A phase II / III biomarker-based Bayesian design
Berangere Bastien, Transgene Tomasz Burzykowski, IDDI *Marc Buyse, IDDI Keywords: phase II / III, Bayesian design, biomarker validation Suppose early trials suggest both efficacy of a new drug and the presence of a predictive biomarker. In such a situation, it may make sense to conduct a randomized phase II / III trial to confirm both findings. The phase II portion of the phase II / III trial uses a Bayesian design to confirm efficacy of the drug in the biomarker(+) stratum, and lack of efficacy (or potential harm) in the biomarker(-) stratum. Depending on the posterior probabilities of treatment effects considered clinically worthwhile and futile, either stratum can be continued or discontinued, leading to stopping further development, continuing the phase III trial with enrichment in biomarker(+) patients, or continuing the phase III trial in all patients. The advantages and limitations of this design are explored.
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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