SMART Clinical Trial Design to Develop Effective Dynamic Treatment Regimens

Dr. KELLEY Kidwell, UniverSIty of Michigan

Dates

July 15, 2019; 9-5. The workshop is split 9-12:30, 130-5 such that one can attend either or both sessions

Pricing

Trainees:  $150 for half day and $250 full day

Professional: $200 for half and $350 for full day

 

Description

Diseases or disorders such as substance abuse, depression, obesity, ADHD, autism, HIV, diabetes, and cancer require sequences of treatments over time to address changing characteristics of the disease and the patient. Dynamic Treatment Regimens (DTRs) or adaptive interventions provide guidelines to address the changing needs of disease and the patient. Specifically, DTRs are 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. Effective DTRs can be developed and studied in clinical trials called sequential multiple assignment randomized trials (SMARTs). A SMART is a multi-stage trial design that allows for individuals to be randomized at two or more stages based on intermediate outcomes in order to inform the construction of DTRs. The development of DTRs from SMARTs is useful for building an evidence base for personalized intervention sequences. This workshop is split into 2 parts. In the morning, we will provide an introduction to Dynamic Treatment Regimens and describe how SMART designs can be used to develop high-quality Dynamic Treatment Regimens. In the afternoon, we'll focus on sizing and analyzing a SMART design.

A variety of case studies will be presented to illustrate SMART design throughout the day and analytic methods will be illustrated in R.

Condensed outline of the course:

  • Dynamic treatment regimens

  • Sequential multiple assignment randomized trial (SMART) designs

  • SMART design principles and sample size

  • SMART analysis