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

Trials

Volumn 21, Issue 1, 2020, Pages

  Talebi, Ramtin ^a   Redberg, Rita F ^a   Ross, Joseph S ^b,c,d  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c YALE UNIVERSITY   (United States)

^d YALE NEW HAVEN HOSPITAL   (United States)

Author keywords

Accurate reporting; Clinical trial reporting; FDA Amendments Act; Result reporting

Indexed keywords

ARTICLE; CHECKLIST; CONTROLLED STUDY; CROSS-SECTIONAL STUDY; EDITOR; HUMAN; PHASE 3 CLINICAL TRIAL; FOOD AND DRUG ADMINISTRATION; METHODOLOGY; PHASE 3 CLINICAL TRIAL (TOPIC); REGISTER; RESEARCH; UNITED STATES;

CLINICAL TRIALS, PHASE III AS TOPIC; CROSS-SECTIONAL STUDIES; HUMANS; REGISTRIES; RESEARCH DESIGN; RESEARCH REPORT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85088534658     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-020-04603-9     Document Type: Article

References (4)

1. Food and Drug Administration Amendments Act of 2007. (Public Law No. 110-85 § 801;2007.).
2. Becker JE, Krumholz HM, Ben-Josef G, Ross JS. Reporting of results in ClinicalTrials.gov and high-impact journals. JAMA. 2014;311(10):1063-5. https://doi.org/10.1001/jama.2013.285634.
3. Hartung DM, Zarin DA, Guise J, McDonagh M, Paynter R, Helfand M. Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. Ann Intern Med. 2014;160:477-83. https://doi.org/10.7326/M13-0480.
4. Chen T, Li C, Qin R, et al. Comparison of clinical trial changes in primary outcome and reported intervention effect size between trial registration and publication. JAMA Netw Open. 2019;2(7):e197242. https://doi.org/10.1001/jamanetworkopen.2019.7242.