Clinical Trial Registration Patterns and Changes in Primary Outcomes of Randomized Clinical Trials From 2002 to 2017
Lamberink, Herm J; Vinkers, Christiaan H; Lancee, Michelle; Damen, Johanna A A; Bouter, Lex M; Otte, Willem M; Tijdink, Joeri K
(2022) JAMA Internal Medicine, volume 182, issue 7, pp. 779 - 782
(Letter)
Abstract
This cross-sectional study evaluates the existence and timing of trial registration for randomized clinical trials (RCTs) published from 2002 to 2017 as well as substantive changes to the primary outcomes entered into registry information after those studies started.
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Keywords: Humans, Randomized Controlled Trials as Topic, Registries, Journal Article, Research Support, Non-U.S. Gov't
ISSN: 2168-6106
Publisher: American Medical Association
Note: Funding Information: Conflict of Interest Disclosures: None reported. Funding/Support: This study was funded by grant ZonMW 445001002 from the Netherlands Organisation for Health Research and Development. Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Additional Contributions: Lotty Hooft, PhD, Cochrane Netherlands, contributed to the study design. Master’s students Isabelle M.L.P. Kamm, BSc, and Marissa J.M. Traets, MD, Cochrane Netherlands, manually checked the changes in the primary outcome. These individuals received no additional compensation, outside of their usual salary, for their contributions.
(Peer reviewed)