Abstract Number:
1921
Submission Type:
Contributed Abstract
Contributed Abstract Type:
Poster
Participants:
Elena Shergina (1), Kimber Richter (2), Chuanwu Zhang (3), Laura Mussulman (4), Niaman Nazir (2), Byron Gajewski (1)
Institutions:
(1) University of Kansas Medical Center, N/A, (2) University of Kansas Medical Centre, Kansas City, KS, (3) Sanofi, N/A, (4) University of Kansas Medical Centre, Kansas City, United States
Co-Author(s):
First Author:
Presenting Author:
Abstract Text:
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.
Keywords:
drift analysis |comparative effectiveness trial|Bayesian adaptive designs| | |
Sponsors:
Section on Bayesian Statistical Science
Tracks:
Applications in Life Sciences and Medicine
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