Intuitive Training on clinical trials with diagnostics aiming to support benefit assessment of European HTA bodies
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Training on the specific requirements of IQWIG and G-BA on diagnostic trials aiming to show additional benefit of a treatment method for reimbursement negotiations to be provided online or as web-based session including an introductory summary of the key points of the design aspects of diagnostic studies as a basis for collaboration / discussion with the various departments involved and a comparison of the requirements of IQWiG / G-BA with those of HAS and NICE
Curriculum
- 1 Section
- 3 Lessons
- 6 Weeks
- Intitive Training on diagnostic trials3
Instructor
My name is Dörthe Seidel. I studied medicine at the Universities of Rostock and RWTH Aachen and am a licensed physician. I worked for 13 years at the University of Witten/Herdecke in the Division of Clinical Research at the Institute for Research in Operative Medicine in Cologne.
From conception to publication, I was Principle Coordinating Investigator of a German-national and an international randomized clinical trial on the effectiveness and safety of a treatment method with an innovative medical device. In addition, I have accompanied many other study projects as Head of Department. Furthermore, I have been working for many years as a consultant in the field of evidence-based medicine for international companies in the medical device industry, preparing evidence analyses, assisting with applications and planning studies. In my practical work in the field of clinical trials, I have learned a lot, made many mistakes and, over time, understood many interrelationships. I would like to share this knowledge.
