In April this year, the World Health Organisation (WHO) issued a statement on the public disclosure of clinical trial results (the full statement is available from http://www.who.int/ictrp/results/reporting/en/). In essence, this statement reiterates the previous WHO statement on registration of trial methods prior to initiation and extends it to include the timely publication of results, both in clinical trial registries and in peer reviewed journals. The aim is to ensure that negative results are not underreported, thereby distorting efficacy conclusions derived from publicly available data. The statement also calls for sponsors to make the results of past trials available. Finally, the statement suggests more rigorous identification of trial registry identification in subsequent publications and data sharing initiatives, presumably to make meta-analyses easier. The statement was accompanied by a detailed rationale published in PLoS1 and a commentary, also in PLoS,2 by Ben Goldacre, a prominent campaigner for full disclosure of clinical trial results.
You must be a member of EMWA in order to download the full article.
EMWA members please log in to download the full article.
If you would like to become a member of EMWA, please join here.
Editor-in-Chief:
Co-Editor:
Managing Editor
Associate Editors:
Section Editors:
Ad-hoc Editors:
Editor Emeritus: