TL8: Bayesian Method, Adaptive Design and Enhanced Quantitative Decision in Early Drug Development
*Tianhui Zhou, Pfizer Inc Keywords: With the recent development on FDA adaptive design guideline and guideline on bayesian method, it's embraced by FDA and statistical community that innovative designs will have great influence in the learning stage of drug development. In reality, there are still resistences to use adaptive design and bayesian method in early phase I or phase II trials. In this session, we will bring up a few real life examples to share and learn. Questions will be discussed such as what's the most concerns clinical team have; how to influence the team to improve trial design; ways to enhance the decision making in phase I/II trials.
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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