What is a clinical trial?
A clinical trial is a biomedical research organized and practiced on humans for the development of biological or medical knowledge.
The objective of drug-based clinical trials is, as appropriate, to establish or verify certain pharmacokinetic data (modalities of drug absorption, distribution, metabolism and excretion), pharmacodynamic drug action) and therapeutic (efficacy and tolerability) of a new drug or a new way of using a known treatment.
The test can be done in the sick volunteer or the healthy volunteer.
To begin, the trial must have obtained a favorable opinion from the Committee for the Protection of Persons (C.P.P.) and an authorization from the National Agency for the Safety of Medicines and Health Products (ANSM).
The CPP gives its opinion on the conditions of validity of the research, in particular with regard to:
- the protection of individuals, including the protection of participants;
- the adequacy, comprehensiveness and intelligibility of the written information to be provided as well as the procedure for obtaining informed consent, and the rationale for research on individuals who are unable to give informed consent;
- the possible need for a reflection period;
- the possible need to include in the protocol a prohibition to participate simultaneously in another search or a period of exclusion;
- the relevance of the research, the adequacy of the assessment of the expected benefits and risks and the validity of the conclusions; the match between the objectives pursued and the means implemented;
- the qualification of the investigator (s). amounts and terms of compensation of participants; how to recruit participants.
Throughout the duration of the trial, the ANSM is kept informed of serious and unexpected adverse effects that may be related to the investigational drug and of any new developments related to the research likely to call into question the safety of the persons who are suitable for research. ; it can make any decision concerning these tests (suspension, prohibition).
The objective, the conditions for carrying out and carrying out the test, the methods of inclusion, information, treatment and supervision of the persons participating in the trial by the investigating physicians and the procedures for collecting information on the efficacy and tolerance of drugs are defined in a pre-established protocol.
What is a promoter?
The sponsor is the natural or legal person who initiates the clinical trial.
It can be a pharmaceutical laboratory (French or foreign), a service provider, an association, a care establishment, a natural person (for example a doctor).
What is an investigator?
The investigator directs and monitors the completion of the clinical trial.
For clinical drug trials it is a doctor with appropriate experience. For clinical trials in the field of dentistry, a dental surgeon, together with a doctor with appropriate experience, may exercise direction and supervision of the research.
What is a coordinating investigator?
When the sponsor entrusts the execution of a clinical trial to several investigators (multicenter trials), he designates among them a coordinating investigator.
What information should be provided to people participating in a clinical trial? A clinical trial can not be conducted without prior information from the person being tested and without giving informed consent.
Before accepting or refusing to participate in a clinical trial, the person is informed by the physician conducting the trial or a doctor who represents it:
- the purpose, methodology and duration of the research; expected benefits, constraints and foreseeable risks, including if research is terminated before completion; possible medical alternatives;
- medical care arrangements provided at the end of the research, if such support is necessary, in case of premature termination of the research, and in case of exclusion of the research;
- the favorable opinion of the CPP and the authorization of the ANSM
- his right to have, during or after the research, information concerning his health, which he holds;
- where applicable, the prohibition to participate simultaneously in another search or the period of exclusion provided for by the protocol and its entry in the national file;
- the right to refuse to participate in a search or withdraw consent at any time without incurring any liability or prejudice thereby.
The information provided is resummed up in a written document given to the person. Consent is given in writing.
For each clinical trial, there are specific criteria for inclusion of participants in the trial. These criteria are usually based on the person's age, illness and medical history.
The inclusion criteria are not intended to reject a person in a personal capacity, but they are intended to select the participants appropriately so as not to incur excessive risk if they are led to perform the test.