Medicine can’t cure everything and it needs new efficient and properly assessed treatments to get better. Research aims at managing children better to cure as many of them as possible with as less sequela as possible. Treatment must be as safe as possible but there will always be some risk and uncertainty because of innovative treatments or the therapeutic strategy. In any case it is the child’s interest which comes first. Participation to a research improves current treatments. In the future, sick children will still benefit from outcomes of current researches like today’s children benefit from previous biomedical researches.
Physicians must comply with the 1964 Helsinki declaration. Moreover, the HURIET SERESCLAT law of August 19, 1964 regulates biomedical research. Safety of persons who lend themselves to biomedical research in France is in tune with the European directive of 04/04/2001. Ethical Research Committees review each biomedical project so that no trial can be launched without their authorization. They review each project according to the following criteria: research relevance and scientific guarantee, positive assessment of expected benefit and risks, quality of information means. Pediatric oncologic centres focus on national and international researches.
In addition to the Ethical Research Committees agreement, the French National Agency for Medicines and Health Products Safety reviews also all aspects of the research and can veto a trial in the absence of safety measures. It is an additional stage of authorization.
The IHOPE is authorized to perform therapeutic trials on children. It relies on an adult structure of the Centre Léon Bérard and perform daily phase I trials. It is an early phase trial centre and an important member of the ITCC (Innovative therapy for cancer in Children). The Centre Léon Bérard may also perform trials on children within the ITCC.
Clinical research: centre certified by the National Cancer Institute (INCa) as an oncology early clinical trial centre (CLIP2)
Further to the 2014-2019 cancer plan, the French Cancer Institute certified 16 new early clinical trial centres in 2016 (CLIP2). A specific attention was born on territory coverage and the creation of early clinical trial centres having also a pediatric early phase activity. The IHOPE is one of these centres.
Early phase (I-II) protocols give access to innovative treatments.