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Activity Number: 171 - SPAAC Poster Competition
Type: Topic Contributed
Date/Time: Tuesday, August 4, 2020 : 10:00 AM to 2:00 PM
Sponsor: Biopharmaceutical Section
Abstract #313667
Title: Interim Monitoring in Sequential Multiple Assignment Randomized Trials
Author(s): Liwen Wu* and Junyao Wang and Abdus S Wahed
Companies: University of Pittsburgh and University of Pittsburgh and University of Pittsburgh
Keywords: Adaptive treatment strategies; Sequential multiple assignment randomized trial; Group sequential methods

Sequential multiple assignment randomized trial (SMART) facilitates simultaneous comparison of multiple adaptive treatment strategies (ATSs), where patients are sequentially randomized to treatments given the response to their own treatment history. Previous studies have established a framework to test the homogeneity of multiple ATSs by a global Wald test on the inverse probability weight-normalized estimators. SMART trials are generally lengthier than classical clinical trials due to the sequential nature of treatment randomization in multiple stages. Thus, it would be beneficial to add interim analyses allowing for early stop if overwhelming efficacy is observed. We extend the traditional group sequential methods to SMARTs and propose a method to perform interim analysis based on an approximation of bi-variate chi-square distribution. Simulation studies demonstrate that the proposed method maintains desired type I error and power with reduced expected sample size. Lastly, we apply our method to real data from a SMART trial assessing the effects of cognitive behavioral therapy and physical therapy in patients with knee osteoarthritis and comorbid subsyndromal depressive symptoms.

Authors who are presenting talks have a * after their name.

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