Sequential, Multiple Assignment, Randomized Trials (SMART)


A dynamic treatment regimen (DTR) is a prespecified set of decision rules that can be used to guide important clinical decisions about treatment planning. This includes decisions concerning how to begin treatment based on a patient’s characteristics at entry, as well as how to tailor treatment over time based on the patient’s changing needs. Sequential, multiple assignment, randomized trials (SMARTs) are a type of experimental design that can be used to build effective dynamic treatment regimens (DTRs). This chapter provides an introduction to DTRs, common types of scientific questions researchers may have concerning the development of a highly effective DTR, and how SMARTs can be used to address such questions. To illustrate ideas, we discuss the design of a SMART used to answer critical questions in the development of a DTR for individuals diagnosed with alcohol use disorder.

Principles and Practice of Clinical Trials

Principles and Practice of Clinical Trials is a living reference work edited by Steven Piantadosi and Curtis L. Meinert.