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• W4235820747 abstract "Judit Pich and colleagues (March 22, p 1015)1Pich J Carné X Arnaiz JA Gómez B Trilla A Rodés J Role of a research ethics committee in follow-up and publication of results.Lancet. 2003; 361: 1015-1016Summary Full Text Full Text PDF PubMed Scopus (93) Google Scholar point out that follow-up of clinical trials is a commitment rarely fullfilled by research ethics committees (RECs). This fact contributes to the poor knowledge the scientific community has about the fate of clinical trials submitted, approved, and undertaken in our health centres. According to Mann,2Mann H Research ethics committees and public dissemination of clinical trial results.Lancet. 2002; 360: 406-408Summary Full Text Full Text PDF PubMed Scopus (56) Google Scholar dissemination of the results of clinical research is an important ethical postulate, which ethics committees,3The Royal Decree 561/1993 of April 16 establishing the requirements for the performance of clinical trials with medicines (in Spanish).BOE. May 3, 1993; : 14346-14363Google Scholar together with institutions, editors, and consumers, should enforce. Therefore, we decided to assess the outcome, with respect to publication of results in peer-reviewed journals, of the 217 officially closed clinical trials approved by our ethics committee between 1997 and 1999, using standard survival analysis techniques. We examined the effect of various factors— phase of development, scope, and medical specialty—on publication. We searched MEDLINE for published studies. Articles were also sent directly to us by our sponsors. Results of only 44 (20%) of the trials have been published after a median follow-up of 976 days (range 22–2175). Of those published, the median time from study end to publication was 505 days (70–1340). Findings of 26 (27%) of the phase 3 trials have been published, whereas those of only eight (19%) and ten (13%), phase 1 and 2, and phase 4 trials have been reported, respectively (p=0·043, using Cox-regression). Median time to publication was 720 days (range 203–1069), 472 days (137–1340), and 512 days (70–811) for phase 1 and 2, 3, and 4 trials, respectively. Results of international multicentre trials were twice as likely as national trials to be published (38, 24%, vs six, 11%; p=0·076), as were those of trials with non-registered rather than registered drugs (33, 24%, vs 11, 15%; p=0·139). We noted no significant differences in rate of publication dependent on specialty: cardiology (eight, 38%), paediatrics (three, 23%), neurology (four, 21%), hepatology (two, 20%), pneumology (three, 20%), and oncology (seven, 18%). However, cardiology trials were the most likely to be published and had the shortest median time to publication (201 days). The proportion of our trials published, therefore, is scarcely a fifth of all finished studies, which is a slightly lower rate than that noted by Pich and colleagues. Ethics committees should be encouraged to actively follow up finished clinical trials, to more thoroughly disseminate the results of clinical research." @default.
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• W4235820747 date "2003-06-01" @default.
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• W4235820747 title "Role of a research ethics committee in follow-up and publication of results" @default.
• W4235820747 doi "https://doi.org/10.1016/s0140-6736(03)13751-8" @default.
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