The Workshop

Pre-conference workshop An introduction to flexible adaptive designs for clinical trials
Date:	Monday 8 September 2008
Led by:	Dr Werner Brannath Medical University of Vienna and Dr Gernot Wassmer University of Cologne	This workshop will provide an overview of all the current methodologies using practical examples and interactive discussions.
About the workshop:
The workshop will give an introduction to flexible adaptive designs for clinical trials. Adaptive designs allow for mid-course design adaptations that are based on unblinded interim data as well as on all information from in or outside the trial without compromising the overall type I error rate. Design adaptations could include sample size adjustments, dropping of treatment arms, change of the study population and so on. Mid-trial changes are of particular interest for drug development programs to combine different phases (e.g. 2 and 3) into a single trial which may lead to substantial savings in cost and time.
Workshop agenda
12:00		Registration and coffee
12:30	Session 1:	Introduction
12:30	Session 2:	Group sequential designs
13:30	Session 3a:	Adaptive designs: hypothesis testing
14:15		Afternoon refreshments
14:30	Session 3b:	Adaptive designs: estimation
15:00	Session 4:	Software for adaptive designs
15:30		Refreshments
15:45	Session 5:	Multiple testing in adaptive designs
16:30	Session 6:	Case studies
17:00		Close of workshop
About workshop leaders:
	Dr Werner Brannath	Dr Werner Brannath is Associate Professor in Biostatistics at the Medical University of Vienna. He received his PhD in mathematics in 1997 and has been working at the Department of Medical Statistics since August 1998. He has written several papers on multiple testing and adaptive designs. One of his major research focuses is estimation in adaptive designs.
	Dr Gernot Wassmer	Dr Gernot Wassmer is an Associate Professor for Biostatistics at the Institute of Medical Statistics, University of Cologne. He received his PhD in 1993 at the University of Munich. He was a Research Fellow at the Institute of Statistics, University of Munich and the Institute for Epidemiology, GSF Neuherberg. He also works as a statistical consultant for the pharmaceutical industry and he is a co-founder of the ADDPLAN Software Corporation. His major research interest is in the field of statistical procedures for group sequential and adaptive plans in clinical trials.