Characterization of medical device randomized controlled trials with adaptive designs.

ABSTRACT: Aim: Adaptive designs are frequently used in drug randomized controlled trials (RCTs). However, their use in medical device RCTs remains unclear. We aimed to characterize medical device RCTs with adaptive designs. Materials & methods: We searched for adaptive RCTs in the following databases: ClinicalTrials.gov, International Clinical Trials Registry Platform and the International Standard Randomised Controlled Trial Number registry. Adaptive design keywords and medical device corporation names were used as terms to search the trial records registered between 1 January 2000 and 18 October 2024 in the databases. The annual number and proportions of adaptive trials were analyzed, and characteristics such as design type, sponsor, therapeutic area, trial stage and regulatory statu

SUBMITTER: Su G 

PROVIDER: S-EPMC11650385 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature