Clinical research refers to all studies conducted in humans in the field of health. Highly supervised, such research is only performed under certain conditions and after obtaining a regulatory opinion. Its aim is to identify new therapeutic avenues and improve knowledge of diseases. It covers all research projects carried out in humans.
A clinical trial – also referred to as a clinical study – is used to test new treatments and evaluate their effectiveness before offering them to all patients. For example, we can test new molecules, combinations of different molecules, new methods of administration and new treatment techniques. In all cases, the trials are validated according to a rigorous protocol.
Institutional clinical research is of paramount importance, as it investigates aspects not covered by industrial clinical research. It can evaluate treatments, vaccines, diagnostic tools, therapeutic or prevention strategies in order to measure, for example, their efficacy, safety and feasibility. Such research also makes it possible to deepen knowledge and obtain proofs of concept. It is funded by the state or by associations and is sometimes supported by the pharmaceutical industry. Its sponsors are doctors, hospitals or public institutions.
Adults, adolescents, children: anyone, whether or not they have an illness, can volunteer to participate in clinical research. Being a volunteer does not necessarily mean that you will be accepted to participate in the research, as each study has its own inclusion and exclusion criteria to guarantee the safety of the participants and the reliability of the results.
For paediatric research projects, while only the written consent of the parents is required, the child’s personal agreement is systematically sought. Given that anyone under the age of 18 is considered to be a ‘child’, the information is provided in an age-appropriate way.
Although the reasons for participating in a clinical trial are specific to each individual, clinical research is certainly of major importance to the field of health. All current treatments have been discovered thanks to research. To participate in research is to commit to the health and quality of life of everyone.
With clinical trials, we can:
- validate scientific progress resulting from basic research,
- discover and develop treatments that were previously non-existent,
- improve existing treatments,
- provide new knowledge to understand, prevent, treat and improve diagnoses.
For patients, it is also the possibility of participating in an innovative trial under maximum safety conditions, for example enhanced medical follow-up and access to a treatment before it is brought to market.
Many stakeholders are involved in the smooth running of a clinical trial.
- The sponsor: a natural or legal person (company or institution) that takes the initiative for the trial. The sponsor ensures the funding and assumes the responsibilities. It is in charge of the entire organisation of the trial, its implementation and follow-up.
- The investigator: a healthcare professional who directs and supervises the conduct of the trial. For clinical trials involving medicinal products, this must be a medical doctor. For those involving medical devices, these are healthcare professionals (doctors, nurses, physiotherapists, etc.). The investigator is accompanied by a team that is trained in clinical research.
- The competent authorities: the authorities that supervise a clinical trial. These are:
- The French National Agency for Medicines and Health Products Safety (ANSM), which issues Sponsors with authorisations for all clinical trials. The ANSM may suspend or terminate a trial at any time.
- The French Data Protection Authority (CNIL), which ensures the confidentiality of the data collected during the research.
- The Ethics Committee is an independent body that provides an ethical opinion on all research involving human subjects.
- The participant: someone who volunteers to take part in a trial, whether or not they have an illness. Those who are considered by law to be ‘vulnerable’, such as minors and pregnant women, are given special attention in order to protect them.
Clinical studies are conducted in four phases:
- Phase I evaluates the tolerability of a new medicinal product to determine the recommended dose. It concerns a small number of participants.
- Phase II tests the efficacy of the treatment and involves a larger number of patients in order to have a more representative population and statistically more reliable data.
- Phase III evaluates the therapeutic benefit of the medicinal product on a much larger number of patients (a few hundred).
- Phase IV is the close monitoring phase referred to as ‘pharmacovigilance’, which takes place once the medicinal product is on the market.
There is no such thing as zero risk. However, clinical research is highly supervised and the participants closely monitored.
Before being tested on humans, the medicinal products used are tested several times on cells in the laboratory, and then on different animal species.
Projects are only carried out if they meet maximum safety conditions governed by:
- The Ethics Committee, which assesses the conditions for the information and consent of the participants, the validity and relevance of the research project and its methodological quality. The Ethics Committee also verifies that the rights of the participants will be respected and, in particular, ensures respect for the confidentiality and management of personal data.
- The ANSM, which is the competent authority for evaluating and authorising a clinical research project (involving medicinal products). For clinical research projects that do not involve medicinal products, prior authorisation from the ANSM is not required. However, the latter must be informed before the project can begin. It is responsible for monitoring the safety of clinical research projects throughout their implementation.
To participate in a clinical trial, the participant must have given their informed consent. Defined in the French Public Health Code, consent is said to be ‘informed’ when the participant has received all the necessary information from the Investigator on the following points:
- the objectives, duration and methodology of the clinical research,
- the expected benefits,
- the foreseeable constraints and risks, including in the event of early termination of the research,
- any medical alternatives,
- the medical care at the end of the trial, if necessary, in the event of exclusion or termination of participation before the end of the trial,
- the opinion of the Ethics Committee and the authorisation of the competent authority,
- if necessary, the prohibition to participate simultaneously in another study and/or the exclusion period following the study as well as the inclusion of the participant in the national registry of research participants,
- the rights of the participants.
This information is provided on a written document and given to the person whose consent is being sought. Consent is evidenced by the signature of a consent form indicating that the person has received all the information they asked for regarding the clinical trial.
Special provisions exist for minors, protected adults (under some form of guardianship) and adults unable to express their consent.
You have the right to refuse to take part in a clinical trial.
The protection of participants in clinical research is guaranteed by law. The law clearly stipulates that the interests of people taking part in clinical research always prevail over those of science and society. It also stipulates that the research must be designed so that pain, inconvenience and fear are reduced to a minimum.
During a clinical trial, all participants have the right to:
- take the time to discuss it with their family and their doctor before making a decision,
- withdraw from the trial at any time, without incurring any liability or prejudice,
- be kept informed of their state of health during and at the end of the research,
- be kept informed of any serious events affecting one or more participants during the trial,
- be kept informed, at the end of the research, of its overall results,
- verify and rectify their personal data,
- object to the transfer of their personal data,
- obtain compensation in the event of harm.
Clinical research participants are not paid.
However, compensation for the constraints suffered (taking the treatment, medical visits, follow-up examinations, time spent, hospitalisations, etc.) is provided for by law. Its terms are verified by the Ethics Committees and its amount is capped.
This compensation is not systematic. For ethical reasons, it is forbidden for vulnerable people, such as children.
If the research in which you are participating provides for compensation, the payment terms and amount will be specified in the information document given to you.
