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Completed

NCT Number: NCT03943017

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being one of the 30 sites of Île-de-France region fully authorized to perform phase I/II trials

Exclusion criteria

  • None

Treatment and study plan

Inspection and safety evaluation by 3 longstanding experience physicians of early clinical researches

Other

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.

Primary outcomes

  1. Number of observations which have potentially serious medical consequences after experts adjudication

    Time frame: Up to 2 years

Secondary outcomes

  1. Number on disagreements occuring initially among the 3 adjudicators before adjudication

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Official study title

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

Acronym: HARMONY

Important dates

Study start
2017
Primary completion
2019
Study completion
2023
First posted
May 9, 2019
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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