Death

June 25, 2026: New Podcast Addresses Challenges Associated With Death as an Endpoint

Posted on by Sophia Ramirez

In a new episode of the Rethinking Clinical Trials Podcast, Brad Hammill and Keith Marsolo of the Duke University School of Medicine discussed the use of death as an endpoint, a section in the Living Textbook chapter on Choosing and Specifying Endpoints and Outcomes.

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Death is “the hardest of hard endpoints,” moderator Lesley Curtis observed. It’s objective and unambiguous at the individual level but surprisingly complicated to capture in clinical trials.

“ Unless somebody died while they were at your healthcare facility, you need to learn about that death,” Hammill said. “ But how are you planning to learn about the deaths of your participants in your trial? What methods do you have in place for that?”

The more decentralized or pragmatic a trial is, the more complicated and expensive it can be to keep track of participants.

“In a perfect world you’d have extensive follow-up, participant monitoring and the like, but that’s not really feasible from a budgetary perspective. You have to rely on proxy measures, and all of those come with trade-offs,” said Marsolo.

The discussion covered several methods used to ascertain participant mortality and their associated logistical considerations.

Hammill and Marsolo were both contributors to the Living Textbook chapter. Hammill is an associate professor of population health sciences. Marsolo is an associate professor of population health sciences and chair of the NIH Collaboratory’s Electronic Health Records Core.

March 5, 2019: New Living Textbook Section on Using Death as an Endpoint

Posted on by Karen Staman

Using death as an endpoint in pragmatic clinical trials is challenging because there are no standardized processes for ascertaining patient deaths in the United States. If a patient dies outside of a clinical care system, ascertaining if and how a death has occurred is considerably complicated. There are multiple sources of vital statistics data, each with different amounts of lag time, linking approaches, costs, and specificity of information. For example, some sources include cause of death while others include only fact of death; some have a lag time of a few months and some may take over a year; some charge by the individual file and some have an annual subscription fee.

This section of the Living Textbook describes different death data sources, how to obtain information from them, and the pros and cons of each.

“Death identification and adjudication may be more complicated with pragmatic clinical trials (PCTs) that rely on data collected from the patient’s electronic health record (EHR), medical claims, self-report, or medical devices.” —Eisenstein E, et al. Choosing and Specifying Endpoints and Outcomes: Using Death as an Endpoint. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials.

The sources of data described in this section include the Death Master File, the Medicare Master Beneficiary Summary File, state vital statistics, the Fact of Death File, the National Death Index, and call centers. The section also presents a case study to illustrate a hybrid death identification and verification approach used in the ToRsemide compArisoN with furoSemide FOR Management of Heart Failure (TRANSFORM-HF) PCT (ClinicalTrials.gov Identifier: NCT03296813).