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.