An observational study in Health Knowledge, Attitudes, Practice, Safety Issues and Health, Subjective, sponsored by Groupe Hospitalier Pitie-Salpetriere. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2023-04-21.
Sponsored by Groupe Hospitalier Pitie-Salpetriere · Observational
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.
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.
Groupe Hospitalier Pitie-Salpetriere is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All the 30 sites of Ile de France region fully authorized to perform phase I/II trials
Exclusion Criteria:
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.
Number of observations which have potentially serious medical consequences after experts adjudication
Time frame: Up to 2 years
Number on disagreements occuring initially among the 3 adjudicators before adjudication
Time frame: Up to 2 years
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Groupe Hospitalier Pitie-Salpetriere