The value of a two-armed Bayesian response adaptive randomization trial

J Biopharm Stat. 2023 Jan 2;33(1):43-52. doi: 10.1080/10543406.2022.2148161. Epub 2022 Nov 21.

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.

Keywords: Group sequential designs; beta-binomial; predicting accrual.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Bayes Theorem
  • COVID-19* / epidemiology
  • Female
  • Humans
  • Infant, Newborn
  • Pandemics
  • Premature Birth*
  • Random Allocation
  • Research Design