From registration, protocol to report: are COVID-19-related RCTs in mainland China consistent? A systematic review of clinical trial registry and literature.

ABSTRACT:

Objective

To provide a comprehensive review of registered COVID-19-related randomised controlled trials (RCTs) in mainland China and evaluate the transparency of reporting through comparison of registrations, protocols and full reports.

Design

Systematic review of trial registrations and publications.

Data sources

International Clinical Trials Registry Platform, Chinese Clinical Trial Registry, ClinicalTrials.gov, the ISRCTN registry and EU Clinical Trial Register were accessed on 1 February 2022. Publications were searched in PubMed, Embase, Cochrane Library, Google Scholar, CNKI.net and Wanfangdata from 10 February 2022 to 12 February 2022.

Eligibility criteria

Eligible trials were COVID-19 related RCTs carried out in mainland China. Observational studies, non-randomised trials and single-arm trials were excluded.

Data extraction and synthesis

Two reviewers independently extracted data from registrations, publications and performed risk of bias assessment for trial reports. Information provided by registrations and publications was compared. The findings were summarised with descriptive statistics.

Results

The number of eligible studies was 415. From these studies 20 protocols and 77 RCT reports were published. Seven trials published both protocol and RCT full report. Between registrations and publications, discrepancy or omission was found in sample size (7, 35.0% for protocols and 47, 61.0% for reports, same below), trial setting (13, 65.0% and 43, 55.8%), inclusion criteria (12, 60.0% and 57, 74.0%), exclusion criteria (10, 50.0% and 54, 70.1%), masking method (9, 45.0% and 35, 45.5%) and primary outcome or time frame of primary outcome measurement (14, 70.0% and 51, 66.2%). Between protocols and full reports, 5 (71.4%) reports had discrepancy in primary outcome or time frame of primary outcome measurement.

Conclusions

Discrepancy among registrations, protocols and reports revealed compromised transparency in reporting of COVID-19-related RCTs in mainland China. The importance of trial registration should be further emphasised to enhance transparent RCT reporting.

SUBMITTER: Chen Y 

PROVIDER: S-EPMC9309620 | biostudies-literature |

REPOSITORIES: biostudies-literature