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The sequential multiple assignment randomized trial (SMART) is the gold standard trial design to generate data for the evaluation of multistage treatment regimes. As with conventional (single‐stage) randomized clinical trials, interim monitoring allows early stopping; however, there are few methods for principled interim analysis in SMARTs. Because SMARTs involve multiple stages of treatment, a key...
A treatment regime is a sequence of decision rules, one per decision point, that maps accumulated patient information to a recommended intervention. An optimal treatment regime maximises expected cumulative utility if applied to select interventions in a population of interest. As a treatment regime seeks to improve the quality of healthcare by individualising treatment, it can be viewed as an approach...