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

Safety Issues Clinical Trial

Official title: The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident: Medical vs. Regulatory Relevance

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice
• Health, Subjective
• Safety Issues

• NCT number: NCT03943017
• Study type: Observational
• Source: Groupe Hospitalier Pitie-Salpetriere
• Status: Completed
• Start date: January 1, 2017
• Completion date: April 20, 2023