Analysis of Research Waste in Phase III/IV Randomized Controlled Trials of Botulinum Toxin Type A.

Abstract

Background: The application of randomized controlled trials (RCTs) outcomes of botulinum toxin type A (BoNT-A) to actual patient care faces a significant hurdle due to research waste (RW). This includes the results of RCTs that have not been published even 4 years after completion and those with insufficiently reported outcomes and design flaws. The prevalence of RW within BoNT-A-associated RCTs remains uncertain.

Objective: To assess the extent of RW (non-publication, insufficient reporting, and design flaws) in BoNT-A RCTs.

Methods: The authors searched the ClinicalTrials using 'botulinum toxin type A' as the keyword. They verified the publication status through PubMed and Scopus searches. The adequacy of reporting was assessed using the Consolidated Standards of Reporting Trials checklist, while design limitations were evaluated based on the risk of bias and systematic reviews.

Results: Two hundred twenty-eight RCTs met the inclusion criteria for characteristics presentation. The RW analysis omitted 53 RCTs completed after June 2020, which remained unpublished. Of the 175 RCTs assessed, 98 were published, 71 demonstrated adequate reporting, and 25 had design limitations. Altogether, 118 RCTs (67.4%) exhibited at least 1 trait of RW. Multicenter designs and registrations post-2014 were independent protective factors against RW.

Conclusion: Within the 175 RCTs included in RW analysis, 67.4% of the studies presented some form of RW. The varied characteristics of the identified RW indicators offer essential insights for more rational planning of future BoNT-A RCTs.