Degtyarev, Evgeny, Bolanos, Natacha, Brody, Joshua, Buchbinder, Aby, Buyse, Marc, Fuchs, Miriam, Halabi, Susan, Hemmings, Robert, Masood, Aisha, Newsome, Simon, Saxton, Claire, Warwick, Lorna, Yateman, Nigel and Zuber, Emmanuel (2024) End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue? Future oncology (London, England). pp. 1-15. ISSN 1744-8301

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.

Item Type:	Article
Date Deposited:	06 Aug 2024 00:46
Last Modified:	06 Aug 2024 00:46
URI:	https://oak.novartis.com/id/eprint/51924