Death: The Simple Clinical Trial Endpoint.

Journal Article (Journal Article)

Death, as a biological phenomenon, is well understood and a commonly employed endpoint for clinical trials. However, death identification and adjudication may be difficult for pragmatic clinical trials (PCT) that rely upon electronic health record and patient reported data. We propose a novel death identification and verification approach that is being used in the ToRsemide compArisoN with furoSemide FOR Management of Heart Failure (TRANSFORM-HF) PCT. We describe our hybrid approach that includes gathering information from clinical trial sites, a centralized call center, and National Death Index searches. Our methods detail how a possible death is triggered from each of these components and the types of information we require to verify a triggered death. Our different trigger/verification elements collectively define the TRANSFORM-HF PCT's definition of a death event.

Full Text

Duke Authors

Cited Authors

  • Eisenstein, EL; Prather, K; Greene, SJ; Harding, T; Harrington, A; Gabriel, D; Jones, I; Mentz, RJ; Velazquez, EJ; Anstrom, KJ

Published Date

  • 2019

Published In

Volume / Issue

  • 257 /

Start / End Page

  • 86 - 91

PubMed ID

  • 30741178

Pubmed Central ID

  • PMC8228236

Electronic International Standard Serial Number (EISSN)

  • 1879-8365


  • eng

Conference Location

  • Netherlands