The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident

Completed

• Conditions: Safety Issues; Health Knowledge, Attitudes, Practice; Health, Subjective

• Registration Number: NCT03943017
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief Summary

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 Authorized Research Centers (ARC) conducting phase I/II clinical trials of experimental drugs.

Detailed Description

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.

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

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Primary Completion: 2019-07-30
• Status Verified: 2023-04
• Study Completion: 2023-04-20
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Being one of the 30 sites of Île-de-France region fully authorized to perform phase I/II trials

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of observations which have potentially serious medical consequences after experts adjudication	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Number on disagreements occuring initially among the 3 adjudicators before adjudication	Up to 2 years

Trial Locations

Locations (1)

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM; 🇫🇷 Paris, France