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

NCT03943017 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-04-21

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Groupe Hospitalier Pitie-Salpetriere

    lead OTHER

Principal Investigators

  • Christian Funck-Brentano, MD, PhD · INSERM, CIC-1421 and UMR ICAN 1166, Sorbonne Université, Faculty of Medicine, AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology and Clinical Investigation Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-07-30
Completion
2023-04-20

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03943017 on ClinicalTrials.gov