title: RReACT goes global: perils and pitfalls of constructing a global open-access database of registered analgesic clinical trials and trial results.
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.
authors.affiliation: California Pacific Medical Center Research Institute, San Francisco, CA 94107, USA Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen 2100, Denmark University of Rochester School of Medicine and Dentistry, Rochester, NY 14642, USA.
authors.forename: Troels
authors.initials: T
authors.lastname: Munch
authors.forename: Faustine L
authors.initials: FL
authors.lastname: Dufka
authors.forename: Kaitlin
authors.initials: K
authors.lastname: Greene
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Smith
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
authors.forename: Michael C
authors.initials: MC
authors.lastname: Rowbotham
mesh_terms: D022126:Access to Information; D000465:Algorithms; D002986:Clinical Trials as Topic; D016208:Databases, Factual; D003929:Diabetic Neuropathies; D005356:Fibromyalgia; D006801:Humans; D051474:Neuralgia, Postherpetic; D017594:Publication Bias; D012042:Registries
keywords: Clinical trial registries; Clinical trials; Databases; Open-access; Publication bias; Transparency in research
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