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Poor compliance of clinical trial registration among trials included in systematic reviews: a cohort study.

Authors
  • Lindsley, Kristina1
  • Fusco, Nicole2
  • Teeuw, Hannah3
  • Mooij, Eva3
  • Scholten, Rob4
  • Hooft, Lotty4
  • 1 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Life Sciences, IBM Watson Health, Baltimore, MD, USA. Electronic address: [email protected] , (Netherlands)
  • 2 Life Sciences, IBM Watson Health, Baltimore, MD, USA.
  • 3 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. , (Netherlands)
  • 4 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. , (Netherlands)
Type
Published Article
Journal
Journal of clinical epidemiology
Publication Date
Dec 14, 2020
Volume
132
Pages
79–87
Identifiers
DOI: 10.1016/j.jclinepi.2020.12.016
PMID: 33333165
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

The objective of the study was to examine whether clinical trials that have been included in systematic reviews have been registered in clinical trial registers and, when they have, whether results of the trials were included in the clinical trial register. This study used a sample of 100 systematic reviews published by the Cochrane Musculoskeletal, Oral, Skin and Sensory Network between 2014 and 2019. We identified 2,000 trials (369,778 participants) from a sample of 100 systematic reviews. The median year of trial publication was 2007. Of 1,177 trials published in 2005 or later, a clinical trial registration record was identified for 368 (31%). Of these registered trials, 135 (37%) were registered prospectively and results were posted for 114 (31%); most registered trials evaluated pharmaceutical interventions (62%). Of trials published in the last 10 years, the proportion of registered trials increased to 38% (261 of 682). Although some improvement in clinical trial registration has been observed in recent years, the proportion of registered clinical trials included in recently published systematic reviews remains less than desirable. Prospective clinical trial registration provides an essential role in assessing the risk of bias and judging the quality of evidence in systematic reviews of intervention safety and effectiveness. Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

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