[Skip to Navigation]
Views 661
Citations 0
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.

Limit 200 characters
Limit 25 characters
Conflicts of Interest Disclosure

Identify all potential conflicts of interest that might be relevant to your comment.

Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.

Err on the side of full disclosure.

If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.

Not all submitted comments are published. Please see our commenting policy for details.

Limit 140 characters
Limit 3600 characters or approximately 600 words