Citation

Henry C, Odoul F, Megnigbeto C, Lebourgeois B, Doz F, Funck-Brentano C. Therapie 2020; ePub(ePub): ePub.

Affiliation

INSERM, CIC-1901 and UMR ICAN 1166, Sorbonne university, faculty of medicine, AP-HP, Pitié-Salpêtrière hospital, department of pharmacology and clinical investigation center Paris-Est, institute of cardiometabolism and nutrition (ICAN), 75013 Paris, France. Electronic address: christian.funck-brentano@aphp.fr.

Copyright

(Copyright © 2020, John Libbey Eurotext)

DOI

10.1016/j.therap.2019.12.013

PMID

31992452

Abstract

AIMS: Following the serious adverse events that occurred in January 2016 during the BIA 10-2474 First-in-Human study, the French Ministry of Health asked the Regional Health Agencies to inspect operations at all research sites conducting phase I/II clinical trials of experimental drugs. The aim of this study was to assess the medical relevance of the inspections made in Île-de-France (Paris region) in 2017.

METHODS: All 30 sites of Île-de-France region fully authorized to perform phase I/II trials were inspected by a public health physician and a public health pharmacist. Their reported list of observations was submitted to three physicians with longstanding experience of early pharmacology studies performed in academic or private research facilities. These physicians were asked to adjudicate each observation according to their perceived medical importance regarding safety. Adjudications were first performed separately and disagreements were later settled during a final adjudication meeting.

RESULTS: At least one disagreement occurred initially among the 3 adjudicators for 84 of the 120 observations (70%) reported by the inspectors. Following reconciliation, the 3 physicians agreed that 20% of the observations were likely to have potentially serious medical consequences. These observations mainly concerned the management of emergencies and of serious adverse events and the continuity of care.

CONCLUSIONS: Maintenance of on-site inspections periodically carried out by regulatory authorities granting authorisations to perform phase I/II trials are justified. However, the medical relevance of these inspections can be improved with more emphasis on factors affecting the safety of research participants than on administrative or purely regulatory issues.

Copyright © 2020 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Language: en

Keywords

Accreditation; Biomedical research; Clinical trials as topic; Government regulation; Quality assurance