TY - JOUR
T1 - RReACT goes global
T2 - Perils and pitfalls of constructing a global open-access database of registered analgesic clinical trials and trial results
AU - Munch, Troels
AU - Dufka, Faustine L.
AU - Greene, Kaitlin
AU - Smith, Shannon M.
AU - Dworkin, Robert H.
AU - Rowbotham, Michael C.
N1 - Funding Information:
This work was supported by a research subaward from the U.S. Food and Drug Administration (FDA) U101 FD004187-02 (University of Rochester, R. Dworkin, PI), Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the FDA.
PY - 2014/7
Y1 - 2014/7
N2 - 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.
AB - 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.
KW - Clinical trial registries
KW - Clinical trials
KW - Databases
KW - Open-access
KW - Publication bias
KW - Transparency in research
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U2 - 10.1016/j.pain.2014.04.007
DO - 10.1016/j.pain.2014.04.007
M3 - Article
C2 - 24726925
AN - SCOPUS:84902331730
SN - 0304-3959
VL - 155
SP - 1313
EP - 1317
JO - Pain
JF - Pain
IS - 7
ER -