Post-Marketing Studies
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Post-Marketing Studies
Frequently, pharmaceutical companies carry out post-marketing studies (PMS) following market approval of medicinal products and devices. These observational studies are intended to provide scientific insight into the long-term safety, application and interaction of drugs in everyday medical practice. Government regulators use PMS to monitor drug safety and especially to detect rare and very rare side effects. This important task of PMS is legally defined and standardized within the European Union. There is little known about the content and methodological aspects of PMS. The project investigates the practice of PMS to assess its scientific value.
Investigations on Post-Marketing Studies at the IPH
Project management:
PD Dr. Christof Prugger
Project partners:
Dr. Angela Spelsberg, TI-D e.V. and Comprehensive Cancer Centre Aachen, Aachen, Germany
Prof. Ulrich Keil, Institute of Epidemiology and Social Medicine, University of Münster, Münster, Germany
Dr. Juan Erviti, Unit of Innovation and Organization, Navarre Health Service, Pamplona, Spain
Prof. Peter Doshi, University of Maryland, School of Pharmacy, Baltimore, Maryland, USA
Publications:
- Prugger C, Spelsberg A, Keil U, Erviti J, Doshi P. Evaluating covid-19 vaccine efficacy and saftey in the post-authorisation phase. BMJ 2021;375:e067570
- Spelsberg A, Prugger C, Doshi P, Ostrowski K, Witte T, Hüsgen D, Keil U. Working Group on Health and Working Group on Freedom of Information, Transparency International Deutschland eV.. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies. BMJ 2017;356:j337
- Spelsberg A, Keil U, Prugger C. Authors‘ reply to Fralick and Kesselheim. BMJ 2017;357:j1850