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

Groupe Hospitalier Pitie-Salpetriere

Status

Completed

Conditions

Safety Issues

Health Knowledge, Attitudes, Practice

Health, Subjective

Treatments

Other: Inspection and safety evaluation by 3 longstanding experience physicians of early clinical researches

Study type

Observational

Funder types

Other

Identifiers

NCT03943017

CIC1421-19-08

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria