Regulation of Patient Centered Clinical Trials (REPACT)
REPACT is a three-year research collaboration between CeBIL and the Danish Medicines Agency’s Data Analytics Center (DAC). The project team will develop data driven methods to identify neglected populations in clinical trials, analyze possible ways to address neglect, map the regulatory landscape pertaining to the solutions and make policy suggestions for their implementation.
Under-represented populations in clinical trials are one of the issues on the European Medicines Agency’s agenda in their strategy for regulatory science towards 2025. “Neglected populations” are exemplified as elderly, children, pregnant women and ethnic minorities. There may be many good reasons for excluding some populations from clinical trials, e.g. ethical and scientific. But how do we determine when there is a “neglect”? what can be done to address a neglect? And are the regulatory framework of rights, obligations and governance in place to support the solutions?
REPACT will make use of the rich and high-quality health data environment in Denmark, where the Danish CPR system (social security number) makes it possible to couple many different data sets, e.g. on diagnosis and treatments in the healthcare system and medicine sales. This will be combined with information on clinical trials available from the European Medicines Agency. The data driven approach of REPACT will pave the way for an empirical analysis and assessment of the regulatory framework. It will also generate highly relevant input and capacity building for regulatory authorities in relation to issues such as use of real world evidence (RWE) and precision medicine. The team behind resembles the interdisciplinary nature of the project, comprising state of the art scholars, practitioners and experienced regulators in the field of medicine, data science, pharmacy and law.
As first a pilot study comparing populations in clinical trial protokols and reports with data on the actual use of the medicinal products and the demography of the disease in the general population will be conducted. The starting point will be Denmark, hoping that this pilot study will pave the way for the development of methods that can be applied to other conditions and throughout EU.
From September 2021 to august 2022, researchers from CeBIL, Faculty of Humanities and Faculty of Social Sciences and the Danish Medicines Agency will conduct a series of workshops and conferences on the topic neglected populations. The purpose is to create an interdisciplinary forum for the development of initiatives and policies on a national and EU level addressing the underrepresentation of some populations in clinical trials. This will touch upon issues such as scientific, ethical and socio-economic aspects of neglect and multi-level governance in the health- and life science area.
The project has received a seed-funding from Copenhagen Center for Public Policy (CCPP).
Participating researchers are:
- Karsten Vrangbæk (Professor, SAMF)
- Nana Cecilie Halmsted Kongsholm (Post doc, HUM)
- Timo Minssen (Professor, JUR)
- Jakob Wested (Industrial Postdoc, JUR/DKMA)
- Stine Hasling Mogensen (Scientific officer, DKMA)
|Minssen, Timo||Head of Centre, Professor|
- Jakob Wested, DKMA
- Stine Hasling Mogensen, DKMA
- Elisabeth Penninga, DKMA
- Andreas Høiberg Bentsen, DKMA
Regulation of Patient Centered Clinical Trials (REPACT) has received a three year funding from Innovation Fund Denmark.
Project: Regulation of Patient Centered Clinical Trials (REPACT)
(Grant number: 0197-00008B)
Period: 2021 - 2024
DK-2300 Copenhagen S
Phone: +45 35 33 10 03