Clinical research refers to the 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. This research is essential in order to better understand and treat diseases, and identify potential risk factors. In France, this research is governed by the Jardé law.
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 health 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, relevant for implementing prevention strategies
- compare existing diagnostic or therapeutic approaches, which may then be useful in the preparation of patient treatment guidelines, etc.
Three research categories
In France, research involving human subjects (RIPH) is governed by legislation distinguishing three categories: interventional research, interventional research with minor obligations and risk, and non-interventional research.
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) and the level of risk and obligations involved for those agreeing to take part.
Interventional research (Category 1)
This involves intervention that is not without risk for the participants, and not warranted by their usual care. 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. It was previously known as « biomedical research ». In common parlance, this is research that is referred to as a « clinical trial ».
Interventional research with minor obligations and risk (Category 2)
This 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 ».
Non-interventional research (Category 3)
Despite its name, non-interventional research involves procedures or interventions defined by law. 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 tolerability 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 acquired
- 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 also requires mandatory authorization from the French National Agency for the Safety of Medicines and Health Products (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 (medical 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.
Inserm and clinical research
Inserm is currently responsible for 250 research projects. The Directorate General entrusts this activity to the Clinical Research Unit, under the egis of the Public Health Theme-Based Institute. This unit assists the investigators with the various procedures necessary for the implementation of their project, up to its closure with publication of the results.
Clinical Investigation Centers (CICs)
Inserm’s Clinical Investigation Centers (CICs) offer researchers and clinicians the necessary resources to pass on the results of basic research to patients. This stage of research, in which knowledge and technology are mobilized for the benefit of health, is known as translational clinical research.
Discover the Inserm CICs (in French)