Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis.

ABSTRACT:

Background

We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs.

Methods and findings

We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from

SUBMITTER: Speich B 

PROVIDER: S-EPMC9094518 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature