Peer-Reviewed Publication
Clin Pharmacol Ther2026October 5, 2026Journal Article
Considerations for the Integration of Clinical Trials and Real-World Data.
Sky Qiu1,2,3, Charles E Barr4, Lauren Dang5, Larry Han6,7, Kajsa Kvist8, Hana Lee9, Andrew Mertens2,10, Nerissa Nance2,8, Lei Nie9, Kara Rudolph11, Xu Shi12, Jens Tarp8, Salina P Waddy13, Kenneth Wiley13, Andy Wilson14,15, Margot Lisa Jing Yann16, Zhiwei Zhang17, Tianyue Zhou1,2, Maya Petersen1,2, Mark van der Laan1,2
1Division of Biostatistics, School of Public Health, University of California, Berkeley, California, USA.
2Center for Targeted Machine Learning and Causal Inference, School of Public Health, University of California, Berkeley, California, USA.
3Targeted ML Solutions, Inc., Cambridge, Massachusetts, USA.
4Adaptic Health, Mountain View, California, USA.
5National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.
6Department of Public Health and Health Sciences, Northeastern University, Boston, Massachusetts, USA.
7Department of Biostatistics, School of Public Health, Brown University, Providence, Rhode Island, USA.
8Novo Nordisk A/S, Bagsvaerd, Denmark.
9Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
10Division of Epidemiology and Biostatistics, School of Public Health, University of California, Berkeley, California, USA.
11Department of Epidemiology, Columbia University Mailman School of Public Health, New York City, New York, USA.
12Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.
13National Institutes of Health, Bethesda, Maryland, USA.
14University of Utah, Salt Lake City, Utah, USA.
15Tao of RWD, Salt Lake City, Utah, USA.
16Forum for Collaborative Research, School of Public Health, University of California, Berkeley, California, USA.
17Gilead Sciences, Foster City, California, USA.
Abstract
As clinical decision-making increasingly moves toward individualized and context-specific treatment recommendations, reliance on any single evidence source, randomized or observational, may be insufficient. Principled integration of randomized controlled trials and real-world data, grounded in explicit causal frameworks, offers a path toward evidence that is both internally credible and externally…
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