projectdidact.net - Sequential, multiple assignment randomized trial (SMART) designs (Kidwell)

Kelley Kidwell | ProjectDidact

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Kelley Kidwell | ProjectDidact Skip to main content ProjectDidact Toggle navigation Home People Investigators Advisory Board Events News Blog Kelley Kidwell Project Overview: Sequential, multiple work randomized trial (SMART) designs Diseases or disorders such as substance abuse, depression, ADHD, autism, HIV/AIDs, diabetes and cancer require sequences of treatments over time to write waffly characteristics of the disease and the patient. These individualized sequences of treatments are known as dynamic treatment regimens (DTRs; moreover known as adaptive interventions, adaptive treatment policies, stepped care) and are relevant to not only treat, but moreover to prevent diseases or disorders or implement weightier practices. DTRs provide guidelines tailored to the individual to elicit overall optimal outcomes. One way to build and compare dynamic treatment regimens is by using a clinical trial tabbed a sequential multiple work randomized trial (SMART). A SMART is a multi-stage clinical trial where each stage corresponds to a hair-trigger visualization point. The same participants are followed throughout the trial as they follow a specific DTR. Randomization to a set of treatment options at each stage may be based on the participant’s response to previous treatment or other characteristics and behaviors. SMARTs are worldly-wise to write questions well-nigh the weightier treatment at unrepealable points in time, the weightier sequences of treatments (or weightier modes of treatment delivery) depending on intermediate outcomes, the weightier intermediate outcomes to uncontrived treatment, and how to individualize sequences of treatments based on biological, diagnostic and/or other patient information. SMART designs have been unromantic most often in mental health and cancer, but may be unromantic in any area. While SMART designs and the resulting constructive DTRs uncurl with the goals of precision medicine and increasingly closely mimic clinical practice than standard clinical trials in many settings, many researchers and statisticians are unaware of these designs or intimidated by their seeming complexity. We will disseminate information well-nigh what a SMART is, their advantages over other worldwide trial designs, how a SMART can be designed, and how to unriddle data from a SMART. We will develop and disseminate a sample size applet to size a two-stage SMART trial based upon a variety of trial objectives and variegated types of endpoints (i.e., binary, continuous, or survival). We will moreover provide cases studies and associated SAS and R lawmaking for analyzing data resulting from SMART designs.