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

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

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.

Study Overview

• Status: Completed
• Conditions: Health, Subjective; Health Knowledge, Attitudes, Practice; Safety Issues
• Intervention / Treatment: Other: Inspection and safety evaluation by 3 longstanding experience physicians of early clinical researches

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All the 30 sites of Ile de France region fully authorized to perform phase I/II trials

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of observations which have potentially serious medical consequences after experts adjudication	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number on disagreements occuring initially among the 3 adjudicators before adjudication	Up to 2 years

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Pitie-Salpetriere
• Investigators: Principal Investigator: Christian Funck-Brentano, MD, PhD, INSERM, CIC-1421 and UMR ICAN 1166, Sorbonne Université, Faculty of Medicine, AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology and Clinical Investigation Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: safety dysfunctions
• Other Study ID Numbers: CIC1421-19-08