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

Munch, Troelsa,b; Dufka, Faustine L.a; Greene, Kaitlina; Smith, Shannon M.c; Dworkin, Robert H.c; Rowbotham, Michael C.a,*

doi: 10.1016/j.pain.2014.04.007
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Summary Identifying analgesic trials listed on multiple registries and pairing trials with results is challenging. Trials on ClinicalTrials.gov are significantly more likely to have available 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.

aCalifornia Pacific Medical Center Research Institute, San Francisco, CA 94107, USA

bDepartment of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen 2100, Denmark

cUniversity of Rochester School of Medicine and Dentistry, Rochester, NY 14642, USA

* Corresponding author. Address: California Pacific Medical Center Research Institute, 475 Brannan Street, Suite 220, San Francisco, CA 94107, USA. Tel.: +1 415 600 1750; fax: +1 415 600 1725.

E-mail address:rowbotm@cpmcri.org

Article history:

Received February 14, 2014

Received in revised form March 29, 2014

Accepted April 4, 2014

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

© 2014 International Association for the Study of Pain
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