Health Knowledge, Attitudes, PracticeHARMONYNCT03943017
The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident
An observational study of Health Knowledge, Attitudes, Practice and Safety Issues, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Knowledge, Attitudes, Practice, Safety Issues, Health, Subjective
- What is being tested?
- Inspection and safety evaluation by 3 longstanding experience physicians of early clinical researches
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 20 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the 30 sites of Ile de France region fully authorized to perform phase I/II trials
Who may be able to join
- Being one of the 30 sites of Île-de-France region fully authorized to perform phase I/II trials
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Paris, 75013
About this study
Official title: The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident: Medical vs. Regulatory Relevance
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.
Read the 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.
- Being tested
- Inspection and safety evaluation by 3 longstanding experience physicians of early clinical researches
- Keywords
- safety dysfunctions
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspection and safety evaluation by 3 longstanding experience physicians of early clinical researchesOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of observations which have potentially serious medical consequences after experts adjudication
Measured: Up to 2 years
Secondary outcomes (1)
Number on disagreements occuring initially among the 3 adjudicators before adjudication
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start1 Jan 2017
- Primary completion30 Jul 2019
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
- Investigators
- Christian Funck-Brentano, MD, PhD, Principal investigator, INSERM, CIC-1421 and UMR ICAN 1166, Sorbonne Université, Faculty of Medicine, AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology and Clinical Investigation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943017
- Sponsor's protocol ID
- CIC1421-19-08
- Acronym
- HARMONY
- Status last verified
- Apr 2023
- First submitted
- 6 May 2019
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident: Medical vs. Regulatory Relevance
- ClinicalTrials.gov ID
- NCT03943017
- Acronym / sponsor ID
- HARMONY / CIC1421-19-08
- Keywords
- safety dysfunctions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the 30 sites of Ile de France region fully authorized to perform phase I/II trials
Key inclusion criteria (1 listed)
- Being one of the 30 sites of Île-de-France region fully authorized to perform phase I/II trials
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspection and safety evaluation by 3 longstanding experience physicians of early clinical researchesAdjudicate 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. | Other | – |
Primary outcome
Number of observations which have potentially serious medical consequences after experts adjudication
Time frame: Up to 2 years
1 secondary outcome
Number on disagreements occuring initially among the 3 adjudicators before adjudication
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Funck-Brentano, MD, PhD principal investigator
INSERM, CIC-1421 and UMR ICAN 1166, Sorbonne Université, Faculty of Medicine, AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology and Clinical Investigation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Knowledge, Attitudes, Practice and Safety Issues, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of observations which have potentially serious medical consequences after experts adjudication (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.