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Invited Commentary
July 28, 2021

Extrapolating Survival From Randomized Clinical Trial Data—Possibilities and Caution

Author Affiliations
  • 1Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina
  • 2Duke Clinical Research Institute, Durham, North Carolina
  • 3Associate Editor for Statistics, JAMA Cardiology
  • 4Department of Cardiology, University of Texas Southwestern Medical School, Dallas
  • 5Associate Editor, JAMA Cardiology
JAMA Cardiol. Published online July 28, 2021. doi:10.1001/jamacardio.2021.2629

Many therapies in cardiovascular disease, including heart failure (HF), are studied in clinical trials that report hazard ratios (HRs) over a follow-up period far shorter than the anticipated treatment duration. The HR has known limitations, and alternative measures, such as restricted mean survival time, have been advocated to summarize survival over limited follow-up.1 However, in chronic diseases, such as HF, treatment effect measures, such as restricted mean survival time, that are limited to clinical trial follow-up may underestimate the gains that could accrue over a lifetime.2 If patients are expected to continue treatment indefinitely, estimates of lifetime survival benefit can help inform patient, health system, and payer decision-making.

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