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Real World Data - New Frontiers and Current Use-Cases for it´s Collection in the Context of Clinical Studies
Fewer than half of new drugs have data on their comparative benefits and harms against existing treatment options at the time of regulatory approval in Europe and the USA. Comparative evidence generation is even sparser for medical devices. Use of non-randomised studies for the evaluation of clinical benefit in the post-marketing period should be limited to instances when the magnitude of effect is deemed to be large or when it is possible to reasonably infer the comparative benefits or risks in settings, in which doing a randomised trial is not feasible.

00:50:00

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Speakers

Harald Wagner
Director Clinical Operations, Europe and North America @AMS - Advanced Medical Services
Harald has more than 25 years of experience in the health care industry with a background in pharmaceutical technology. He has a strong focus in department leadership, planning and strategy by managing and directing Clinical Operations for AMS Advanced Medical Services in Europe and North America. Harald also has strong experience in the operational aspects of clinical research, such as: Project management, study planning, execution and vendor management. Harald has varied experience from being on the front lines with sites to working in biotech laboratories. Given his pharmaceutical background, his passion is to help bring therapies to patients faster. His goal at AMS is to help life science companies break down the barriers, and find solutions so that together with the sponsor, we can deliver impactful results to patients and stakeholders.
Kirsten Dahm
Medical Writer and Digital Health Application (DiGA) Expert @AMS - Advanced Medical Services
Kirsten is an experienced Medical Writer and has been with AMS Advanced Medical Services for 6 years. She has worked on projects in hematology, oncology, neurology, internal medicine, immunology (vaccination app), psychiatry and psychology. Kirsten support AMS clients in a variety of Real-World Evidence projects, including Non-interventional Study designs and Clinical Trials with the preparation of study documents such as protocols, observation plans, patient information sheet, patient informed consent, publications, posters, abstracts, and the Clinical Study Report. Since the introduction of the German DiGA Fast Track process in autumn 2020, Kirsten has been supporting international pharmaceutical companies and DiGA developers on the way to getting their app or web application reimbursed by statutory health insurance in Germany. Kirsten has provided assistance regarding development of the evaluation concept and preparation of the study protocol.