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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Inspection and safety evaluation by 3 longstanding experience physicians of early clinical researches


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being one of the 30 sites of Île-de-France region fully authorized to perform phase I/II trials Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Inspection and safety evaluation by 3 longstanding experience physicians of early clinical researches|Adjudicate each ARC's observations according to the 3 physicians perceived medical importance regarding safety; first, adjudications are performed separately. Then disagreements are settled during a final adjudication meeting between them.|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety dysfunctions