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Title: | End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue? | Authors: | Degtyarev, Evgeny Bolanos, Natacha Brody, Joshua D. Buchbinder, Aby BUYSE, Marc Fuchs, Miriam Halabi, Susan Hemmings, Robert Masood, Aisha Newsome, Simon Saxton, Claire Warwick, Lorna Yateman, Nigel A. Zuber, Emmanuel |
Issue Date: | 2024 | Publisher: | TAYLOR & FRANCIS LTD | Source: | Future oncology (London. Print), | Status: | Early view | 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. | Notes: | Degtyarev, E (corresponding author), Novartis Pharm, Basel, Switzerland. evgeny.degtyarev@novartis.com |
Keywords: | estimand framework;event-free survival;non-Hodgkin lymphoma;overall survival;patient-reported outcomes;patient journeys;progression-free survival;treatment effects | Document URI: | http://hdl.handle.net/1942/43331 | ISSN: | 1479-6694 | e-ISSN: | 1744-8301 | DOI: | 10.1080/14796694.2024.2357537 | ISI #: | 001250729700001 | Rights: | 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis GroupThis is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License(http://creativecommons.org/licenses/by- nc- nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properlycited and is not altered, transformed, or built upon in any way. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by theauthor(s) or with their consent. | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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End points in clinical trials in diffuse large B-cell lymphoma time for more dialogue .pdf | Early view | 1.84 MB | Adobe PDF | View/Open |
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