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Lancet. 2003 Mar 22;361(9362):1015-6.

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

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1
Clinical Pharmacology Unit, Hospital Clínic, Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.

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.

PMID:
12660062
DOI:
10.1016/S0140-6736(03)12799-7
[Indexed for MEDLINE]
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