Work

Reporting of Results in ClinicalTrials.gov and High-Impact Journals

Year: 2014

Type: article

Abstract: Reporting of Results in ClinicalTrials.gov and High-Impact JournalsThe 2007 Food and Drug Administration (FDA) Amendments Act expanded requirements for ClinicalTrials.gov,a public clinical trial registry maintained by the National Library of Medicine, mandating results reporting within 12 months of trial completion for all FDA-regulated medical products.Reporting of mandatory trial registration information on ClinicalTrials.gov is fairly complete, although there are concerns about its specificity; optional trial registration information is less complete. 1-4To our knowledge, no studies have examined reporting and accuracy of trial results information.Accordingly, we compared trial information and results reported on ClinicalTrials.govwith corresponding peer-reviewed publications.

Source: JAMA

DOI: 10.1001/jama.2013.285634

Authors: Jessica E. Becker, Harlan M. Krumholz, Gal Ben-Josef, Joseph S. Ross

Institution: 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: green

Funders: National Institute on Aging, National Heart, Lung, and Blood Institute