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

Publication ,  Journal Article
Degtyarev, E; Bolaños, N; Brody, JD; Buchbinder, A; Buyse, M; Fuchs, M; Halabi, S; Hemmings, R; Masood, A; Newsome, S; Saxton, C; Warwick, L ...
Published in: Future Oncol
2024

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.

Duke Scholars

Published In

Future Oncol

DOI

EISSN

1744-8301

Publication Date

2024

Volume

20

Issue

22

Start / End Page

1601 / 1615

Location

England

Related Subject Headings

  • Treatment Outcome
  • Research Design
  • Randomized Controlled Trials as Topic
  • Oncology & Carcinogenesis
  • Lymphoma, Large B-Cell, Diffuse
  • Humans
  • Endpoint Determination
  • Clinical Trials as Topic
  • Antineoplastic Combined Chemotherapy Protocols
  • 3211 Oncology and carcinogenesis
 

Citation

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Degtyarev, E., Bolaños, N., Brody, J. D., Buchbinder, A., Buyse, M., Fuchs, M., … Zuber, E. (2024). End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue? Future Oncol, 20(22), 1601–1615. https://doi.org/10.1080/14796694.2024.2357537
Degtyarev, Evgeny, Natacha Bolaños, Joshua D. Brody, Aby Buchbinder, Marc Buyse, Miriam Fuchs, Susan Halabi, et al. “End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue?Future Oncol 20, no. 22 (2024): 1601–15. https://doi.org/10.1080/14796694.2024.2357537.
Degtyarev E, Bolaños N, Brody JD, Buchbinder A, Buyse M, Fuchs M, et al. End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue? Future Oncol. 2024;20(22):1601–15.
Degtyarev, Evgeny, et al. “End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue?Future Oncol, vol. 20, no. 22, 2024, pp. 1601–15. Pubmed, doi:10.1080/14796694.2024.2357537.
Degtyarev E, Bolaños N, Brody JD, Buchbinder A, Buyse M, Fuchs M, Halabi S, Hemmings R, Masood A, Newsome S, Saxton C, Warwick L, Yateman NA, Zuber E. End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue? Future Oncol. 2024;20(22):1601–1615.
Journal cover image

Published In

Future Oncol

DOI

EISSN

1744-8301

Publication Date

2024

Volume

20

Issue

22

Start / End Page

1601 / 1615

Location

England

Related Subject Headings

  • Treatment Outcome
  • Research Design
  • Randomized Controlled Trials as Topic
  • Oncology & Carcinogenesis
  • Lymphoma, Large B-Cell, Diffuse
  • Humans
  • Endpoint Determination
  • Clinical Trials as Topic
  • Antineoplastic Combined Chemotherapy Protocols
  • 3211 Oncology and carcinogenesis