Recent innovations in adaptive trial designs: A review of design opportunities in translational research.

ABSTRACT: Clinical trials are constantly evolving in the context of increasingly complex research questions and potentially limited resources. In this review article, we discuss the emergence of "adaptive" clinical trials that allow for the preplanned modification of an ongoing clinical trial based on the accumulating evidence with application across translational research. These modifications may include terminating a trial before completion due to futility or efficacy, re-estimating the needed sample size to ensure adequate power, enriching the target population enrolled in the study, selecting across multiple treatment arms, revising allocation ratios used for randomization, or selecting the most appropriate endpoint. Emerging topics related to borrowing information from historic or supplemental

SUBMITTER: Kaizer AM 

PROVIDER: S-EPMC10260347 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature