Trials / Completed
CompletedNCT03943017
The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident
The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident: Medical vs. Regulatory Relevance
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (actual)
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2019-07-30
- Completion
- 2023-04-20
- First posted
- 2019-05-09
- Last updated
- 2023-04-21
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03943017. Inclusion in this directory is not an endorsement.