Representative clinical trials - Developing Policies for Neglected Populations (DePNeP)
DePNeP will develop policy recommendations on how to increase inclusiveness in clinical trials in EU. This will involve ethical, social and legal aspects as well as scientific and technological.
The same medicine may have different effects in different people. Therefore, medicine should be tested in populations representative of the users. This raise ethical, scientific and practical challenges for regulatory authorities, industry and patients e.g. on real world data and trial design.
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?
The Danish Medicine Agency’s Data Analytics Center (DAC) is a partner in DePNeP. DAC works towards making it possible for the Danish Medicines Agency to provide new forms of advice to the pharma industry to enable the development of new medicine including medicine for rare diseases and neglected populations.
Read more about DAC here (in Danish)
Researchers
| Navn | Titel | Telefon | |
|---|---|---|---|
| Søg i Navn | Søg i Titel | Søg i Telefon | |
| Minssen, Timo | Centerleder, professor | ||
| Wested, Jakob | Lektor | +4535331003 |
Funded by
The project has received one year of funding from the Center's 'Seed money'-pool 2021
Project: Representative clinical trials - Developing policies for neglected populations (DePNeP)
Period: 2021-2022
Extended: June 2023
Contact
 |
Jakob Wested Industrial post doc Det Juridiske Fakultet/ Lægemiddelstyrelsen |