[Reporting of harms in clinical trials: Vigilant support to the investigator. A guideline of REVISE' Group]. / Sécurité des essais cliniques : accompagnement de l'investigateur par le vigilant pour la publication des données de sécurité. Une ligne directrice du groupe REVISE.
Therapie
; 71(5): 475-481, 2016 Oct.
Article
in Fr
| MEDLINE
| ID: mdl-27423828
ABSTRACT
Since August 9, 2004, the 2001 European Directive for clinical trials is applied to the French law. Since the 2006 implementing decree amending public health law on biomedical researches, safety data are managed by sponsor vigilant. Competent authorities collect sponsor's data, implement the vigilance system (Article L. 1123-12 of French Health Code) and supervise drastically safety data in clinical research from clinical trial authorization to final report. However, although available to competent authorities, final reports are not addressed to scientific community, who has only access to scientific publications for clinical trials safety data. Final report is under sponsor's responsibility (Article R. 1123-60 of French Health Code), but scientific publication is written by the study coordinating investigator. Therefore, at the end of the clinical trial, two actors will interpret safety data from the same database but with different scientific objectives. The lack of reporting of harms in scientific communications impacts the information. The REVISE group (safety officers of French institutional sponsors) suggests help to investigators in the safety data writing for their trial scientific publication. The group published a guideline, based on the international recommendations for publications of safety data in randomized clinical trials and expanded its scope to all clinical trials.
Key words
Full text:
1
Database:
MEDLINE
Main subject:
Clinical Trials as Topic
/
Guidelines as Topic
/
Drug-Related Side Effects and Adverse Reactions
/
Patient Safety
Type of study:
Clinical_trials
/
Guideline
Limits:
Humans
Country/Region as subject:
Europa
Language:
Fr
Journal:
Therapie
Year:
2016
Type:
Article
Affiliation country:
France