Work

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

Year: 2022

Type: article

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.

Source: Journal of Biopharmaceutical Statistics

DOI: 10.1080/10543406.2022.2148161

Authors: Byron J Gajewski, Susan E Carlson, Alexandra R Brown, Dinesh Pal Mudaranthakam, Elizabeth H Kerling, Christina J Valentine

Institutions: University of Kansas Medical Center, University of Arizona

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: green

Funders: National Institutes of Health, National Institute of Neurological Disorders and Stroke, Eunice Kennedy Shriver National Institute of Child Health and Human Development