Journal
TRIALS
Volume 21, Issue 1, Pages -Publisher
BMC
DOI: 10.1186/s13063-020-04603-9
Keywords
FDA Amendments Act; Clinical trial reporting; Result reporting; Accurate reporting
Categories
Funding
- Harvard Global Health Institute Cordeiro Fellowship
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The FDA Amendments Act (FDAAA) required that information for certain clinical trials, such as details about study design features and endpoints, as well as results, be publicly reported in ClinicalTrials.gov. We conducted a cross-sectional analysis of phase III trials with primary results published between January 1, 2016, and June 30, 2017, in high-impact journals and found 74% contained at least one discrepancy between results reported in ClinicalTrials.gov and the corresponding publication. Our findings underscore the necessity for monitoring of clinical trial information and result reporting between sources; a checklist may provide a systemized procedure for investigators and editors to monitor accurate reporting.
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