Methodological aspects were the focus of the programme: framework conditions and methodological procedure in relation to IQWiG's benefit assessment, the meaning of the "2-study rule" in evaluating study results and the methodological foundations for assessing benefit.
Presentations (German):
PD Dr. Stefan Lange
Three years of benefit assessments in IQWiG - taking stock (PDF, 739 kB)
Prof. Dr. Ralf Bender
Introduction to the topic "Replication of study results? (PDF, 139 kB)
Dr. Armin Koch (Federal Institute for Drugs and Medical Devices, BfArM)
Pivotal studies: Why do the regulatory authorities usually require that study results be replicated? (PDF, 143 kB)
Friedhelm Leverkus (Pfizer)
Decision approaches and statistical foundations for the cost-benefit assessment in comparison with confirmatory approval studies (PDF, 2 MB)
