TY - JOUR
T1 - A comparison of registered and published primary outcomes in clinical trials of opioid use disorder
T2 - ACTTION review and recommendations
AU - Kleykamp, Bethea A.
AU - Ferguson, McKenzie C.
AU - McNicol, Ewan
AU - Bixho, Ida
AU - Matthews, Michele
AU - Turk, Dennis C.
AU - Dworkin, Robert H.
AU - Strain, Eric C.
N1 - Funding Information:
Financial support for this review was provided by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration ( FDA ) ( U01-FD005936 ), which has received research grants, contracts, and other support from the FDA, multiple pharmaceutical and device companies, philanthropy, royalties, and other sources (a list of ACTTION's industry sponsors is available at http://www.acttion.org/partners).
Publisher Copyright:
© 2022 Elsevier B.V.
PY - 2022/7/1
Y1 - 2022/7/1
N2 - Background and Aims: Prospective trial registration can increase research integrity. This Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) review was designed to compare the primary outcomes (PO) reported in registries with associated publications for opioid use disorder (OUD) clinical trials. Design: The World Health Organization's International Clinical Trials Registry Platform (ICTRP) was searched for completed trials (2010 through 2019). Associated publications were identified and paired with trial registry data based on the publication date. Measurements: Reviewers independently rated the occurrence of discrepancies between the POs in the registry compared to the publication. An analysis of prospective versus retrospective registration was also completed. Findings: One-hundred and forty trials were identified in the search, and 43 registry-publication pairs evaluated. Only 34 of the 43 pairs could be examined for discrepancies because nine did not report a PO in registry and publication. Of the 34 pairs, only four met rigorous criteria for prospective trial registration and had an exact match of POs. In contrast, the majority of the 34 trials, or 80%, had inconsistent POs (e.g., registered secondary outcomes published as primary; the timing of PO not specified) and/or were retrospectively registered. Conclusions: Many clinical trials focused on OUD have not met the standards of trial registration, such as consistent reporting of POs and prospective registration. Failure to properly register trial characteristics undermines the validity of research findings and can delay the development of life-saving treatments. Recommendations for improving prospective trial reporting practices are provided.
AB - Background and Aims: Prospective trial registration can increase research integrity. This Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) review was designed to compare the primary outcomes (PO) reported in registries with associated publications for opioid use disorder (OUD) clinical trials. Design: The World Health Organization's International Clinical Trials Registry Platform (ICTRP) was searched for completed trials (2010 through 2019). Associated publications were identified and paired with trial registry data based on the publication date. Measurements: Reviewers independently rated the occurrence of discrepancies between the POs in the registry compared to the publication. An analysis of prospective versus retrospective registration was also completed. Findings: One-hundred and forty trials were identified in the search, and 43 registry-publication pairs evaluated. Only 34 of the 43 pairs could be examined for discrepancies because nine did not report a PO in registry and publication. Of the 34 pairs, only four met rigorous criteria for prospective trial registration and had an exact match of POs. In contrast, the majority of the 34 trials, or 80%, had inconsistent POs (e.g., registered secondary outcomes published as primary; the timing of PO not specified) and/or were retrospectively registered. Conclusions: Many clinical trials focused on OUD have not met the standards of trial registration, such as consistent reporting of POs and prospective registration. Failure to properly register trial characteristics undermines the validity of research findings and can delay the development of life-saving treatments. Recommendations for improving prospective trial reporting practices are provided.
KW - Bias
KW - ClinicalTrials.gov
KW - Opioid use disorder
KW - Trial registration
UR - http://www.scopus.com/inward/record.url?scp=85130354040&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85130354040&partnerID=8YFLogxK
U2 - 10.1016/j.drugalcdep.2022.109447
DO - 10.1016/j.drugalcdep.2022.109447
M3 - Review article
C2 - 35580477
AN - SCOPUS:85130354040
SN - 0376-8716
VL - 236
JO - Drug and Alcohol Dependence
JF - Drug and Alcohol Dependence
M1 - 109447
ER -