Breaking new ground for the development of treatments for millions of patients with heart diseases in Europe
By Marilena Vrana, Manager Patients and Research, European Heart Network
Facing the challenge of cardiovascular disease
Almost 49 million people are living with cardiovascular disease (CVD) in the European Union, costing an estimated €210 billion each year overall to the EU economy. Of the total cost, around 53% (€111 billion) is due to health care costs, 26% (€54 billion) to productivity losses and 21% (€45 billion) to the informal care of people with CVD[i].
Atrial fibrillation (AF), heart failure (HF) and acute coronary syndrome (ACS) are major drivers of CVD. Currently, the management of AF, HF and ACS is complicated by their complex aetiology and heterogeneous prognoses. This renders the response to therapy unpredictable, with large variations amongst individuals and, importantly, small or undetectable treatment effects in large trials of patients. Also, tolerability of medications and adherence to current treatments shows wide variations. Aside from the medical need, drug development pipelines from early target validation through to late post-marketing work have proven to be slow and high-risk. The lack of high-resolution biomarkers and computable definitions frustrates progress in the development of successful CVD therapies. There is a clear need for a better definition of these three CVD conditions through improved biomarkers and endpoints, as well as its outcomes and prognoses.
The Big Data revolution has brought personalised medicine to several diseases, but cardiovascular care is stuck in the past. The BigData@Heart initiative aims to change that.
What is the project about?
BigData@Heart is a public-private partnership funded by the EU/EFPIA Innovative Medicines Initiative 2 (IMI2). It brings together a consortium of nineteen key players and stakeholders in the CVD field to apply Big Data approaches to AF, HF and ACD in Europe today[ii].
Thanks to the unique partnership, BigData@Heart has access to most of the relevant large-scale European databases, ranging from electronic health records and disease registries through well-phenotyped clinical trials and large epidemiological cohorts covering more than 5 million cases. By accessing and harmonising European-wide data sets, the ambition is to design prognosis algorithms which can predict the evolution of disease based on previous medical history, hospitalisation and country-specific statistics.
Unlocking the innovation potential
The project will develop and test a framework that will enable big data driven cardiovascular research, including the development of:
- New definitions of diseases and outcomes that are universal, computable, and relevant for patients, clinicians, industry and regulators.
- Informatics platforms that link, visualise and harmonise data sources of varying types, completeness and structure.
- Data science techniques to develop new definitions of disease, identify new phenotypes, and construct personalized predictive models.
- Guidelines that allow for cross-border use of big data sources acknowledging ethical and legal constraints as well as data security.
The ultimate impact on science, industry, policies, and patients includes a better understanding of heart diseases, the development of new therapy targets, improved drug and device development/utilisation, and the laying of the scientific foundation for a forward leap in the personalised treatment and management of CVD.
For more information http://www.bigdata-heart.eu/
[i] Wilkins E, et al (2017). European Cardiovascular Disease Statistics 2017. European Heart Network, Brussels. Available at: http://www.ehnheart.org/cvd-statistics.html
[ii] The team connects clinical researchers, leading epidemiologists, big data scientists, leading cardiovascular practitioners, patient organisations and the pharmaceutical industry. https://www.bigdata-heart.eu/Partners
