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Interim monitoring in sequential multiple assignment randomized trials

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  • Liwen Wu
  • Junyao Wang
  • Abdus S. Wahed

Abstract

A sequential multiple assignment randomized trial (SMART) facilitates the comparison of multiple adaptive treatment strategies (ATSs) simultaneously. Previous studies have established a framework to test the homogeneity of multiple ATSs by a global Wald test through inverse probability weighting. SMARTs 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 an early stop if overwhelming efficacy is observed. We introduce group sequential methods to SMARTs to facilitate interim monitoring based on the multivariate chi‐square distribution. Simulation studies demonstrate that the proposed interim monitoring in SMART (IM‐SMART) maintains the desired type I error and power with reduced expected sample size compared to the classical SMART. Finally, we illustrate our method by reanalyzing a SMART assessing the effects of cognitive behavioral and physical therapies in patients with knee osteoarthritis and comorbid subsyndromal depressive symptoms.

Suggested Citation

  • Liwen Wu & Junyao Wang & Abdus S. Wahed, 2023. "Interim monitoring in sequential multiple assignment randomized trials," Biometrics, The International Biometric Society, vol. 79(1), pages 368-380, March.
    • Handle: RePEc:bla:biomet:v:79:y:2023:i:1:p:368-380
    DOI: 10.1111/biom.13562
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    References listed on IDEAS

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    1. Gregory, Allan W & Veall, Michael R, 1985. "Formulating Wald Tests of Nonlinear Restrictions," Econometrica, Econometric Society, vol. 53(6), pages 1465-1468, November.
    2. Lisa V. Hampson & Christopher Jennison, 2013. "Group sequential tests for delayed responses (with discussion)," Journal of the Royal Statistical Society Series B, Royal Statistical Society, vol. 75(1), pages 3-54, January.
    3. Kelley M. Kidwell & Nicholas J. Seewald & Qui Tran & Connie Kasari & Daniel Almirall, 2018. "Design and analysis considerations for comparing dynamic treatment regimens with binary outcomes from sequential multiple assignment randomized trials," Journal of Applied Statistics, Taylor & Francis Journals, vol. 45(9), pages 1628-1651, July.
    4. Lafontaine, Francine & White, Kenneth J., 1986. "Obtaining any Wald statistic you want," Economics Letters, Elsevier, vol. 21(1), pages 35-40.
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    1. Xinru WANG & Nina DELIU & NARITA Yusuke & Bibhas CHAKRABORTY, 2023. "SMART-EXAM: Incorporating Participants' Welfare into Sequential Multiple Assignment Randomized Trials," Discussion papers 23081, Research Institute of Economy, Trade and Industry (RIETI).

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