title: [Reporting of harms in clinical trials: Vigilant support to the investigator. A guideline of REVISE' Group].
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.
authors.affiliation: Délégation à la recherche clinique et à l'innovation, CHU de Caen, 14033 Caen, France.
authors.forename: Henri
authors.initials: H
authors.lastname: Marfin
authors.affiliation: Centre régional de pharmacovigilance, CHU de Caen, 14033 Caen, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Fedrizzi
authors.affiliation: Service de pharmacologie-toxicologie et pharmacovigilance, CHU de limoges, 87042 Limoges, France.
authors.forename: Sabrina
authors.initials: S
authors.lastname: Crépin
authors.affiliation: Délégation à la recherche clinique et à l'innovation, CHU de Caen, 14033 Caen, France.
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Parienti
authors.affiliation: Délégation à la recherche clinique et à l'innovation, CHU de Bordeaux, 33404 Talence, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Gimbert
authors.affiliation: Délégation à la recherche clinique et à l'innovation, CHU de Caen, 14033 Caen, France.
authors.forename: Violaine
authors.initials: V
authors.lastname: Blandamour
authors.affiliation: ANRS, Inserm, 75013 Paris, France.
authors.forename: Alpha
authors.initials: A
authors.lastname: Diallo
authors.affiliation: Service de neurologie, CHU de Caen, 14033 Caen, France; Inserm U 919, GIP Cyceron, 14033 Caen, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Defer
authors.affiliation: Délégation à la recherche clinique et à l'innovation, hospices civils de Lyon, 69229 Lyon, France.
authors.forename: Delphine
authors.initials: D
authors.lastname: Bertram
authors.affiliation: Délégation à la recherche clinique et à l'innovation, CHU de Caen, 14033 Caen, France. Electronic address: peyrosaintpaul-l@chu-caen.fr.
authors.forename: Laure
authors.initials: L
authors.lastname: Peyro Saint Paul
mesh_terms: D002986:Clinical Trials as Topic; D064420:Drug-Related Side Effects and Adverse Reactions; D005602:France; D017408:Guidelines as Topic; D006801:Humans; D061214:Patient Safety; D011785:Quality Assurance, Health Care
keywords: Clinical trial; Essai clinique; Guideline; Harms; Ligne directrice; Publication; Reporting; Risques; Vigilance