Statisticalps Summer Course IV Edition- 2012

Con il patrocinio della SISMEC
on Medical Statistics in the Alps
4th Edition September 2-6, 2012
Residential Course Hotel Mirella – Ponte di Legno, Brescia, Italy
Title of the Course: Adaptive Design and Analysis Methods. Rationales and Approaches in Clinical Development

Instructor Sue-Jane Wang, Ph.D. -Office of Biostatistics - Office of Translational Sciences Center for Drug Evaluation and Research -U.S. Food and Drug Administration Silver Spring, Maryland, USA

Objectives of the Course
An adaptive design clinical trial allows modifications to the planned design and/or analysis approaches for statistical inference of an ongoing trial. The potential advantages of an adaptive design are its flexibility. It is worth to note that clinical drug development essentially consists of a sequence of clinical studies from drug discovery to evidence setting. Statistical methodologies in exploratory adaptive trials are increasing and some are novel aimed for learning purposes. In contrast, statistical inference impacted by adaptation within the trial requires consideration of pre-specified adaptation rules that drive the changes mimicking design elements.

Coordinators: Maria Grazia Valsecchi, Stefania Galimberti
Center of Biostatistics for Clinical Epidemiology
Department of Clinical Medicine and Prevention
University of Milano-Bicocca