Research focus areas of CORS
The projects are a collaboration between CORS, Pharmacovigilance Research Center, Biostatistics at department of Public health, and Data Analytic Center at the Danish Medicines Agency.
1. Project: Evidence combining RWD and RCT to inform regulatory and HTA decision-making
Objective: This study aims to provide insight into the best-practice methods and acceptability by decision-makers for combining RCT and RWD and comparing the properties of different approaches proposed in different data scenarios.
2. Project: Use of real-world data in optimizing drug safety data streams
Objective: To map and evaluate the interplay and utility of different data streams to support pharmacovigilance signal detection and safety surveillance.
3. Project: Using real-world data to address the efficacy-effectiveness gap
Objective: This study approaches the efficacy-effectiveness gap through 3 perspectives:
(1) Characterization of the gap between in-trial efficacy and real-world effectiveness over time
(2) Evaluation of the real-world effectiveness of regulatory recommendations (as described in the SmPC) over time
(3) Optimization of the recommendation for drug use at both the individual level and the public health level
Staff involved: Christine E. Hallgreen, Débora Dalmas Gräf, Haoxin Le, Lukas Westphal, Nikolai Constantin Brun, Morten Andersen
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.
Collaboration between the University of Copenhagen department of Pharmacy and H. Lundbeck A/S. Funding CORS partner: H. Lundbeck A/S. PhD candidate: Helle Christiansen (PhD project description).
CORS staff involved: Helle Christiansen, Christine E. Hallgreen.
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).
CORS staff involved: Christine E. Hallgreen.
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: Christine Hallgreen.
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.
CORS staff involved: Christine Hallgreen, Mathias Møllebæk
The overall aim of GRAVITATE-HEALTH is to promote adherence to treatment, safer use of medication, better health outcomes and quality of life through improved availability and understanding of health information from trusted sources and minimize risk through optimal use of available health information. The consortium will develop an integrated, digital, user-centric health information solution with two-way communication for the public, so as to make trustworthy health information available and understandable to both patients and public.
The Gravitate Health is a public-private partnership with 39 members from Europe and the US, co-led by University of Oslo (coordinator) and Pfizer (industry lead), funded by the Innovative Medicines Initiative (IMI) – a joint undertaking of the European Commission, the European Federation of Pharmaceutical Industries and Associations (EFPIA), IMI Associated Partners. Read more about the project.
CORS staff involved: Christine Hallgreen
Recent serious safety concerns with breast implants, hip replacements and vaginal mesh products in Europe have caused public concern about medical devices and how manufacturers and regulators are held accountable in the EU. In response, the European Commission introduced a new Medical Device Regulation (MDR) in 2017, which aims to reform the regulatory approach to balancing the need to bring new device technologies to patients with the need to protect public health. Yet, observers have argued that the MDR has not solved the underlying issues and instead introduced inappropriate and ineffective accountability requirements that place disproportionate burden on manufacturers and instill a false sense of reassurance with patients.
This project examines accountability mechanisms in the MDR and stakeholders’ perception of them within the wider context of European medical device governance. Accountability is defined in the narrow, legal-administrative sense as an institutional relation in which an agent (e.g. manufacturer) can be held to account by a forum (e.g. supervising body). Providing an analysis of medical device stakeholders’ interaction and the mechanisms that create accountability relations between them, the project asks: What are appropriate accountability mechanisms for European medical device innovation and how should they be evaluated? It employs a mixed-methods design that uses document analysis, qualitative interviews and a cross-sectional survey to integrate social network analysis, stakeholder and accountability mapping.
CORS funded project in collaboration with funding partner Novo Nordisk A/S
CORS staff involved: Mathias Møllebæk (PhD), Christine E. Hallgreen
The project aims at exploring the feasibility, sustainability and usability of creating and maintaining a regulatory science database, that collects in a (semi-) automated manner unstructured data from publicly available regulatory resources and transforms them in structured data ready to be sequentially analysed. The database will support the development of both a publicly available user interface to conduct (near) real-time descriptive analytics of regulatory process and output indicators, and an updated database for hypothesis-driven regulatory science studies in the functioning of the regulatory system.
The pilot project will focus on two use cases: Characteristics and follow-up of agreed Pediatric investigation plans in the EU; and description and follow-up of medicine-related safety issues evaluated in Pharmacovigilance Risk Assessment Committee (PRAC) – mapping PRAC safety evaluation process. The two use cases allow the exploration of two different phases of the drug life-cycle. This pilot project will provide a proof of concept for the creation of a regulatory science database. The intent is to further expand the database to include additional regulatory domains as well as additional regulatory regions. Overall, the goal is for the database to provide a basis for regulatory science studies, that can improve our understanding of whether regulatory instruments are having their intended impact and can help identify areas for improvement.
CORS funded project in collaboration with funding partner Novo Nordisk A/S
CORS staff involved: Mohnish Pandey (PhD), Christine E. Hallgreen
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.
CORS staff involved: Per Sindahl, Christine Hallgreen.
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.
CORS staff involved: Mathias Møllebæk, Christine E. Hallgreen.