Abstract:
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A Sequential Multiple Assignment Randomized Trial (SMART) is a novel clinical trial that has become popular constructing and investigating dynamic treatment regimens, particularly in mental health. This design, however, is extremely applicable to many oncology settings where physicians observe and prescribe treatment based on clinical and patient characteristics in an iterative manner to elicit a desired response (either longer survival or less side effects or some combination of the two). In a SMART, the same patients are followed and receive tailored sequences of treatments, more closely mimicking the actual treatment process. We present examples of oncology SMARTs in practice highlighting the benefits of investigating treatment regimens and discuss possibilities to overcome the challenges, including infrastructure, design, analysis, and regulatory issues, of such a trial in oncology.
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