Intuitive Training on Clinical Trials for Health Technology Assessments (HTA)
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This is a customized continuing education course on the requirements for clinical trials of medical devices for benefit assessment, as conducted in the context of Health Technology Assessments (HTA).
This course is divided into web-based lessons and a classroom training.
The schedules for the classroom training:
Curriculum
- 2 Sections
- 6 Lessons
- 6 Weeks
- Classroom trainingThe classroom training will take place in Frankfurt am Main, Germany, from 5/15/2023 to 5/17/2023. First, we will address the preparation of the study protocol. In particular, we will discuss the search, review and evaluation of the existing evidence. Then we will work together on the main chapters of the study protocol. On the last day, we will discuss the report and publication of the study results and how they can be further used as evidence. We will conclude with a practical exercise on evidence assessment. There will be time for your questions both before and after the training.0
- Web-based lecturesThe web-based lessons offered here provide basic information ranging from a fundamental understanding of the methodology of evidence-based medicine, to the institutions involved, to the processes of approval and benefit assessment for reimbursement of treatments. In addition, two of the presentations address the hot topics of RCTs versus real-world evidence and registries.6
- 1.1Evidence-based medicine – Introduction
- 1.2Responsible institutions from market access to reimbursement in Europe and the USA – Practical application of evidence-based medicine
- 1.3Evidence levels and study types – What is really useful?
- 1.4Medical device development – The right study at the right time
- 1.5RCTs and Real World Evidence
- 1.6Registries – How can registries effectively support clinical research?
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.
