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Role of a research ethics committee in follow-up and publication of results

Authors :
Joan-Albert Arnaiz
Xavier Carné
Begoña Gómez
Juan Rodés
Antoni Trilla
Judit Pich
Source :
The Lancet. 361:1015-1016
Publication Year :
2003
Publisher :
Elsevier BV, 2003.

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.

Details

ISSN :
01406736
Volume :
361
Database :
OpenAIRE
Journal :
The Lancet
Accession number :
edsair.doi...........7e8e67f18048e4664855a9cd98bc4315
Full Text :
https://doi.org/10.1016/s0140-6736(03)12799-7