Patient and public involvement and engagement in the development of innovative patient-centric early phase dose-finding trial designs

Abstract Background In light of the FDA’s Project Optimus initiative, there is fresh interest in leveraging Patient-reported Outcome (PRO) data to enhance the assessment of tolerability for investigational therapies within early phase dose-finding oncology trials. Typically, dose escalation in most...

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Bibliographic Details
Main Authors: Emily Alger, Mary Van Zyl, Olalekan Lee Aiyegbusi, Dave Chuter, Lizzie Dean, Anna Minchom, Christina Yap
Format: Article
Language:English
Published: BMC 2024-06-01
Series:Research Involvement and Engagement
Subjects:
Online Access:https://doi.org/10.1186/s40900-024-00599-7