title: French Jardé's law and European regulation on drug trials: Harmonization and implementation of new rules.
abstract: 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.
authors.affiliation: Univ. Lille, Inserm, CHU Lille, CIC 1403, centre d'investigation clinique, F-59000 Lille, France. Electronic address: dominique.deplanque@univ-lille2.fr.
authors.forename: Dominique
authors.initials: D
authors.lastname: Deplanque
authors.affiliation: Astrazeneca, 92400 Courbevoie, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Sénéchal-Cohen
authors.affiliation: UPEC, 75014 Paris, France.
authors.forename: François
authors.initials: F
authors.lastname: Lemaire
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D005060:Europe; D006801:Humans
keywords: Adverse effects; Clinical research; Ethics committee; European regulation; Jardé’s law; Phase I; Regulation; Training