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STATISTICALPS: course on medical statistics...in the Alps
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ADAPTIVE DESIGNS AND ANALYSIS METHODS:
RATIONALES AND APPROACHES IN CLINICAL DEVELOPMENTS
2-6 September 2012 - Residential course
Ponte di Legno, Brescia, Italy
FACULTY:
SUE-JANE WANG
Office of Biostatistics, Office of Translational Sciences
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, Maryland, USA
COORDINATORS:
Maria Grazia Valsecchi
Stefania Galimberti
Center of Biostatistics for Clinical Epidemiology
Department of Clinical Medicine and Prevention
University of Milano-Bicocca
ABSTRACT:
This course is structured into three parts. The first part will give an overview of adaptive design rationales in clinical development and basic theories, to be followed by exploratory adaptive design methods. The second part will introduce rigorous statistical methodologies and the use of such methods for analyzing adequate and well-controlled confirmatory adaptive trials. Overviews on adaptation options that are appropriate for biomarker associated adaptive designs will be given. The third part will present design implementation, trial logistics models, and regulatory guidance on adaptive designs for drugs and biologics development. Both Bayesian and frequentist methods will be illustrated using typical case examples and sources that are currently available in early and late phase development.
For full details on the course go to:
http://www.statmed.medicina.unimib.it/statisticalps2012/statisticalps.htm
IMPORTANT:
Up to two scholarships will be provided for participation of PhD students. Modalities for application are explained in the web page.
*** DEADLINE FOR REGISTRATION IS MAY 1, 2012 ***
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