Research focus areas of CORS
Click on the accordion to read more about our collaborative projects.
Impact of drug regulation on health
CORS funded project with the objective to provide insights into the effectiveness of the EU and US paediatric regulations to promote access to medicines for children as well identifying potential barriers of the paediatric regulations to innovative drug development in general. Ultimately, these analyses should serve to provide recommendations for improvements to the global regulatory frameworks for paediatric medicines development with a focus on the US and the EU.
This study compares safety advisories on medicines in Canada, the United States, the European Union (United Kingdom and Denmark), and Australia from 2005 to 2016. At a population level, we examine whether recommended changes to prescribing, other health-related behaviours, and health outcomes have occurred to a greater extent in countries with safety advisories than in those without advisories. The aim of the study is to identify best practices in regulatory risk communication on medicines, in terms of effects on medicine prescribing and use, and ultimately on public health.
Coordinator of the project, Colin Dormuth, University of British Columbia. Co-investigators are, Mintzes BJ, Sketris IS, Bero L, Davis C, De Bruin ML, Kesselheim A, Lexchin J, Mangin D, Moore TJ, Puli L, Roughead EE, Wiktorowicz ME. The project is funded by the Canadian Institute of Health Research (CIHR).
As a subcontractor to Utrecht University (NL), CORS participates through the Pharmacoepidemiology Research Collaboration Copenhagen (co-investigators Prof. Morten Andersen and Prof. Anna Birna Almarsdottir) in the consortium performing post-authorisation effectiveness and pharmacoepidemiology studies for the European Medicines Agency to generate data and information to support regulatory decision-making.
Under this collaboration, the following studies are being or have been performed:
- Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU (EUPAS 16014)
CORS staff involved: Marie L. De Bruin.
Emerging technologies & societal trends
This CORS-funded project aims to explore how different stakeholders interpret “similar,” and how these views impact the approval, development, and use of biosimilars.
Collaboration between the University of Copenhagen department of Pharmacy (Health and Medical Sciences) and the Centre for Advanced studies in Bio-medical Innovation Law (Faculty of Law). Funding CORS partner: LEO Pharma. PhD candidate Louise C. Druedahl (PhD Project Description)
CORS funded project that will monitor and explore the conditions for the development of FDC’s taking into account the differences in the available data for categories.
Collaboration between the University of Copenhagen departments of Pharmacy; Drug Design and Pharmacology; Public Health (Health and Medical Sciences), and Contera Pharma. Funding CORS partner:Novo Nordisk. PhD candidate: Asbjørn Nøhr-Nielsen (PhD Project Description).
The overall objective of HTx is to create a framework for next generation Health Technology Assessment that supports patient-centred, societally oriented, real-time decision-making for integrated healthcare throughout Europe.The mission of HTx is to facilitate the development of methodologies to deliver more customized information on the effectiveness and cost-effectiveness of complex and personalised combinations of health technologies. HTx will also provide methods to support personalised treatment advice that will be shared with patients and their physicians. The HTx consortium comprises fifteen partners, including academia, Univeristies, patient associations, SME’s, regulatory authorities and National Health Institutes, led by Utrecht University (The Netherlands). It will work in close collaboration with the European Network for HTA (EUnetHTA) and its stakeholders to pilot the implementation of these methods in Europe. The project is funded by the European Commission Horizon2020 program (read here the project press-release).
CORS staff involved: Marie L. De Bruin
As the importance of personalized medicine is increasingly being recognized, there is a need to re-think the way in which medicines are currently being produced. Pharmacoprinting with 2D and 3D printers is a relatively new technology for producing/compounding medicine. Especially 3D printing of medicine comes with many new opportunities for creating personalized pills or capsules with different doses and delivery mechanisms, and even individualized polypills that combine two or more APIs. However, it can also present some challenges such as legal, regulatory, organizational and societal changes.
Our aim is to understand the different aspects in which this new technology would influence the current manufacturing/compounding practices, in order to assess the feasibility and future success of implementing the pharmacoprinting of personalized medicine. We plan to achieve this aim by conducting in-depth interviews with different stakeholders who are expected to be affected by the implementation of this new technology, including regulators, suppliers, the pharmaceutical industry, pharmacies, prescribers and patients.
Post-marketing drug regulation
CORS funded project that aims to identify and understand the factors that determine the effectiveness of drug safety communication such as Direct to Healthcare Professional Communication and educational materials and sets out to present suggestions on how to improve the existing communication process.
Collaboration between the University of Copenhagen departments of Pharmacy (Health and Medical Sciences), Media, Cognition and Communication (Humanities) and Ferring Pharmaceuticals. Funding CORS partner: Ferring Pharmaceuticals. PhD candidate: Mathias Møllebæk (PhD Project Description).
The regulatory framework for medicines in the EU is evolving constantly. The system changes in order to adapt to scientific developments and increased expectations. With these changes comes also an increased risk of overlap and redundancy between procedures, pertaining to the data they evaluate and the objectives they examine. These changes demand a continuous reflection on whether or not the regulatory system is achieving its intended goals. The primary objective of this project is to evaluate the PSUR impact on patients’ safety in relation to other pharmacovigilance activities.
This project is a collaborative effort of the Danish Medicines Agency, The Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation and CORS.
Medicines have important health benefits but can also lead to harm. When new safety concerns arise, national regulatory agencies issue warnings to health professionals and the public. This study compares safety advisories on medicines in Australia, Canada, the United States, and the European Union in order to identify how to best protect public health. The focus is on new safety concerns for which the decision to communicate, methods used, or key messages differ between countries. The study includes policy analysis and interviews with clinicians and patient groups to better understand factors that enhance the effectiveness of safety advisories and how awareness and medicine use are affected.
Coordinator of the project, Dr Barbara Mintzes, University of Sidney Co-investigators are Roughead E, Lexchin J, Bero L, Dormuth C, Kesselheim A, Lipworth W, De Bruin ML, Gnjidic D, Puil L.
The project is funded by the National Health and Medical Research Council (NHMRC) Australia.