The value of a two-armed Bayesian response adaptive randomization trial. Issue 1 (2nd January 2023)

• Record Type: Journal Article
• Authors: Gajewski, Byron J; Carlson, Susan E; Brown, Alexandra R; Mudaranthakam, Dinesh Pal; Kerling, Elizabeth H; Valentine, Christina J
• Is Part Of: Journal of biopharmaceutical statistics. Volume 33:Issue 1(2023)
• Page Start: 43
• Page End: 52
• Publication Date: 2023-01-02
• Subjects: Group sequential designs -- beta-binomial -- predicting accrual; Pharmacy -- Statistical methods -- Periodicals; Drugs -- Testing -- Statistical methods -- Periodicals; Biometry -- Periodicals; Biopharmaceutics -- Periodicals; Pharmacokinetics -- Periodicals; 615.19
• DOI: 10.1080/10543406.2022.2148161
• Languages: English
• ISSNs: 1054-3406

Abstract

ABSTRACT: We investigate the value of a two-armed Bayesian response adaptive randomization (RAR) design to investigate early preterm birth rates of high versus low dose of docosahexaenoic acid during pregnancy. Unexpectedly, the COVID-19 pandemic forced recruitment to pause at 1100 participants rather than the planned 1355. The difference in power between number of participants at the pause and planned was 87% and 90% respectively. We decided to stop the study. This paper describes how the RAR was used to execute the study. The value of RAR in two-armed studies is quite high and their use in the future is promising.