004 and published in the Journal Officiel (a government publication) on 11 August 2004.
The central themes are as follows: replacement of a declarative system by one of authorisation, adaptation of the conditions of vulnerable persons, setting up of a database a part of which will be integrated into a European database etc.
The French Agency for the Safety of Health Products (AFSSAPS) will play a more important role throughout the duration of the trial. From now on, it will grant a CTA (clinical trial authorisation) within a maximum period of 60 days, based on an EMD (experimental medical dossier).
The dossier for a CTA request consists of three parts :
- an administrative dossier
- a clinical trial dossier (including the trial protocol)
- a technical dossier relating to the products used in the trial which includes the EMD and the dossier relating to other products (for example, the placebo)
AFSSAPS will issue a clinical trial authorisation after evaluation of the data available concerning the products to be used and the protocol envisaged.
During the trial, AFSSAPS will also give amendment authorisations and receive the result at the end of the trial.
The Consultative Committees for the Protection of Persons taking part in Biomedical Research (CCPPBR) will become Committees for the Protection of Persons (CPP). The Committee’s recommendations are no longer consultative but deliberative. It is integrated for a fixed period and with territorial competence. Its favourable recommendation is obligatory for a research project to begin.


Update 2006/09/13
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