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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03943017

Acronym

HARMONY

Enrollment

Registered

2019-05-09

Start date

2017-01-01

Completion date

2023-04-20

Last updated

2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

safety dysfunctions

Brief summary

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.

Interventions

OTHERInspection 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.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Number of observations which have potentially serious medical consequences after experts adjudication	Up to 2 years

Secondary

Measure	Time frame
Number on disagreements occuring initially among the 3 adjudicators before adjudication	Up to 2 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026