Using the Cochrane Central Register of Controlled Trials to identify clinical trial registration is insufficient: a cross-sectional study

摘要

While conducting systemic reviews, searching for ongoing or unpublished trials is critical to address publication bias. As of April 2019, records of ongoing or unpublished randomized and/or quasi-randomized controlled trials registered in the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov are available in the Cochrane Central Register of Controlled Trials (CENTRAL). These records registered in CENTRAL include studies published since the inception of ICTRP and ClinicalTrials.gov . Whether systematic reviewers can search CENTRAL to identify ongoing or unpublished trials instead of ICTRP and ClinicalTrials.gov is unknown. This was a cross-sectional study. A consecutive sample of ongoing or unpublished studies published from June 1, 2019 to December 27, 2019 was selected from the Cochrane Reviews. The sensitivity and the number needed to read (NNR) were assessed from among the studies selected from CENTRAL instead of ICTRP and ClinicalTrials.gov and also assessed the characteristics of studies not identified by searching CENTRAL. In total, 247 records from 50 Cochrane reviews were included; of these, 200 were identified by searching CENTRAL, whereas the remaining 47 records were not. The sensitivity of searching CENTRAL was 0.81 (95% confidence interval [CI]: 0.76, 0.85). The NNR was 115 (95% CI: 101, 133). The 47 unidentified studies were registered through ClinicalTrials.gov or ICTRP. Sixteen unidentified studies were not indexed in CENTRAL. For systematic reviewers, searching CENTRAL could not substitute for searching ClinicalTrials.gov and/or ICTRP. Systematic reviewers should not only search CENTRAL but also ICTRP and ClinicalTrials.gov to identify unpublished trials. A pre-specified protocol was applied to conduct this study. The study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). Trial registration number: UMIN000038981 .