title: Role of a research ethics committee in follow-up and publication of results.
abstract: Follow-up of clinical trials is a commitment rarely fulfilled by research ethics committees (RECs). We assessed the output of clinical trials submitted in 1997 to our REC, and talked to principal investigators, sponsors, contract research organisations, or a combination of these. During 1997, our REC reviewed 166 clinical trials, and approved 158. The recruitment rate was lower than expected in 45% (64/143) of all initiated clinical trials; 64% (92/143) were finished in accordance with protocol. 3 years after, the results of only 21% (26/123) of finished clinical trials were published in peer-reviewed journals, rising to 31% (38/123) if in-press articles were included. RECs should devote more effort and resources to assess public dissemination of results of clinical trials.
authors.affiliation: Clinical Pharmacology Unit, Hospital Clínic, Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
authors.forename: Judit
authors.initials: J
authors.lastname: Pich
authors.forename: Xavier
authors.initials: X
authors.lastname: Carné
authors.forename: Joan-Albert
authors.initials: JA
authors.lastname: Arnaiz
authors.forename: Begoña
authors.initials: B
authors.lastname: Gómez
authors.forename: Antoni
authors.initials: A
authors.lastname: Trilla
authors.forename: Juan
authors.initials: J
authors.lastname: Rodés
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D028744:Ethics Committees, Research / Q000592:standards*; D006801:Humans; D010506:Periodicals as Topic; D011642:Publications