[Forum SIS] COURSE on Adaptive designs and analysis methods: rationales and approaches in clinical developments, S.J. Wang, 2-6 September 2012, Ponte di Legno (BS)

[Stefania Galimberti]

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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>
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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