|
Activity Number:
|
385
- Biomarkers, Endpoint Validation and Other Topics
|
|
Type:
|
Contributed
|
|
Date/Time:
|
Thursday, August 12, 2021 : 12:00 PM to 1:50 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
|
Abstract #319053
|
|
|
Title:
|
Optimal Dose Finding Using Bayesian Utility with Toxicity and Efficacy Endpoints
|
|
Author(s):
|
Haolun Shi* and Ruitao Lin and Ying Yuan and Jiguo Cao
|
|
Companies:
|
Simon Fraser University and The University of Texas MD Anderson Cancer Center and Department of Biostatistics, University of Texas MD Anderson Cancer Center and Simon Fraser University
|
|
Keywords:
|
Clinical Trial Design;
Bayesian Utility;
Dose finding;
Phase I Trial;
Toxicity;
Efficacy
|
|
Abstract:
|
Molecularly targeted agents and immunotherapy have revolutionized modern cancer treatment. Unlike chemotherapy, the maximum tolerated dose of the targeted therapies may not pose significant clinical benefit over the lower doses. By simultaneously considering both binary toxicity and efficacy endpoints, phase I/II trials can identify a better dose for subsequent phase II trials than traditional phase I trials in terms of efficacy--toxicity tradeoff. Existing phase I/II dose-finding methods are model-based or need to pre-specify many design parameters, which makes them difficult to implement in practice. To strengthen and simplify the current practice of phase I/II trials, we propose a utility-based toxicity probability interval design for finding the optimal biological dose (OBD) where binary toxicity and efficacy endpoints are observed. The design is flexible in accommodating various utility functions while only needs minimum design parameters.
|
Authors who are presenting talks have a * after their name.
