{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["118(6)"],"submitter":["Su L"],"pubmed_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 = "],"journal":["Clinical pharmacology and therapeutics"],"pagination":["1350-1365"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12641079"],"repository":["biostudies-literature"],"pubmed_title":["Clinical Trials With Pragmatic Elements: A Review of Use Cases and Real-World Data Utilization."],"pmcid":["PMC12641079"],"pubmed_authors":["Hendricks-Sturrup R","Dreyer N","Chen L","Gardarsdottir H","Su L","Burcu M","Betigeri S"],"additional_accession":[]},"is_claimable":false,"name":"Clinical Trials With Pragmatic Elements: A Review of Use Cases and Real-World Data Utilization.","description":"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 = ","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Dec","modification":"2026-06-05T16:54:09.613Z","creation":"2026-06-05T03:06:28.105Z"},"accession":"S-EPMC12641079","cross_references":{"pubmed":["40827586"],"doi":["10.1002/cpt.70033"]}}