Clinical Trials With Pragmatic Elements: A Review of Use Cases and Real-World Data Utilization.

ABSTRACT: Clinical trials with pragmatic elements can capture diverse patient populations, enable efficient follow-up, and reflect routine clinical practices; yet there is limited understanding of their design features, characteristics, and use of real-world data (RWD). Based on a targeted search of PubMed/EMBASE (Jan-2016 to Jul-2024), a review was conducted to characterize clinical trial use cases with pragmatic elements during the design and conduct of trials, as well as clinical trials that utilized RWD for long-term follow-up in the extension phase of the original ("parent") trial. A total of 27 use cases were characterized. There were 22 use cases with pragmatic elements, and nearly all employed randomization (n = 21, 95.5%), open-label design (n = 20, 90.9%), with usual/standard of care (n = 

SUBMITTER: Su L 

PROVIDER: S-EPMC12641079 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature