End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue?
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
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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
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
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