It is a well-known and recognized requirement that in clinical trials, in addition to evaluating (statistical) significance, the (clinical) relevance of results should also be evaluated. This year "IQWiG in dialogue” therefore deals with the approach to such an evaluation within the framework of systematic reviews and its importance to the approval of drugs, as well as to the conduct and assessment of clinical trials.
On 18 June 2010, 155 participants discussed the necessity, methods and consequences of relevance assessments with representatives from IQWiG, regulatory authorities, universities and industry.
Presentations (German):
Prof. Dr. Ralf Bender
Introduction to the topic The evaluation of clinical relevance in benefit assessments (423 kB)
PD (Private Lecturer) Dr. Stefan Lange
A formalized approach to evaluate the relevance of group differences on scales (499 kB)
Dr. Thomas Kaiser
Is the effect relevant? Experiences in the assessment of drugs (603 kB)
Dr. Karl Broich (Federal Institute for Drugs and Medical Devices)
The role of proof of efficacy and clinical relevance within the framework of approval decisions (3 MB)
Prof. Dr. Dieter Hauschke (University Clinic Freiburg)
The importance of clinical relevance to the feasibility of clinical trials - a challenge for clinicians and biometricians (873 kB)
