What is the Accuracy of Trial Results Reported on ClinicalTrials.gov and in Journals?
When comparing trial information and results reported on ClinicalTrials.gov with corresponding peer-reviewed publications, nearly all trials had at least one discrepancy reported between the two sources, according to a research letter published March 11 in the Journal of the American Medical Association. In particular, there were "many discordances in reported primary end points."
The researchers, led by Jessica E. Becker, AB, Yale University School of Medicine, New Haven, CT, conducted a cross-sectional analysis of 96 clinical trials with primary results published in 19 high-impact journals between July 1, 2010 and June 30, 2011, and reported on ClinicalTrials.gov. Results showed that 93 of the 96 trials "had at least one discordance among reported trial information or reported results." Further, among trials reporting each cohort characteristic and trial intervention information, "discordance ranged from 2 percent to 22 percent and was highest for completion rate and trial intervention, for which different descriptions of dosages, frequencies, or duration of intervention was common."
In addition, there were a total of 156 primary efficacy end points defined in 91 trials; and 132 primary efficacy end points (85 percent) were described in both sources, 14 (9 percent) were only described on ClinicalTrials.gov, and 10 (6 percent) were only described in publications. The majority of discordant end point results did not alter the trial interpretation; however, for six of the end points, the discordance did alter the trial interpretation.
These findings "raise questions about accuracy of both ClinicalTrials.gov and publications, as each source's reported results at times disagreed with the other," the letter notes. Moving forward, "further efforts are needed to ensure accuracy of public clinical trial result reporting efforts."
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