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Extrapolating Survival From Randomized Clinical Trial Data—Possibilities and Caution
JAMA Cardiology  (IF14.676),  Pub Date : 2021-11-01, DOI: 10.1001/jamacardio.2021.2629
Laine Elliott Thomas, Ann Marie Navar, Michael J. Pencina

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.