On the 13th September 2017, leaders of the BigData@Heart consortium held their first public webinar to introduce and outline the objectives of the Big Data for Better Hearts project that was launched in March this year.
BigData@Heart is funded by the Innovative Medicines Initiative (IMI), a public-private partnership between the European Union and the European pharmaceutical industry, and is part of their Big Data for Better Outcomes (BD4BO) research programme. The project is supported by a budget of € 19 million and will run for 5 years. The consortium consists of 19 stakeholders, including the European Society of Cardiology (ESC), numerous European academic research groups, and the European Federation of Pharmaceutical Industries and Associations (EFPIA). They will be working collectively under the IMI2 funding scheme, with the aim of applying big data approaches to improve patient outcomes in the most common cardiovascular diseases in Europe today: acute coronary syndrome, atrial fibrillation and heart failure.
Diederick E. (Rick) Grobbee, Professor of Clinical Epidemiology, University Medical Center Utrecht opened the webinar by introducing the rationale behind the project and its general structure. He described how progress in drug development for cardiovascular disease is frustrated by questions about definitions of disease, a lack of approved relevant patient-centred outcomes and data access being limited to selected small patient populations. He explained how these factors result in a mismatch between trials and real-world patients, and reflect a large inter-individual variation in prognosis and treatment response. The hope is BigData@Heart can usher in the next revolution in “big data” science to address these issues. The project is structured into 5 technical Work Packages (WP) including
- Project Management (WP1)
- Outcome Definitions (WP2)
- Data Harmonisation (WP3)
- Data Enrichment (WP4)
- And Data Analysis (WP5)
BigData@Heart also emphasises the importance of the Ethics, Legal and Data Privacy element (WP7), since working with enormous data sets presents challenges for protecting the privacy of individuals, whilst at the same time allowing for learning from the data that those individuals provided. Finally, Professor Grobbee highlighted ESC’s responsibility for keeping the professional community informed of the progress of the project. They will lead the Work Package for communication of results and guidance documents (WP6).
Overall, BigData@Heart hopes to create:
- New definitions of diseases and outcomes that are universal, computable, and relevant for patients, clinicians, industry and regulators;
- Informatics platforms that allow to link, visualize and harmonise data sources of varying types, completeness and structure.
- Data science techniques to develop new definitions of disease, identify new phenotypes, and construct personalised predictive models.
- Guidelines that allow for cross-border usage of big data sources acknowledging ethical and legal constraints and data security.
Folkert Asselbergs, Professor of Cardiovascular Genetics at University Medical Center Utrecht and BigData@Heart’s scientific coordinator, described each of 6 cross-cutting case studies that have been designed to facilitate the technical Work Packages and allow the consortium to implement short-term deliverables.
In case study #1, the consortium will compare real world heart failure patients with trial patients to guide inclusion and exclusion criteria for future trials and address the issue of mismatch between trial and real world data. Literature reviews show around 70 % of cardiology trial patients do not match real world patients and that real world heart failure patients are usually older, more often female and have more co-morbidities than those included in clinical trials.
Case study #3 will compare clinical outcomes derived from public registries with formally adjudicated endpoints. This study is particularly important for influencing future phase IV studies looking at how drugs are used in clinical practice and in patients other than those included in the original clinical trials.
Case study #4 aims to harmonise the national registries and electronic health records of Sweden, The Netherlands, The United Kingdom and Spain and map them to a common data language for analysis.
Case study #6 will investigate how data from wearables/Apps can be used as pre-market and post-market evidence in heart failure trials, tracking the burden of arrhythmia and atrial fibrillation. This will based on initial research by the IMI programme, Remote Assessment of Disease and Relapse – Central Nervous System (RADAR-CNS), who developed new ways of monitoring patients using wearable devices and smartphone technology.
Panos Vardas, Chief Strategy Officer, European Heart Agency focussed his presentation on the IMI itself, Europe's largest public-private partnership, and its mandate to support and accelerate the development of better and safer medicines for patients. He outlined how BigData@Heart will harness the assets available through the ESC to contact the key thought-leaders involved in Cardio-vascular research including those in Europe’s universities, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators to ensure the project’s success.
The final speaker, Gunnar Brobert, Director of Epidemiology, Bayer AG presented an overview of IMI’s Big Data for Better Outcomes (BD4BO) research programme, focussed on Alzheimer’s disease, hematologic malignancies, cardiovascular diseases and prostate cancer, and the roles of the DO→IT consortium (Big Data for Better Outcomes, Policy Innovation and Healthcare System Transformation), the overall coordinator of all BD4BO activities within IMI2.
Maureen Cronin, Consultant, Vifor Pharma joined the Q&A session moderated by Duane Schulthess, Managing Director, Vital Transformation that took place during the second half of the webinar. Audience members listening online were able to submit comments and questions to be addressed by the speakers during this session.
Tessa Richards, Senior Editor/Patient Partnership, British Medical Journal asked;“How this big initiative is systematically involving patients?”. Panos Vardas explained that the European Heart Network, one of the Consortium partners, will liaise and communicate with its patients’ group, which has a wide reach to patients across Europe.
When asked about patient involvement from the point of view of Bayer, Gunnar Brobert stressed that patient engagement is important for the pharmaceutical industry and noted that Bayer have specific engagement programmes and projects to ensure that patients are participating with them in BigData@Heart.
Maureen Cronin stated that, “the key to a big data approach in this type of project is that patients understand what we want to achieve.” She added that all of the data privacy, legal and ethical issues around data ownership are huge and, “if patients don’t understand them, it can often lead to barriers for this type of approach to innovation and that’s why it’s crucial to have them on board.”
Scott Wagers, Chief Executive Officer, BioSci Consulting asked “Do you have a strategy for when because of ethical, legal or local policy issues the data cannot be transferred across borders?”.
Folkert Asselbergs acknowledged that this is a problem due to differing regulatory requirements between the countries involved in sharing individual patient data. He said they will, “take a federated approach, where you send out scripts that run locally within the firewalls of the institutes and there share the output and summary files of the scripts to analyse them at a central location.”
Maureen Cronin highlighted The Coordinating Support Action, broadly providing oversight for all BD4BO projects ongoing in the EU, where they will share best practices in overcoming barriers. She specifically mentioned how WP7 will investigate data privacy, as well as the many ethical and legal issues associated with BigData@Heart. She concluded by saying, ”With what is going on in the US with the Precision Medicines initiative, we need to be sure that the EU is not left behind just because of its complex organisation and structure.”
The webinar concluded by highlighting that any SME or organisation interested in participating in BigData@Heart can contact the consortia via the website at www.bigdata-heart.eu
A video archive of the webinar is available here
PPT presentations can be downloaded here
BigData@Heart is a project under IMI2, which is the second phase of the Innovative Medicines Initiative (IMI) under the EU Horizon 2020 framework. IMI2 is a public-private partnership of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Commission.
For further information on BigData@Heart, please contact:
University Medical Center Utrecht
Linsey van Bennekom
L.vanBennekom@umcutrecht.nl
For general questions on the Innovative Medicines Initiative, please contact:
Catherine Brett
External Relations Manager
Innovative Medicines Initiative
catherine.brett@imi.europa.eu
Tel: +32 (0)2 541 8214