Stat4Onc
2019 Symposium Short Courses
April 25,
2019
Morning courses 8:30 AM to 12:00
noon with one break
Afternoon
courses 1:30 PM to 5:00
PM
with one break
Course 4 (Afternoon Course) Innovative
Cost-Effective Designs for Oncology Drug Development
Instructor – Dr. Cong Chen, Merck & Co., Inc.
Abstract
Following the tremendous success of PD-1
(or PD-L1) inhibitors, 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 innovative cost-effective designs to the development.
In this short course, after a motivating
case study, I will introduce optimal basket designs for Phase 1B efficacy
screening from various practical perfectives. I will then talk about advanced
utilization of intermediate endpoints for making transitional decisions in an
operationally seamless design with dose-selection and a statistically seamless
2-in-1 design. I will conclude with introduction of new Phase 3 designs for
trials with a biomarker population (e.g., adaptive population expansions and
simultaneous testing of a monotherapy and a combination therapy in a single
trial).
Biography
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 Beijing University, PR
China.
As head of the group, he oversees the
statistical support of oncology early clinical development 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 70 papers and 9 book
chapters on design and analysis of clinical trials, and was twice invited to
give an oral presentation at the AACR Annual Meeting in recent years on
oncology drug development.