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Discrepancies ID’d in Studies on ClinicalTrials.gov, Journals

Last Updated: March 11, 2014.

 

Nearly all clinical trials have at least one discrepancy in cohort, intervention, or results

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Nearly all clinical trials reported on ClinicalTrials.gov and published in high-impact journals report at least one discrepancy in cohort, intervention, or results, according to a research letter published in the March 12 issue of the Journal of the American Medical Association.

TUESDAY, March 11, 2014 (HealthDay News) -- Nearly all clinical trials reported on ClinicalTrials.gov and published in high-impact journals report at least one discrepancy in cohort, intervention, or results, according to a research letter published in the March 12 issue of the Journal of the American Medical Association.

Jessica E. Becker, from the Yale University School of Medicine in New Haven, Conn., and colleagues conducted a cross-sectional analysis and compared clinical trial information and results reported on ClinicalTrials.gov with corresponding peer-reviewed publications.

The researchers identified 96 trials that reported results on ClinicalTrials.gov and were published in 19 high-impact journals, 73 percent of which had industry as the lead funder. At least one discordance among reported trial information or reported results was identified in 93 of these trials. Discordance varied from 2 to 22 percent for trials reporting each cohort characteristics and trial intervention information, and was highest for completion rate and trial intervention. Eighty-five percent of the 156 primary efficacy end points included in 91 trials were described in both sources, and results for 16 percent of these were discordant. Fifty-two percent of primary efficacy end points were described in both sources and were concordant.

"Among clinical trials published in high-impact journals that reported results on ClinicalTrials.gov, nearly all had at least one discrepancy in the cohort, intervention, or results reported between the two sources, including many discordances in reported primary end point," the authors write.

Several authors disclosed financial ties to Medtronic and/or UnitedHealthcare.

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