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

Byron J Gajewski Susan E CarlsonAlexandra R BrownDinesh Pal MudaranthakamElizabeth H KerlingChristina J Valentine

Published in: Journal of biopharmaceutical statistics (2022)

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.

Keyphrases

preterm birth
low dose
randomized controlled trial
clinical trial
study protocol
high dose
current status
preterm infants
case control
double blind