Research waste among randomized clinical trials in endoscopic resection of gastrointestinal lesions: a cross-sectional study of ClinicalTrials.gov

To determine the association between the characteristics of randomized clinical trials (RCTs) on endoscopic resection and research waste, and to explore potential targets for improvement. ClinicalTrials.gov was searched for phase 3 or 4 RCTs registered between January 01,2000 and December 31, 2021 using the keyword endoscopic resection along with synonyms. The publication status was determined by conducting systematic searches in the PubMed and Google Scholar databases. The adequacy of reporting was assessed using the Consolidated Standards of Reporting Trials (CONSORT) Reporting Guideline Checklist. Design limitations were evaluated based on risk of bias and whether the manuscript cited a relevant systematic review. The primary outcome was research waste, defined as unpublished data, inadequate reporting, or avoidable design limitations. A total of 86 trials were included. Only 47 (54.7%) RCTs were published after peer review. These trials were more likely than unpublished RCTs to focus on colorectal disease (68.1% vs. 35.9%, P = 0.003) and to have a multicenter design (44.7% vs. 25.6%, P = 0.067). Among the RCTs that were published, 24 (51.1%) of them were deemed to have sufficient reporting and were free from any design limitations. Overall, 70 of the 86 RCTs (81.4%) exhibited research waste. Multivariate analysis revealed that a blinded (P = 0.021) and multicenter (P = 0.017) RCT design independently reduced the risk of research waste. Most RCTs on endoscopic resection of gastrointestinal lesions could be burdened by research waste. Efforts should focus on improving unblinded, single-center RCTs to reduce unnecessary research waste.