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STATISTICALPS: course on medical statistics…in the Alps
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We are pleased to announce the fourth edition of STATISTICALPS
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, PhD
Office of Biostatistics, Office of Translational Sciences
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, Maryland, USA
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.
*** DEADLINE FOR REGISTRATION IS MAY 1, 2012 ***
For some details on the course, go to:
http://www.statmed.medicina.unimib.it/statisticalps2012/statisticalps.htm
Please, keep checking our website for any updates, further information will be available soon.
COORDINATORS:
Prof. Maria Grazia Valsecchi
Dott. Stefania Galimberti
Center of Biostatistics for Clinical Epidemiology
Department of Clinical Medicine and Prevention
University of Milano-Bicocca
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