Elsevier

The Lancet

Volume 365, Issue 9474, 28 May–3 June 2005, Pages 1829-1831
The Lancet

Comment
WHO facilitates international collaboration in setting standards for clinical trial registration

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    To that end, in 2004, the International Committee of Medical Journal Editors has recommended that all studies accepted for publication should have been prospectively registered and made their protocol publicly available [4]. In 2005, World Health Organization called on the scientific community to record and publicize all research protocols, and then announced the creation of the International Clinical Trial Registry Platform, where anyone could search for and retrieve any information about clinical trials organized and carried out [5]. Scientific tools to improve the quality of reporting of RCT protocols such as the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) have also been developed to inform scientific community about important design features of trials in a transparent and standardized manner [6].

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    Moreover, systematic reviewers obtain the protocol information of published studies from clinical trials registries [1]. ICTRP has evolved as a search portal of clinical trials registration and aggregated data of studies in national and regional registries all over the world since 2005 [2,3]. ClinicalTrials.gov was the largest of the 17 registries that sent data to the ICTRP as of 2013 [4] and owned 119,840 records of drug studies before 2015 [5].

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    However, phase 1 trials remain uncovered by the expanded FDAAA 801 requirements [36], which is of serious concern considering the fact that 59.4% of clinical trials on DDIs in our study with submitted and published results were in phase 1 and 81.6% of these trials had discrepancies in the reporting of SAEs or OAEs. Contrary to ICMJE [27] and WHO guidelines [46] for prospective registration, more than half of drug interaction trials were registered after enrollment of the first participant. Higher rates of adequate time of registration for FDAAA-covered trials than for ICMJE-covered (64.5% vs. 39.6%) could be explained by different definition of timely registration [16,27].

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