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SMART Clinical Trial Design for Tailored Treatment Guidelines

  • University of Michigan Frankel Cardiovascular Center Danto Auditorium 1500 E Medical Center Drive Ann Arbor, MI 48109 United States (map)

This talk will introduce sequential, multiple assignment, randomized trial (SMART) design as a tool to build effective, tailored intervention guidelines used for the prevention or treatment of diseases or disorders or for the implementation of best practices. 

 Diseases or disorders such as substance abuse, depression, ADHD, autism, HIV/AIDs, diabetes and cancer require sequences of treatments over time to address changing characteristics of the disease and the patient. These tailored treatment guidelines are known as dynamic treatment regimens (DTRs; also known as adaptive interventions) and are relevant to not only treat, but also to prevent diseases or disorders or implement best practices. DTRs provide guidelines tailored to the individual to elicit overall optimal outcomes. One way to build and compare DTRs is by using a clinical trial called a sequential, multiple assignment, randomized trial (SMART). A SMART is a multi-stage clinical trial where each stage corresponds to a critical decision point and some participants may be re-randomized based on intermediate outcomes. The same participants are followed throughout the trial as they follow a specific DTR. In this talk, we will introduce SMART designs and compare them to standard trial designs, provide guidance on the types of questions that they can address, how to size such trials, and briefly introduce how to analyze a SMART to find evidence for effective DTRs.

Register here to reserve your lunch. This event is hosted by MICHR and the Applied Biostatistical Sciences Network.