biostudies-literatureUnknown118(6)Su LClinical 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 = Clinical pharmacology and therapeutics1350-1365https://www.ebi.ac.uk/biostudies/studies/S-EPMC12641079biostudies-literatureClinical Trials With Pragmatic Elements: A Review of Use Cases and Real-World Data Utilization.PMC12641079Hendricks-Sturrup RDreyer NChen LGardarsdottir HSu LBurcu MBetigeri SfalseClinical Trials With Pragmatic Elements: A Review of Use Cases and Real-World Data Utilization.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 = 2025-01-01T00:00:00Z2025 Dec2026-06-05T16:54:09.613Z2026-06-05T03:06:28.105ZS-EPMC126410794082758610.1002/cpt.70033