The aim of the project is the development of novel methodology for the design and analysis of clinical trials in small populations.
The focus is on four specific areas:
- early phase dose-finding studies in small populations,
- decision-theoretic methods for clinical trials in small populations,
- confirmatory trials in small populations and personalised medicines,
- use of evidence synthesis in the planning and interpretation of clinical trials in small populations and rare diseases.
In the rare disease setting, Bayesian and decision-theoretic methods formally enable to account on the one hand for the potential gain in information as well as the cost (both in economic and opportunity terms) of clinical experimentation, and assess how information from outside the trial can formally be incorporated in the design and decision-making processes.
The project team in Vienna focuses on study designs for the development of personalised medicines and develops methods to evaluate the efficacy of a therapy in a number of sub-populations simultaneously in a confirmatory clinical trial. Also in this context Bayesian and decision theoretic methods as well as adaptive study designs play an important role.
MedUni Vienna Researchers
The Medical University of Vienna is project partner under the leadership of Univ.-Prof. Mag. Dr. Martin Posch.
Ass.-Prof.MMag. Dr. Alexandra Graf (assistant professor)
Thomas Ondra, MSc (PhD Student)
Project coordinator: Prof. Nigel Stallard, Warwick Medical School, University of War
8 project partners
|Topic||7th Framework Health Programme /|
"HEALTH.2013.4.2-3: New methodologies for
clinical trials for small population groups” /
Small or medium-scale focused research project
|Project duration||01.02.2014 - 31.05.2017|
|Funding volume, Medical University of Vienna||423.809 €|
|Funding volume, total||2.268.504 €|