The Medical University of Vienna (MUW) is the largest medical research institution in Austria. It was founded in 1365 as a Medical Faculty of the University of Vienna and became an autonomous university in 2004. The MUW consists of 31 clinical departments and 12 medical-theoretical departments. The MUW is experienced with the framework of FP7-projects participating in more than 85 FP7 projects. The university offers an excellent research and administrative infrastucture (IT, controlling, HR-support, access to journals, etc) to conduct such research projects.
The Section of Medical Statistics (IMS) of the Center for Medical Statistics, Informatics, and Intelligent Systems (CeMSIIS) of the Medical University of Vienna, Austria has a long tradition in Medical Statistics with an outstanding track record both in innovative statistical methodological and medical research. The Section has a strong research tradition in cooperative research projects designing and analysing clinical trials. It is a leading research center in statistical methodology for innovative clinical trial design focusing on the development of adaptive design methodology for confirmatory clinical trials and the development of multiple testing procedures for the analysis of clinical trials with multiple objectives. Besides the methodological work, the department is involved in numerous scientific collaborations with clinical colleagues at the MUW and supports more than 200 projects each year. Furthermore, the Section of Medical Statistics is responsible for the statistics education in the curricula for human and dental medicine at the University. Currently the department hosts 15 statisticians of which 9 hold a PhD. Weekly internal seminars as well as regular talks co-organised with the Viennese Section of the Austrian-Swiss Region of the International Biometric Society support collaborations with internal and external scientists. The CEMSIIS hosts also the Section of Clinical Biostatistics which has an extensive expertise in Survival Analysis and Exact Tests.
Main Project Tasks and Experiences related to the project: Main methodological research areas of the section Medical Statistics are sequential designs, adaptive designs, multiple testing, designs for genetic studies. Within the project the section is fully responsible for WP4 “Adaptive design studies in small population groups”.
Ass. Prof. Dr. Franz König is head of the working group “Adaptive Designs and Genetics” at the Section of Medical Statistics at the MUW. From 2008 till 2010 he was seconded to the European Medicines Agency (London, UK), where he was in charge of the then newly founded Biostatistics Working Party (BSWP). He has been involved in the development of guidelines and assessment of statistical methods and clinical trial protocols. He still contributes to several EMA activities listed European expert. He is the statistical member in two ethics committees. His main research interests are multiple testing, adaptive/flexible designs, interim analyses and data safety monitoring boards (DSMB). He has served as Guest Editor for Special Issues in Biometrical Journal and Statistics in Medicine. Furthermore, he has been co- investigator in several peer-reviewed research projects by the Austrian Science Fund to fund several reseachers.
Dr. Peter Bauer, the former head of the CeMSIIS, is Emeritus Professor at the MUW since 2010. Peter Bauer is one of the founding fathers of the theory of adaptive designs in clinical trials. He is currently the statistical expert of the Paediatric Committee (PDCO) and observer of the Biostatistics Working Party (BSWP) of the EMA. In both positions he is continuously involved in reviewing, writing and revising statistical and methodological regulatory guidance documents relevant to small population groups.