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End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue?

  • Evgeny Degtyarev
  • , Natacha Bolaños
  • , Joshua D. Brody
  • , Aby Buchbinder
  • , Marc Buyse
  • , Miriam Fuchs
  • , Susan Halabi
  • , Robert Hemmings
  • , Aisha Masood
  • , Simon Newsome
  • , Claire Saxton
  • , Lorna Warwick
  • , Nigel A. Yateman
  • , Emmanuel Zuber

Research output: Contribution to journalComment/debate

4 Scopus citations

Abstract

We observed lack of clarity and consistency in end point definitions of large randomized clinical trials in diffuse large B-cell lymphoma. These inconsistencies are such that trials might, in fact, address different clinical questions. They complicate interpretation of results, including comparisons across studies. Problems arise from different ways to account for events occurring after randomization including absence of improvement in disease status, treatment discontinuation or the initiation of new therapy. We call for more dialogue between stakeholders to define with clarity the questions of interest and corresponding end points. We illustrate that assessing different end point rules across a range of plausible patient journeys can be a powerful tool to facilitate such a discussion and contribute to better understanding of patient-relevant end points.

Original languageEnglish
Pages (from-to)1601-1615
Number of pages15
JournalFuture Oncology
Volume20
Issue number22
DOIs
StatePublished - 2024

Keywords

  • estimand framework
  • event-free survival
  • non-Hodgkin lymphoma
  • overall survival
  • patient journeys
  • patient-reported outcomes
  • progression-free survival
  • treatment effects

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