Tightly controlled research
Rules for interventionist studies
Around half of all clinical studies are interventionist, meaning that they require an intervention with the patient to assess a new treatment, new therapeutic combinations, new exams, protocol-based psychological monitoring or just to improve knowledge of the disease and its treatments. These studies are always developed by a group of experts and reviewed in institutional committees.
Information forms must mention the goals of the trial, the number of patients that it will include, the sequence of the study, the expected benefits as well as the constraints of the study, possible alternative treatments, the possibility of withdrawal of consent, the rights of patients and their beneficiaries, and the identity of the referring physician to be contacted for questions about this study and the possibility of being informed of the results at a later date.
Stopping a study
There are very strict rules for stopping these interventionist studies in order not to expose patients to excessive toxicity or ineffective treatment.
The patient protection law
This law protects people taking part in biomedical research. The Huriet-Sérusclat law of 1988 was the first to provide a legal framework for clinical trials in France. Since then, new laws and directives have been added to this framework. They impose specific rules, so that the patient gives free and informed consent, and his/her consent is obtained in writing. This consent form must be signed by the patient and by the investigator. The most recent law in this regard is the Jardé law of 5 March 2012 relating to research on humans. It came into force following publication of its draft on 16 November 2016, and strengthens the safety of clinical trials.
Institutional review boards (IRB)
There are about 40 of these in France. The role of these boards is to issue their opinion on the protocols and examine the information and consent notice, which must be clear, precise and complete. To examine the protocols, an IRB is selected at random at national level. Each board has some 10 members in fields as diverse as medicine, pharmacology, psychology, nursing care, social care, ethics and law. They also have two association representatives. This diversity ensures that a variety of opinions are presented.
Pediatrics: information and consent
When a patient is a minor and has the opportunity to take part in a clinical trial, information must be explained as fully as possible to the parents, and the delivery of a written information document is mandatory. The information must also be provided to the child in an age-appropriate manner, and a written document may be given to the child depending on his/her age.
A consent form is presented – and explained – to the parents or legal guardians, who must sign it before the commencement of a trial involving the child. The signature of the child or adolescent is not mandatory, but it is also possible depending on the child’s age and wishes.
Use of health data
Patients’ medical records contain considerable amounts of information, collected for the day-to-day management of their care, including analyses, imaging, treatments and relapses. These data collected in the records of thousands of patients are very important and are a valuable source of research, even when collected outside of prospective studies. Prospective collection of the data, with parental consent, and direct implementation of anonymized databases is helping the cause of research both now and in the future.
Institut Curie supports the sharing of health data with respect for privacy. There are technical solutions that guarantee this. Studying the health data means that better care is provided, but such studies must be respectful and confidential. Physicians, researchers and computer scientists work in conjunction with the legal department and are very careful when it comes to ethics, safety and management of data-access rights.