What is clinical research?
Scientific and medical innovations have to demonstrate a possible efficacy as well as an acceptable tolerance so that patients can benefit from it. Therefore, it is essential to assess them in humans under strict conditions of safety, quality and ethics, and in full respect of current regulations. This is the subject of clinical research.
Clinical research is carried out in humans, on volunteers who are sick or not, with respect for the person and the integrity of each individual.
Within Imagine Institute, clinical research concerns several fields:
- Therapeutic methods: drugs, medical devices, etc.
- Diagnostic tests through biological tests or imaging, etc.
The term “clinical research” integrates all types of research below:
- Research involving human subjects (RIPH) and who come within the framework of the French Jardé law. it is made up of three categories:
- Category 1, interventional research, which involves an intervention on the person unjustified by his/her usual treatment. This mainly concerns clinical trials and medical devices,
- Category 2, interventional research with minimal risks and constraints. This concerns research that does not relate to drugs and only has minimal risks and constraints like blood samples for example (if they do not exceed a certain volume in relation to the subject’s weight), but also data collection by means of sensors or imaging methods, as well as interviews and questionnaires for which the results, in accordance with the protocol, can lead to the participant’s treatment being modified,
- Category 3, prospective, non-interventional research concerns research with no risk or constraint for the participant. Procedures are carried out and products are used in the usual manner. There are no additional or unusual procedures for diagnosis, treatment or monitoring. Example: questionnaires.
- Research on data or biological collections is non-interventional research on existing data or samples. This research does not come within the framework of the French Jardé law. This is the case, for example, with theses and dissertations carried out from existing medical records or from reusing biological samples.
Imagine: from research to clinic
To accelerate the availability of its discoveries, Imagine Institute gives additional resources to researchers and deploys clinical research programs. Indeed, clinical research is a key stage in the development of new diagnostic and therapeutic approaches improving patient care.