Peer-Reviewed Publication
Clin Pharmacol Ther2026June 4, 2026Journal Article
Systematic Evaluation of Data and Trial Fitness for Oncology Trial Emulation: Empirical Findings from the CARE Initiative.
Natalie Levy1, Paige Sheridan1, Ulka Campbell1, David Lenis1, Inish O'Doherty1, Adina Estrin1, Nileesa Gautam1, Monica Iyer1, Sarah McDonald1, Andrew Belli2, Gillis Carrigan3, K Arnold Chan4, James Chen5, Victoria Chia3, Neil Dhopeshwarkar4, Joy Eckert6, Laura Fernandes2, Joel Greshock7, Rachele Hendricks-Sturrup8, Jenny Huang9, XiaoLong Jiao10, Sajan Khosla11, Orsolya Lunacsek12, Lynn McRoy10, Yanina Natanzon13, Osayi Ovbiosa14, Nelson Pace14, Simone Pinheiro14, Megan Rees15, Jennifer Rider13, Mothaffar Fahed Rimawi16, Travis Robinson15, Carla Rodriguez-Watson6, Chithra Sangli5, Khaled Sarsour7, Sebastian Schneeweiss17, Mark Shapiro18, Mark Stewart19, Aliki Taylor9, C K Wang2, Shirley Wang17, Yiduo Zhang11, Ann Madsen1
1Aetion, Inc, New York, New York, USA.
2COTA Healthcare, New York, New York, USA.
3Center for Observational Research, Amgen, San Francisco, California, USA.
4TriNetX, LLC, Cambridge, Massachusetts, USA.
5Tempus, Chicago, Illinois, USA.
6Reagan-Udall Foundation for the Food and Drug Administration, Washington, DC, USA.
7Johnson and Johnson, New Brunswick, New Jersey, USA.
8Duke-Margolis Center for Health Policy, Washington, DC, USA.
9Gilead Sciences, Foster City, California, USA.
10Pfizer, New York City, New York, USA.
11AstraZeneca, Gaithersburg, Maryland, USA.
12Bayer, Whippany, NJ, USA.
13ConcertAI, Cambridge, Massachusetts, USA.
14AbbVie, North Chicago, Illinois, USA.
15Loopback Analytics, Dallas, Texas, USA.
16Baylor College of Medicine, Houston, Texas, USA.
17Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
18xCures, Oakland, California, USA.
19Friends of Cancer Research, Washington, DC, USA.
Abstract
The Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation (CARE) Initiative seeks to advance understanding of when real-world data (RWD) can generate valid treatment effectiveness estimates by emulating completed oncology randomized controlled trials (RCTs). A prerequisite for meaningful RCT emulation insights is the identification and use of RWD with sufficient fi…
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