Work

Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA

Year: 2020

Type: article

Abstract: 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.

Source: Trials

DOI: 10.1186/s13063-020-04603-9

Authors: Ramtin Talebi, Rita F. Redberg, Joseph S. Ross

Institutions: University of California, San Francisco, University of California San Francisco Medical Center, Yale New Haven Hospital, Yale University

Language: English

Topic: Meta-analysis and systematic reviews

Subfield: Statistics, Probability and Uncertainty

Field: Decision Sciences

Domain: Social Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,190