Tutorial: Getting SMART about Dynamic Treatment Regimes: A Conceptual Introduction

TitleTutorial: Getting SMART about Dynamic Treatment Regimes: A Conceptual Introduction
Publication TypePresentation
Year of Publication2014
AuthorsAlmirall, D
KeywordsSymposium III

The effective treatment and management of a wide variety of health disorders often requires individualized, sequential decision-making. To do this, each patient’s treatment is dynamically adapted over time based on the patient’s history and changing disease state.

Dynamic treatment regimes (also known as adaptive interventions) operationalize individualized decision making using a sequence of decision rules that specify whether, how, for whom, or when to alter the dose, type, or delivery of pharmacological, behavioral, and/or psychosocial treatments. Recently, there has been a surge of clinical and methodological interest in developing and evaluating dynamic treatment regimes via clinical trials. Specifically, there is great interest in the use of sequential multiple assignment randomized trials (SMART), a type of multi-stage randomized trial design, to build dynamic treatment regimes. The aims of this tutorial are
(1) to provide a brief, conceptual introduction on dynamic treatment regimens and SMART designs, and
(2) to encourage a discussion of how SMARTs can be used to develop high-quality dynamic treatment regimes.


1. Dynamic Treatment Regimes (also known as Adaptive Interventions)
a. What is a dynamic treatment regime?
b. Why do we need dynamic treatment regimes?
c. Connection to individualized, sequential, treatment decision-making
2. Sequential Multiple Assignment Randomized Trials (SMART)
a. What is a SMART study?
b. What is the rationale for proposing a SMART study?
c. What are the dynamic treatment regimes embedded in a SMART?
3. SMART Design Principles
a. Embedded tailoring variables and restricted randomizations
b. What are some typical primary and secondary aims in a SMART?
c. Some sample size considerations
4. SMART Case Studies
a. Autism
b. Alcoholism
5. Open Discussion and Q&A (30 minutes)