Clinical research covers all scientific studies conducted on humans, with a view to developing biological or medical knowledge. These are prospective studies which require follow-up of a patient or healthy volunteer, as opposed to studies conducted on previously collected samples or previously compiled databases.
The different types of human research are strictly controlled by legislative texts (Jardé Law). Before they can be implemented, a favorable opinion must be obtained from an ethical research committee (Comité de protection des personnes - CPP) and, in certain cases, authorization from the competent authorities (Ansm, CNIL, etc.).
This research is essential in order to have a better understanding and/or more effective treatment for diseases, and to identify potential risk factors. Its ultimate goal is to improve our health, by preventing risks and improving treatment.
Three research categories
There are three types of research involving humans, which differ in terms of:
- their interventional or non-interventional nature
- the level or risk and obligations for the person agreeing to take part
Interventional research (Category 1) involves intervention on the subject, not warranted by their usual care. Previously known as biomedical research, clinical trials or therapeutic trials, this research involves intervention which is not devoid of risk to participants.
This 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 limits, questionnaire possibly leading to changes in care based on the results, radiological examination 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.
Non-interventional research (Category 3) is known as observational studies. This does not include any intervention in patient management, and does not present any risks, or obligations. All procedures performed or products used fall within the scope of standard practice. For example, this may involve a study on adherence to a given treatment or a management strategy. This research requires a simple statement of non-objection by the participant, in contrast to the two previous categories which require consent to be obtained from the person taking part in the study.
Rules to be followed
In all cases, this research must:
- be supported by a sponsor which is responsible for management and ensures that the necessary funding is available
- have obtained a favorable opinion from an ethical research committee (CPP)
- comply with a CNIL reference methodology (or receive formal authorization in the event of noncompliance with the reference methodology) concerning personal data protection for participants
Category 1 research requires mandatory authorization from the French National Agency for Medicines and Health Products Safety (Ansm), whereas category 2 and 3 research is simply submitted to this Agency for information.
Inserm and Clinical Research
A very large number of clinical studies are currently in progress in France. The sponsors – i.e. the entities initiating and taking responsibility for the research - are pharmaceutical companies or public research organizations.
At Inserm, the Directorate General assigns this activity to the Clinical Research Unit, under the auspices of the Public Health Theme-Based Institute. This center takes charge of all procedures related to creation of the project, from drawing up the expert report and obtaining the regulatory authorizations, to monitoring and close-out of the study.
The implementation of Inserm clinical research activities is, moreover, supported by the scientific and methodological expertise of its research infrastructures, together with the relevant head office divisions (financial and legal affairs, value creation and intellectual property unit, etc.). Special relationships with the investigators/scientists and collaboration with external experts and partners enable studies to be run efficiently.
The scope of studies sponsored by Inserm is in keeping with the requirements of the Inserm strategic plan and scientists. It is part of the clinical landscape in France, Europe and the whole world. Inserm thus sponsors more than a dozen international projects, many of which fall within the scope of the European Horizon 2020 programs.
The Clinical Research Unit, moreover, supports scientists and investigators in their regulatory procedures concerning studies on collections or previously collected data (research "outside the scope of the Jardé Law").