Research waste among randomized controlled trials in preterm infants: a Cross-sectional study.

Abstract

Objective: Randomized controlled trials (RCTs) are the gold standard for evaluating efficacy; however, they may contribute to research waste. This study examined the extent of research waste in RCTs involving preterm infants over the past two decades.

Methods: This cross-sectional study searched ClinicalTrials.gov between 2001 and 2020 to identify RCTs involving preterm infants. Research waste was defined as the occurrence of any of the following: non-publication, poor reporting, or avoidable design deficiencies. We searched PubMed, Embase, and Google Scholar databases to determine publication status. The CONSORT checklist was used to evaluate the reporting adequacy. Design deficiency was identified based on the risk of bias, evaluated using the Cochrane tool, and the presence of a relevant systematic review.

Results: A total of 100 RCTs were eligible for inclusion. The primary research focus was pulmonary diseases (28%), followed by nutritional (15%) and ophthalmological diseases. Seventy-eight of the 100 RCTs were published and these were likelier to have an enrollment size greater than 300 (26% vs. 5%, p = .038). Inadequate reporting was observed in 25 published RCTs, while 47 had design deficiencies. Overall, 69 of the 100 RCTs exhibited at least one feature of research waste. Having a primary investigator from North America or Europe (odds ratio [OR] 0.168, 95% confidence interval [CI] 0.040-0.711, p = .015) and an enrollment size greater than 300 (OR 0.074, 95% CI 0.018-0.304, p < .001) were independently associated with reduced research waste.

Conclusion: Nearly 70% of RCTs involving preterm infants exhibited features of research waste. However, large-scale RCTs conducted in North America and Europe were less likely to contribute to this issue.