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.
Our objective is to facilitate the promotion of clinical research and the implementation of clinical trials in the field of innovation at Imagine for the researchers and clinicians of our founding members, AP-HP, Inserm and the University of Paris. We will support them throughout the project, from its conception up to its publication
For this, the clinical research department at Imagine Institute has implemented a system to assist with promotion and investigation serving the reference centers for rare diseases and the clinical departments at Necker-Enfants malades hospital AP-HP that make up the clinical scope of Imagine, in close collaboration with the clinical research core facilities at Necker-Enfants malades hospital AP-HP (CRU, CIC-BT).
The sponsorship team is made up of project managers and a clinical research officer. The investigation team is made up of clinical research coordinators, clinical study technicians and mobile clinical research nurses. At an earlier stage, the clinical research coordinators and clinical study technicians intervene to consider the feasibility of the trial with the trial investigator, to set up and start studies, help select patients, increase the number of enrollments and manage clinical trials on a daily basis.
In 2018, 15 reference centers for rare diseases out of the 25 established at Imagine Institute were able to benefit from this assistance.
The studies conducted are managed directly by the investigation team or with support from the Mother-Child Clinical Investigation Center (CIC) at Necker-Enfants malades hospital AP-HP.
Mobile clinical research nurses play a key role in the care of patients taking part in clinical trials. They take samples that are essential to the research projects , providing a connection between the medical teams and trial sponsors.
In 2018, 580 clinical studies enrolling more than 7000 patients were underway within the clinical scope of IHU Imagine, involving the reference centers for rare diseases and the clinical departments at Necker-Enfants malades hospital affiliated at Imagine.
Half of the studies related to research on a drug, medical device, cell or gene therapy, and nearly 50% were phase III clinical trials, for which the objective was to test the efficacy of a treatment.
The sponsors of these studies are either industrial (41.5%), or institutional (58.5%). Themes investigated by Imagine teams and laboratories represent more than a third of the 580 studies conducted in 2018. Clinical research coordinators and clinical study technicians at Imagine took part in 94 studies, of which 39% mobilized mobile clinical research nurses.
An objective: double clinical trials
In the coming years, Imagine is focused on the goal of doubling the number of clinical trials within the reference centers for rare diseases to eventually double the therapeutic solutions.
Today, 61 therapeutic solutions are being tested in the labs at Imagine, in the pre-clinical or clinical stages, in the hope that they will be successfully concluded in the next 2 to 5 years in aid of more than 100 rare diseases targeted by these solutions.