Future oncology (London, England) · 2024
End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue?
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Degtyarev Evgeny, Bolaños 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
Аннотация
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.