American Statistical Association
New York City
Metropolitan Area Chapter

Levin Lecture Series: Spring 2019 Colloquium Seminars
Department of Biostatistics
Mailman School of Public Health
Columbia University



A MODULAR FRAMEWORK FOR SEAMLESS ONCOLOGY TRIALS

by

Phil Boonstra
Assistant Professor
Department of Biostatistics
University of Michigan

Host: Dr. Ken Cheung


Abstract

With a more sophisticated understanding of the etiology and mechanisms of cancer, and more therapeutic options than ever in this domain, phase I oncology trials today are frequently tasked with multiple primary objectives. More specifically, many such designs are now 'seamless' in nature, meaning that, in addition to estimating a maximum tolerated dose, initial efficacy estimates at this dose level in one or more subpopulation are sought. Trial sponsors are often disinclined to proceed with further study in the absence of this additional efficacy evidence. However, with this growing complexity in trial design, it becomes challenging to analytically calculate even fundamental operating characteristics of these trials, such as (i) what is the probability that the design will identify an acceptable, i.e. safe and efficacious dose level? or (ii) how many patients will be assigned to an acceptable dose level on average? To that end, in this talk, I propose a new modular framework for thinking about and designing seamless oncology trials. Each module is either a dose assignment step or a dose-efficacy evaluation, and multiple such modules can be implemented sequentially. Just as important, I also present a trial simulator to numerically estimate the operating characteristics of such modular trials. Together, this design framework and its accompanying simulator allow the clinical trialist to compare multiple different candidate designs, more rigorously assess performance, better justify sample sizes, and ultimately select a higher quality design.


Date: Thursday, March 7, 2019
Time: 11:45 A.M. - 12:45 P.M.
Location: Mailman School of Public Health
Department of Biostatistics
722 West 168th Street
AR Building
8th Floor Auditorium
New York, New York

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