Online Program Home
My Program

Abstract Details

Activity Number: 554
Type: Topic Contributed
Date/Time: Wednesday, August 3, 2016 : 10:30 AM to 12:20 PM
Sponsor: Scientific and Public Affairs Advisory Committee
Abstract #321139
Title: Finding Optimal Combination in Cancer Drug Development: An Evidence Synthesis Approach
Author(s): Sofia Paul* and Fei Ma and Satrajit Roychoudhury
Companies: Novartis and Novartis and Novartis
Keywords: optimal dose ; combination drug ; meta-analysis ; benefit-risk
Abstract:

In the current era of Oncology drug development, combining multiple drugs is a primary approach for improving anticancer effects. But there are several challenges in the combination drug development. Phase I trials are mainly designed for establishing the MTD and recommended phase II doses (R2PD) of an anticancer agent. In a typical Oncology development program phase I trials with multiple drug combinations are conducted in parallel to find "optimal" combinations and dose(s) for further development in terms of benefit-risk. But this can be challenging due to small trial size and heterogeneity between trials. We propose a model based meta-analytic approach in benefit-risk framework to synthesize all available data to find "optimal" combination regimen(s) or dose(s) for future development. Developing model for combination regimen needs some additional consideration than single agent as monotonicity in dose toxicity and dose efficacy relationships may not always hold. The proposed approach borrows information across different combination for precise estimation and therefore leads robust decision making. We will use a real life example to illustrate the methodology


Authors who are presenting talks have a * after their name.

Back to the full JSM 2016 program

 
 
Copyright © American Statistical Association