Reporting Compliance of Stroke Trials: Cross-Sectional Analysis.
BACKGROUND
The FDA mandates timely reporting of all clinical trials conducted in the United States. However, often the results are not reported in a timely manner, resulting in wastage of finite resources. We assessed the reporting of results of completed stroke trials and compared the reporting trends between U.S. and non-U.S. stroke trials.


METHODS
We assessed consecutive clinical stroke trials registered as completed in ClinicalTrials.gov between January 1, 2008 and January 1, 2015. Descriptive data collected included study phase, study type, participant age, number of enrolled patients, study locations, start and primary completion dates, result availability, time to reporting (months), sponsorship, funding sources, and publication status. We also performed manual search for stroke trials in Pubmed, Web of Science, and Google scholar.


RESULTS
Out of a total 140 completed trials, 39 trials (35,359 patients) involved at least 1 U.S. center and 101 trials (58,542 patients) were conducted in non-U.S. centers. Of the trials involving at least a single U.S. center, 31 of 39 (79%) reported their results, whereas only 6 of 31 (19%) reported their results within 1 year. Of the trials conducted at non-U.S. centers, 72 of 101 (71%) reported their results, whereas results for 24 of 72 (33%) trials were available within a year of completion. The time to reporting of results was significantly lower for all the included clinical trials in the 2012-2014 period (P < .001, Cohen's d = .726) as compared to the 2008-2011 period.


CONCLUSION
Only one-fifth of completed stroke trials involving at least a single U.S. center report their results within 1 year. Additionally, every fifth completed trial involving stroke patients at U.S. centers remain unreported.
['Malhotra|Konark|K|', 'Rayi|Appaji|A|', 'Khunger|Monica|M|', 'Thompson|Stephanie|S|', 'Liebeskind|David S|DS|']
D022126:Access to Information D002986:Clinical Trials as Topic D003430:Cross-Sectional Studies D016208:Databases, Factual D019983:Guideline Adherence D017408:Guidelines as Topic D006801:Humans D012042:Registries D012107:Research Design D020521:Stroke D013997:Time Factors D016896:Treatment Outcome D014481:United States
stroke clinical trials Clinicaltrials.gov NIH database