SESSION K

TITLE: Statistical Designs and Strategies for Oncology Drug Development
SPEAKERS: Cong Chen, Merck & Co. Inc
MODERATOR: Kalyan Ghosh


Abstract:

Following the tremendous success of immune checkpoint inhibitors and other innovative drugs, last few years have witnessed an explosive growth in number of oncology trials. While the expectation is high for the new drugs or vaccines under development, it is unrealistic to expect all of them to have the same success, especially given the improved standard-of-care. It is imperative to apply cost-effective statistical designs and strategies to oncology drug development.

In this short course, I will introduce basket designs for Phase 1B efficacy screening from both statistical and strategic perspectives. I will then talk about how to effectively transition an early oncology program to late-stage development with focus on the 2-in-1 design and its extensions. This will be followed with a discussion of two common issues in design of Phase 3 confirmatory trials :1) how to account for the possible predictive biomarker effect? 2) how to design and monitor trials for combination therapies, leveraging the independent drug action assumption?

 

Instructor’s Bio:

Dr. Cong Chen is Executive Director of Early Oncology Development Statistics at Merck & Co., Inc. He joined Merck in 1999 after graduating from Iowa State University with a Ph.D. in Statistics. He also holds a MS degree in Mathematics from Indiana University at Bloomington and a BS degree in Probability and Statistics from Peking University, PR China.

As head of the group, he oversees the statistical support of oncology early clinical development and translational biomarker research at Merck. Prior to taking the role in March 2016, he led the statistical support for the development of pembrolizumab (KEYTRUDA), a paradigm changing anti-PD-1 immunotherapy, and played a pivotal role in accelerating its regulatory approvals.

He is a Fellow of American Statistical Association, an Associate Editor of Statistics in Biopharmaceutical Research, a member of Cancer Clinical Research Editorial Board and a co-leader of the DIA Small Population Work Stream. He has published over 75 papers and 10 book chapters on design and analysis of clinical trials, has given multiple short courses on design and analyses of clinical trials and was twice invited to give an oral presentation at the AACR Annual Meeting in recent years on design strategies for oncology drug development.

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