American Statistical Association
New York City
Metropolitan Area Chapter

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



SAMPLE SIZE CONSIDERATIONS FOR PRECISION MEDICINE

by

Dr. Eric Laber
Professor, Statistics Department
North Carolina State University

Host: Min Qian


Abstract

Sequential Multiple Assignment Randomized Trials (SMARTs) are considered the gold standard for estimation and evaluation of treatment regimes. SMARTs are typically sized to ensure sufficient power for a simple comparison, e.g., the comparison of two fixed treatment sequences. Estimation of an optimal treatment regime is conducted as part of a secondary and hypothesis-generating analysis with formal evaluation of the estimated optimal regime deferred to a follow-up trial. However, running a follow-up trial to evaluate an estimated optimal treatment regime is costly and time-consuming; furthermore, the estimated optimal regime that is to be evaluated in such a follow-up trial may be far from optimal if the original trial was underpowered for estimation of an optimal regime. We derive sample size procedures for a SMART that ensure: (i) sufficient power for comparing the optimal treatment regime with standard of care; and (ii) the estimated optimal regime is within a given tolerance of the true optimal regime with high-probability. We establish asymptotic validity of the proposed procedures and demonstrate their finite sample performance in a series of simulation experiments.


Date: Wednesday, September 18, 2019
Time: 4:00 P.M. - 5:00 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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