Bibliographic Details
| Title: |
Implementation of statistical features of a Bayesian two-armed responsive adaptive randomization trial with post hoc analysis of time trend drift. |
| Authors: |
Shergina, Elena1 (AUTHOR), Richter, Kimber P.1 (AUTHOR), Zhang, Chuanwu1,2 (AUTHOR), Mussulman, Laura1 (AUTHOR), Nazir, Niaman1 (AUTHOR), Gajewski, Byron J.1 (AUTHOR) bgajewski@kumc.edu |
| Source: |
Journal of Biopharmaceutical Statistics. Jun2024, p1-15. 15p. 7 Illustrations, 3 Charts. |
| Abstract: |
Bayesian adaptive designs with response adaptive randomization (RAR) have the potential to benefit more participants in a clinical trial. While there are many papers that describe RAR designs and results, there is a scarcity of works reporting the details of RAR implementation from a statistical point exclusively. In this paper, we introduce the statistical methodology and implementation of the trial Changing the Default (CTD). CTD is a single-center prospective RAR comparative effectiveness trial to compare opt-in to opt-out tobacco treatment approaches for hospitalized patients. The design assumed an uninformative prior, conservative initial allocation ratio, and a higher threshold for stopping for success to protect results from statistical bias. A particular emerging concern of RAR designs is the possibility that time trends will occur during the implementation of a trial. If there is a time trend and the analytic plan does not prespecify an appropriate model, this could lead to a biased trial. Adjustment for time trend was not pre-specified in CTD, but post hoc time-adjusted analysis showed no presence of influential drift. This trial was an example of a successful two-armed confirmatory trial with a Bayesian adaptive design using response adaptive randomization. [ABSTRACT FROM AUTHOR] |
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| Database: |
Business Source Complete |
