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

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

Disclosure statement

No potential conflict of interest was reported by the author(s).

Ethics approval and informed consent detail

The ADORE study is approved by the Institutional Review Board (IRB) at The University of Kansas Medical Center under the #STUDY00003455. Subjects (participants) were either able to read or orally understand the study in English or Spanish and signed an informed consent form. The consent form was in both English and Spanish and translators were available to obtain informed consent for potential subjects who were not fluent in English.

Additional information

Funding

Research reported in this publication was supported by the National Institutes of Health Grant [R01HD083292].