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Recent Advances in Adaptive Clinical Trial Designs for Medical Writers
Program Code:
380
Date:
Wednesday, June 27, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
:
John Whitaker, INC Research
PRESENTER
(S):
John Whitaker, INC Research
A PhD in pharmacology and MSc in statistics provides statistical rigor to clinical research without losing the clinical perspective. Founder of Statistical Revelations, providing biometrical consulting services. Annie makes statistics understandable to the non-statistician.
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Dr. James Hung is currently Director, Division of Biometrics I, CDER, US FDA. The division provides services for the medical divisions: Cardiovascular-Renal, Neurology, Psychiatry.
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Description
In this session, speakers will review the types of adaptations that can be built into clinical trials and the types of concerns these adaptations raise with regulators and the scientific community. Statistical methodologies will also be reviewed.
Learning Objectives:
Describe the current uses and future directions of adaptive trials in drug development
Discuss prior successes and failures in the use of adaptive trial designs
Identify the complex position of regulatory agencies on the use of adaptive trials.