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

• Published in: Journal of clinical epidemiology 2021-04, Vol.132, p.79-87
• Main Authors: Lindsley, Kristina, Fusco, Nicole, Teeuw, Hannah, Mooij, Eva, Scholten, Rob, Hooft, Lotty
• Format: Article
• Language: English
• Subjects: Bias; Clinical trials; Cohort analysis; Data collection; Epidemiology; Evidence synthesis; Intervention; Open access; Public domain; Randomized controlled trial; Registration; Reviews; Risk assessment; Systematic review; Trial registration
• ISSN: 0895-4356; 1878-5921
• DOI: 10.1016/j.jclinepi.2020.12.016

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. •Less than one-third of clinical trials in a sample of systematic reviews were registered.•Only 37% of registered trials were registered prospectively.•Only 31% of registered trials provided trial results with the registration record.•Some improvement in clinical trial registration recently, but still less than ideal.•More stringent enforcement of prospective clinical trial registration is needed.