Calling for more research into cardiovascular diseases
The burden of cardiovascular disease (CVD) is immense and greater than any other condition, yet CVD receives less research funding than other clinical areas.
The CardioScape project has shown that research in CVD is disproportionally low at European level and that the research landscape is particularly fragmented.
This comprehensive database of cardiovascular research aims to outline the current cardiovascular research and innovation landscape across Europe. It will provide information on the distribution and focus of funding in the cardiovascular field, and establish the extent of duplication across national research programmes and the existence of gaps that reduce opportunities for innovation.
Strategic Research Agenda
The ESC is calling for the incoming EU Framework Programme for Research, Horizon Europe, to reflect these research priorities and to ensure that research in CVD will receive the attention it deserves.
The Strategic Research Agenda for CVD, produced by the ERA-CVD Network in cooperation with the European Society of Cardiology and the European Heart Network, has identified key areas for which clinical research is needed if we want to succeed in reducing CVD mortality and morbidity. The top five research priorities identified are:
- Earlier recognition of cardiovascular disease
- Repair of the heart and blood vessels
- The interaction between CVD and other disorders
- Treatment of chronic heart failure and atrial fibrillation
- Personalised treatment and management of cardiovascular disease
Advancing innovation in cardiovascular medicines
Facing the problem
Insufficient investment in CVD research has resulted in a decrease in innovation in cardiovascular medicines. In 2018, no new CVD medicines with a new active substance were recommended for approval by EMA (while 11 new cancer medicines and 21 new orphan medicines were centrally approved). In 2019, only two new CVD medicines with a new active substance were approved (compared with five new cancer medicines and seven orphan medicines).
The causes of this decline include the high cost of clinical trials in cardiology and an unfavourable regulatory framework for fostering CVD innovation. Due to a combination of factors, including the need to base the assessment on large populations, clinical trials in CVD are more complex, larger, longer and more expensive than those for other conditions. The average pivotal CVD clinical trial costs three times more than its cancer counterpart and six times more than trials for most other diseases.
The excessive cost of cardiovascular trials is a major threat to the development of new treatments and has led several pharmaceutical companies to lower the priority of, or even end, developing CVD medicines.
Addressing the problem
The ESC is calling for the European Pharmaceutical Strategy to reflect cardiovascular regulatory framework and research funding, to address the issue of access to CV innovative medicines and treatments.
A regulatory framework is needed, with better and more flexible rules for the conduct of clinical trials (envisaging the use of novel technologies) and better-quality patient registries in CVD. This would allow the use of real-world data and the carrying out of registry-based studies.
EU Clinical Trials Regulation will bring some positive changes provided it abides by the revision of the current rules on the design and conduct of clinical trials set by the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) guidelines
Digital cardiovascular health
ESC and digital health
Digital health is transforming healthcare and the ESC is fully engaged in this critical new area.
ESC Advocacy supports the ESC work in the digital area by facilitating dialogue with relevant actors, including EU and national decision-makers to ensure the appropriate development and deployment of new solutions to advance cardiovascular health across Europe.
Find out more about ESC and digital health
Digital health at the EU
As a member of the European Commission’s eHealth Stakeholder group, the ESC has contributed expert advice for the shaping of EU policy on digital health. This included contributing to the draft of three policy reports covering the following topics: care continuum, citizen and health data, and reimbursement of digital health products and solutions. These reports provided the European Commission with a series of recommendations to move eHealth forward at the EU level.
The ESC also responded to two European Commission consultations that will shape the future EU policy and regulation in the digital area. In our responses to the consultations on the European Data Strategy and on the White Paper on Artificial Intelligence, we emphasised the importance of a harmonized EU-wide approach to health data, and have called for the creation of a Common European Health Data Space to support clinical practice and cardiovascular research.
European Health Data Space
To exploit the potential of ever-growing data in a trustworthy European framework, the Commission, in collaboration with the Member States, will put forward a legislative proposal on a common European Health Data Space.
A common European Health Data Space will promote better exchange and access to different types of health data such as electronic health records, genomics data and data from patient registries not only to support healthcare delivery (primary use of data) but also for health research and health policy-making purposes (secondary use of data).
ESC has shared its feedback on a roadmap published via an open consultation which will prepare the ground for legislation in 2022.
Call for experts in repurposing authorised medicines
The European Medicines Agency (EMA) has launched a pilot project to support the repurposing of established medicines.
The initiative is addressed to not-for-profit organisations and academia interested in repurposing an authorised medicine in an area of public health interest and with a scientific rationale for their repurposing programme, willing to seek scientific advice and regulatory support to gather or generate robust evidence.
Such evidence could support a future application by a pharmaceutical company and result in a formal regulatory authorisation of the new use. If you are interested, read the call for further details and apply here.