Clinical research – within the meaning of France’s Jardé Law – corresponds to scientific studies performed on human subjects with a view to furthering biological or medical knowledge. These are prospective studies that require the follow-up of patients or healthy volunteers.
Often, when we talk about clinical research, what first springs to mind are clinical trials in which new medicinal products, medical devices or biologics are evaluated. But this healthcare research field is much broader than that, with clinical research also used to, for example:
- identify molecular or cellular mechanisms implicated in diseases (which may then lead to the identification of new therapeutic targets),
- identify genetic or environmental risk factors (which may then lead to the deployment of prevention strategies),
- compare existing diagnostic or therapeutic approaches (which may then be useful in the preparation of patient treatment guidelines).
Three research categories
Essential for elucidating diseases as well as improving their prevention and treatment, research involving human subjects (RIPH) in France is governed by legislation distinguishing three categories. These categories differ mainly in terms of:
- the type of intervention envisaged in the research protocol, whether or not it modifies the participants’ usual treatment
- the level of risk and obligations involved for those agreeing to take part
Interventional research (Category 1) involves intervention that is not without risk for the participants, and not warranted by their usual care.
Previously known as biomedical research, it mainly concerns research on medicinal products, but also other types of interventions such as surgical procedures, the evaluation of medical devices and cell and gene therapy.
Interventional research with minor obligations and risk
Interventional research with minor obligations and risk (Category 2) may include minimally invasive procedures or interventions, the list of which is defined by law (blood samples within certain volume limits, questionnaires possibly leading to changes in care based on the results, radiological examinations without injection of contrast agent, etc.). Health products or medicinal products may be used under their normal conditions of use and if they are not the specific subject of the study.
Part of this research corresponds to what used to be designated as research evaluating usual care.
Despite its name, non-interventional research (Category 3) involves procedures or interventions defined by law. Since they are without risk, this form of research does not modify the participants’ existing care – with the various procedures performed or products used falling within the scope of standard practice.
It includes observational research: studies observing treatment compliance, the tolerance of a medicinal product once it is on the market, the practices of one treatment center compared with those of another, etc.
Rules to be followed
In all cases, this research must:
- be supported by a sponsor who is responsible for its management, who ensures respect of the good practices guaranteeing the integrity of the study and who verifies that the necessary funding is available
- have obtained a favorable opinion from an Ethics Committee
- receive French data protection authority (CNIL) authorization concerning the processing of the participants’ personal data (or respect a reference methodology)
Category 1 research requires mandatory authorization from the French National Agency for Medicines and Health Products Safety (ANSM). For Category 2 and 3 research, the ANSM is simply notified of the Ethics Committee opinion, without its authorization being required.
Research is led and supervised by an investigator (doctor, healthcare professional or person qualified in the field concerned by the research) who must:
- inform the individuals invited to take part in the research on the study objectives, methodology, expected benefits, obligations and foreseeable risks, their right to refuse to participate in the study and their right to withdraw their consent at any time,
- collect their agreement to participate in the study and ensure that they have properly understood the information given. Depending on the study category, this agreement may take the form of consent (written, express) or non-objection.
Research on biological specimens and data
Retrospective research, concerning existing biological samples or existing data, does not fall within the scope of the Jardé Law on research involving human subjects. Nevertheless, a regulatory framework requires that those having supplied their samples or data be protected.
For further reading, visit Notre Recherche Clinique (in French)