French Jardé's law and European regulation on drug trials: Harmonization and implementation of new rules.

Jardé's law, concerning research studies in humans, was enacted in March 2012 but did not come into force until November 2016. This delay is largely explained by the adoption of a European regulation on clinical trials on medicinal products that will probably not be applicable until October 2018. In addition to covering the respective areas of the French and European legislation, the round table provided an opportunity to discuss the principal measures that will apply to future research, particularly those concerning the operational procedures of the ethics committees and the national committee for research in humans, as well as measures relating to the management of serious adverse effects, more specifically in phase I studies in subjects not presenting with any disorder. This round table also enabled the formulation of recommendations to better anticipate the practical difficulties that the regulatory changes might engender. Finally, we highlight the numerous challenges in terms of training that these important regulatory changes impose and the absolute necessity to best adapt the restrictions to those that are planned in numerous other European countries so that France remains competitive in terms of clinical research and so that French patients may continue to benefit rapidly from the most innovative treatments.

How is functionning the Ethical Review Board « Comité d'Ethique Pour La Recherche En Obstétrique Et Gynécologie ¼ (CEROG) ?

INTRODUCTION: The French College of Gynecology and Obstetrics (CNGOF) has created an Ethical Review Board called the CEROG that aim to ensure the research projects are in conformity with the regulation and the laws, as well as to allow their publication in international scientific journals. The aim of this work was to analyze the work of this committee through the application received and to review the ethical procedures required by type of research project. METHODS: We conducted a national retrospective study of all applications from 2018 to 2021 received by the CEROG Ethical Review Board. Each application must contain a verification of conformity with the MR004 regulation, a submission form and an information form to the patients involved. At reception, the documents are anonymized and then addressed to the members of one of the two independent sections (Obstetric and Prenatal diagnosis or Gynecology and Assisted Reproductive Therapy). RESULTS: Two hundred and sixty applications were received, including 52% in the Gynecology section and 48% in the Obstetrics' section. Only 10% (14/136) and 8% (10/124) were disapproved, respectively. In total, 35% of the applications to the Gynecology section leaded to publications in scientific journals but only 23% did so in the Obstetrics section. Most publications (60.8%) were in low impact factors journals (rank D and E). CONCLUSION: The Ethical Review Board CEROG is essential to ensure the conformity of the research projects with French regulations and allow fast publication in international journals.

[French regulation of medical research]. / Réglementation de la recherche médicale en France.

In France, clinical research involving human beings is regulated by the Jardé's law since November 2016. The law distinguishes interventional and non-interventional studies. Both need to be authorized by a Persons Protection Committee. Studies performed on medical data collected during standard clinical care are not considered as studies involving human beings. Medical data are personal data. French Data Protection Authority National has an important role, guarantying the respect of regulation on personal data. We summarize in this article the different types of studies and the role of regulatory authorities.

Regulatory aspects of prospective and retrospective clinical research in France in 2018.

In France, the so-called "Jardé law" (named for its proposer) on human research, implemented since 2016, defines the regulatory and legal framework for "prospective" studies, formerly known as "biomedical research" or "common care". Three categories are distinguished: type 1 is at-risk drug or non-drug interventional research, type 2 is low-risk, low-burden interventional research, and type 3 is non-interventional research. The decrees of April 12, 2018 precisely define a list of research categories for types 2 and 3, thereby clarifying the regulatory procedures. The Sponsor registers the trial on the database of the National Drug Safety Agency (ANSM), or the European EudraCT database for drug studies, to obtain an identification number. Regulatory procedures are undertaken with the IRB and ANSM and then the Data Protection Commission (CNIL). Retrospective research on previously collected data (other than genetic) does not come under the Jardé law, and is governed by the 1978 data protection law, updated by the application decree of December 2016 and the law No. 2018-493 of June 20, 2018 on protection of personal data. This article presents a clarification of the key methodologic and regulatory steps.

[Evolution of the regulatory framework in clinical research]. / Évolution du cadre réglementaire de la recherche clinique.

The regulatory framework of clinical research is necessary to ensure the protection of participants and to define the actors and their responsibilities. Although main principles have been set up in 1947 with the Nuremberg Code, this regulatory framework is relatively recent in Europe: development of national regulations in the years 1980-1990, first European Directive regarding clinical trials in 2001. In France, as 2006 was marked by the implementation of this first "Clinical trials Directive", the end of the year 2016 and the following months were marked by the enforcement of the Jardé law (previously modified in order to reinforce the regulatory requirements following the death of an healthy volunteer in a clinical trial). As clinical researches involve processing of personal data, the entry into force, on 25 May 2018, of the General Data Protection Regulation (GDPR) had also consequences on their implementation. Finally, regarding clinical trials on drugs, the "Clinical trials Regulation" repealing the Directive, voted in 2014, should come into force in the coming months.