Anyone, providing certain conditions are met, may take part in a clinical trial. This undertaking should not be driven by personal interest, but rather the desire to contribute to progress in terms of health.
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Without clinical trials, there would be no new therapeutic methods, no new medicinal products: treatments cannot be circulated if their efficacy and safety have not been demonstrated. Hence, thousands of citizens embark on clinical trials with the aim of testing new medicinal products each year.
Who can take part in a clinical trial?
Whether unwell or in good health, any person may be invited to take part in health research. This invitation may arise during a doctor's appointment, but also via posters or media adverts. Individuals may also volunteer independently, by contacting clinical and health research organizations, such as the Clinical Investigation Centers (CICs) at Inserm.
Volunteering does not necessarily mean that an individual will be automatically included in a trial. Each study has a number of inclusion criteria, based on age, sex, disease type and stage, medical history, and concomitant diseases. These criteria ensure that the groups are homogeneous, and that reliable, relevant and robust results are therefore obtained.
The investigating physician is the volunteer's main contact
Clinical trials must be conducted under the direction and supervision of a competent physician who is an expert in the relevant research field. This person is known as the investigator. S/he must provide the volunteers with clear information on:
- the study objective
- its methodology
- the expected benefits
- the obligations and foreseeable risks
- their right to refuse to take part in a study
S/he must also obtain their written informed consent, in compliance with the law.
Any person having given their consent to take part in a study is free to withdraw their consent at any time, and thus end their participation in the study, without this having any impact on their future care.
Before effectively taking part in the clinical research project, the participant undergoes a preliminary medical examination, adapted to the study, the results of which are communicated to the participant either directly or via their chosen physician.
What are the rights of individuals taking part in clinical research?
The law clearly stipulates that the interests of persons taking part in clinical research always prevail over scientific and social interests. It also stipulates that the research must be designed so as to minimize pain, inconvenience and fear.
The main rights of clinical trial volunteers are as follows:
- They can take time to talk to their family members and attending physician if they so wish, before deciding to take part in the study
- They may withdraw from the trial at any time, without having to state a reason, by simply telling the study doctor
- They may receive information on their health
- They may receive notification of any serious events affecting one or more participants during the trial
- They may receive information on the overall results of the trial
- They may verify and rectify their personal data
- They may object to the transfer of their personal data
- They may obtain compensation in the event of harm
Remuneration of participants for their troubles (treatment administration, medical visits, follow-up examinations, hospitalization, etc.) is provided for by law: the conditions and sums are verified by an ethical research committees (CPP).
This remuneration is not automatic and is prohibited for vulnerable persons (such as children), for ethical reasons. Participation in clinical trials is under no circumstances intended to become a "means of remuneration".
Furthermore, the sponsor of health and clinical research is required to take out third-party liability insurance. This insurance allows participants to receive compensation if they sustain harm due to the research.
Volunteer for a clinical trial
You would like to take part in a clinical trial: here is a list of sites at which studies are recruiting volunteers, together with the contact details in order to submit your application.
- Drug trial directory (French National Agency for Medicines and Health Products Safety - Ansm)
- Registry of clinical trials in cancer (French National Cancer Institute - INCa)
- Clinical trials on rare diseases (Orphanet)
- Clinical trials worldwide
- Seintinelles network (cancer research)
- ComPaRe (project supported by Assistance Publique - Hôpitaux de Paris, on chronic diseases)
You can also contact the Inserm Clinical Investigation Centers.