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

被引:75
作者
Pich, J
Carné, X
Arnaiz, JA
Gómez, B
Trilla, A
Rodés, J
机构
[1] Hosp Clin Barcelona, IDIBAPS, Clin Pharmacol Unit, Barcelona, Spain
[2] Hosp Clin Barcelona, IDIBAPS, Assessment Support & Prevent Unit, Barcelona, Spain
[3] Hosp Clin Barcelona, IDIBAPS, Res Direct, Barcelona, Spain
关键词
D O I
10.1016/S0140-6736(03)12799-7
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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% (26/1.23) 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.
引用
收藏
页码:1015 / 1016
页数:2
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