Curso: "Adaptive Designs and Analysis Methods: Rationales and Approaches in Clinical Developments"
Faculty: SUE-JANE WANG, U.S. Food and Drug Administration. Office of Biostatistics, Office of Translational Sciences Center for Drug Evaluation and Research
Coordinators: Maria Grazia Valsecchi & Stefania Galimberti. Center of Biostatistics for Clinical Epidemiology, University of Milano-Bicocca
Abstract: This course is structured into three parts. The first part will give and 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 full details on the course go to the course website.