The contribution and attitudes of research ethics committees to complete registration and non-selective reporting of clinical trials: A European survey

TitleThe contribution and attitudes of research ethics committees to complete registration and non-selective reporting of clinical trials: A European survey
Publication TypeJournal Article
Year of Publication2016
AuthorsStrech, D, Littmann, J, consortium, onbehalf of
JournalResearch Ethics
Volume12
Issue3
Pagination123-136
Date PublishedJuly 1, 2016
Publication Languageeng
AbstractBackground: For many years, studies have shown that the results of clinical trials are often published or reported selectively with a statistically significant bias in favour of positive trial results. Trial registration as a precondition for publication had only limited effects on current practice. Results of trials which were approved by research ethics committees (RECs) are often published only partially, with a substantial time lag or not at all. This study examined existing procedures of RECs in the European Union to monitor and prevent incomplete registration of trials and selective reporting of trial results. It further investigated opinions of REC members about the need to update current legislation on this matter. Methods: Web-based survey on members of RECs in 22 European countries. Results: Over 90 percent of respondents agreed that the incomplete publication of trial results had a strong or somewhat negative impact on public health and on healthcare professionals’ trust in the validity of clinical research, yet only 30 percent reported that their REC had some (often unsystematic) mechanism in place to check that findings of approved studies are published in some form. Less than 10 percent stated that their REC has further specific procedures in place to prevent or minimize selective reporting of study results. Respondents stated variously that their REC did not have the resources to follow up on this matter. Conclusions: The existing legislation to regulate trial registration and encourage complete publication of trial results leaves room for improvement. REC members welcome guidelines to adequately address both problems. The new Regulation EU No. 536/2014 as well as the FDA Amendment Act from 2007 require the reporting of summary results within 1 year after study end. As recent reviews demonstrated, without any systematic approach to monitor the adherence to these regulations, publication rates remain rather low.
URLhttp://rea.sagepub.com/cgi/content/abstract/12/3/123
DOI10.1177/1747016115626497

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