Considerations for a Practical Use of Brick Tunnel Randomization Procedure

• Activity Number: 635
• Type: Topic Contributed
• Date/Time: Thursday, August 13, 2015 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Yevgen Tymofyeyev*
• Companies: J&J PRD
• Keywords: Brick Tunnel Randomization ; Unequal Allocation ; Allocation Ratio Preserving Randomization ; Restricted Randomization

Abstract

Brick Tunnel Randomization (BTR) was introduced to accommodate random subject allocation in studies with inconvenient allocation ratio (resulting in a large block size) while controlling imbalance more tightly than the permuted block randomization. The Wide Brick Tunnel Randomization (WBTR) expands the procedure to allow an increase in the number of possible allocation sequences which could be useful, for example, in open-label studies with unequal allocation when it is important to reduce assignment predictability. In this presentation we discuss applications of BTR and WBTR in clinical trials; consider ways to generate and evaluate properties of allocation sequences for BTR and WBTR procedures using available SAS and R software.