Half of trials with results posted in ClinicalTrials.gov database have not been published in a journal, and for some that have, the database contains more information
The trial registry ClinicalTrials.gov, which permits posting of trial results, includes results of some trials that have not been published in a peer-reviewed journal and in some cases includes more information than published trials, according to Carolina Riveros (INSERM, Paris, France) and colleagues, authors of a PLOS Medicine study published this week. The researchers searched ClinicalTrials.gov on March 2012 for randomized controlled trials of drugs with posted results. They selected 594 of these trials at random and searched PubMed for corresponding publications. Of the trials, 297 (50%) had no corresponding published article, despite the unpublished trials having a median year of completion of 2009.
Some outcomes were significantly more likely to be posted on ClinicalTrials.gov than published in the article; these were flow of participants (64% [129/202] vs. 48% [96/202] of trials, p<0.001), efficacy results (79% [159/202] vs. 69% [140/202], p=0.02), adverse events (73% [147/202] vs. 45% [91/202], p<0.001) and serious adverse events (99% [199/202] vs. 63% [127/202], p<0.001).
The authors state, “Our results have important implications for several stakeholders: patients and clinicians, authors, researchers performing systematic reviews and meta-analyses, methodologists, peer reviewers, developers of reporting guidelines and journal editors… our results outline the importance of registries to improve transparency in clinical research by making information about clinical trials including results publicly available, which is the basis for well-informed decision making about patients’ health.”
The authors acknowledge that unpublished trial results could be published at a future date; some trials may be submitted for publication several years after completion. They conclude, “our results highlight the importance of extracting efficacy and safety data posted at ClinicalTrials.gov for trials whose results are not yet published but also for those with published results because we found that reporting was more complete at ClinicalTrials.gov. Use of templates allowing for standardized reporting of trial results in journals or broader mandatory registration of results for all trials may help further improve transparency.”
Funding: Our team is supported by Grant No. DEQ20101221475, academic grant, program ”Equipe espoir de la Recherche”, Fondation pour la Recherche Médicale (FRM), Paris, France. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing Interests: IB is a member of the Editorial Board of PLOS Medicine. All other authors have declared that no competing interests exist.
Citation: Riveros C, Dechartres A, Perrodeau E, Haneef R, Boutron I, et al. (2013) Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals. PLoS Med 10(12): e1001566. doi:10.1371/journal.pmed.1001566
IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER:
Agnes Dechartres INSERM U738, APHP, University Paris 5 FRANCE email@example.com