Maximally Flexible Bayesian Designs in Randomized Clinical Trials
View Presentation *Frank Harrell, Jr., Vanderbilt University Keywords: This presentation will cover the disadvantages of the traditional frequentist paradigm and will then turn to the development of a Bayesian flexible design for a biologic agent in a Phase II clinical trial. The design allows for infinitely many looks at the data and for possible study extension and conversion to adaptive allocation. Unlike frequentist sample size re-estimation procedures, the Bayesian procedure does not require penalizing the final analysis for having done earlier analyses nor does it require downweighting of data collected before the decision to extend the study. The study is easily extended if results obtained at the originally planned study termination are equivocal. The final analysis uses the same analysis procedure as used at the initial analysis, whereas there is no consensus in the frequentist world for how to analyze an extended study. Our primary analysis is based on a Bayesian Cox proportional hazards model using a skeptical prior distribution.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC