RReACT goes global: Perils and pitfalls of constructing a global open-access database of registered analgesic clinical trials and trial results

Troels Munch · Faustine L. Dufka · Kaitlin A. Greene · Shannon M. Smith · Robert H. Dworkin · Michael C. Rowbotham

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Meta-analysis and systematic reviews Academic Publishing and Open Access Pharmaceutical industry and healthcare

Abstract

Eliminating publication bias requires ensuring public awareness of studies and access to results. Clinical trial registries provide basic trial information, but access to unbiased trial results is inadequate. Nearly all studies of trial registration and results reporting have been limited to the ClinicalTrials.gov registry. We analyzed trial registration, registry functionality, cross-registry harmonization, and results reporting on all 15 primary registries in the World Health Organization International Clinical Trials Registry Platform (ICTRP) for postherpetic neuralgia, painful diabetic neuropathy, and fibromyalgia. A total of 447 unique trials were identified, with 86 trials listed on more than one registry. A comprehensive search algorithm was used to find trial results in the peer-reviewed literature and the grey literature. Creating a global database of registered trials and trial results proved surprisingly difficult for several reasons: (1) ICTRP does not reliably identify trials listed on multiple registries, manual searches are necessary; (2) Searching ICTRP yields different results than searching individual registries; (3) Outcome measure descriptions for multiply registered trials vary between registries; (4) Registry-publication pairings are often inaccurate or incomplete; (5) Grey literature results are not permanent. Overall, only 46% of all trials had results available. Trials registered on ClinicalTrials.gov were significantly more likely to have results (52% vs. 18%, P<0.001), partly due to the ability to post results directly to the registry. In addition to the simple remedy of including trial registration numbers on all meeting abstracts and peer-reviewed papers, specific strategies are offered to facilitate identifying multiply registered studies and ensuring accurate pairing of results and publications.

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2007Grey literature in meta-analyses of randomized trials of health care interventions 2010Reporting bias in medical research - a narrative review 2013"Hardly worth the effort"? Medical journals' policies and their editors' and publishers' views on trial registration and publication bias: quantitative and qualitative study 2013Linking ClinicalTrials.gov and PubMed to Track Results of Interventional Human Clinical Trials 2012Trial Registration Numbers Are Underreported in Biomedical Publications 2008The impact of selective publication on clinical research in pain

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