Drug Evaluation Committee Introduction of Sequential Multiple Assignment Randomized Trials (SMART)
Data Science Subcommittee
November 2022
Sequential Multiple Assignment Randomized Trials (SMART) is a design for a series of dynamic treatment planning through sequential multiple random assignment. Although SMARTs are currently attracting attention overseas, there is no text book on SMARTs in Japanese.
Therefore, we, the SMART Sub-Team of Task Force 4, Causal Inference, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, introduced SMART with actual examples for clinical staff and explained the design and estimation methods for statistical experts in this deliverable. Sample data and SAS code were also included so that users can get a feel for the actual analysis.
We hope that this publication will help you understand SMART and assist you in planning, analyzing, and interpreting the results of trials that are interested in dynamic treatment planning.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
DS Subcommittee 2021 Task Force 4