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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03943017
Other study ID # CIC1421-19-08
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date April 20, 2023

Study information

Verified date April 2023
Source Groupe Hospitalier Pitie-Salpetriere
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 20, 2023
Est. primary completion date July 30, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM Paris

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of observations which have potentially serious medical consequences after experts adjudication Up to 2 years
Secondary Number on disagreements occuring initially among the 3 adjudicators before adjudication Up to 2 years
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