At the European Health Forum Gastein on 5 October 2018, Big Data for Better Outcomes led a workshop on the value of evidence in outcomes-based healthcare. Shahid Hanif, Head of Health Data and Outcomes at the Association of the British Pharmaceutical Industry, represented DO->IT, the coordination and support action project of the Big Data for Better Outcomes programme. He presented a progress update on the programme and led a discussion on value in an outcomes-based healthcare system and approaches to generating real-world outcomes-based evidence.
Big data has enormous potential to provide more evidence to health care regulators, improve patient outcomes, and to transform European health care. However, to achieve this separate health data collection systems from different countries must be better coordinated and data sets better harmonised so that big data analytics can be applied. To do this, The Innovative Medicines Initiative (IMI) launched Big Data for Better Outcomes (BD4BO) in 2016 as a comprehensive European research programme with the broad ambition of shaping and transforming European health care systems and realising the potential of big data for promoting innovative methods via harmonising, accessing and analysing data.
Big Data for Better Outcomes is developing platforms for integrating and analysing diverse data sets, focusing on outcomes that matter to patients and generating meaningful insights that will help improve health care. It will aid accelerated and expanded access to data, more accurate measurement of outcomes, the development of personalised medicines and help decision-makers better manage their health care systems.
Big Data for Better Outcomes is an umbrella programme for several specific disease projects. It has attracted 50 private and public partners from across Europe with projects focusing on Alzheimer’s disease (ROADMAP), blood cancers (HARMONY), prostate cancer (PIONEER), and cardiovascular disease (BigData@Heart). Projects on more disease areas are in the pipeline. Patient groups are active contributors to each project and should be the main beneficiaries.
In the session, Shahid Hanif introduced recent advances in methodology from Big Data for Better Outcomes. This was followed by a panel discussion on the acceptability of such evidence for decision making by multiple stakeholders along the drug development and treatment pathway. The session highlighted some of BD4BO’s research and the importance of its findings in shaping future thinking around data use and value in outcomes-based health care. Shahid Hanif outlined the objectives and achievements of the disease-specific projects, each of which approaches access and use of data across Europe in a slightly different way.
ROADMAP has provided the foundation for a European-wide, integrated data environment and framework for real-world evidence across the spectrum of Alzheimer’s disease. It has developed new methods for collecting data and provided guiding principles and recommendations from Health Technology Assessment groups, payers and regulators for the development and incorporation of real-world evidence into clinical and market access development plans for Alzheimer’s disease.
HARMONY is one of the largest Big Data for Better Outcomes projects. The objective is to improve the outcome of patients with haematological malignancies through the use of Big Data sharing among all stakeholders. The project has developed a community of European haematological malignancies stakeholders, a framework for legal, ethical and governance issues enabling cross-border big data usage, and tools for analysing complex data sets including genomics data.
BigData@Heart focuses on cardiovascular diseases. It has a personalised disease approach, i.e. how to use biomarkers, how to characterise the different types of cardiovascular diseases, and how to take a personalised approach to treat cardiovascular diseases. It aims to develop a big data-driven research platform to deliver clinically relevant disease phenotypes, scalable insights from real-world evidence, and insights to driving drug development and personalised medicine.
PIONEER is the most recent disease-specific project in the programme. It began in January 2018 and aims to harmonise and analyse high-quality big data from diverse populations of prostate cancer patients across different stages of the disease to provide evidence-based data for improving decision-making by key stakeholders. It aims to improve prostate cancer-related outcomes, health system efficiency, and the quality of care delivered to patients as well as providing standardised care pathways for all clinical centres across Europe.
DO->IT (coordination and support action project) is an enabling project started in early 2017 and coming to an end in early 2019. It serves as the pivotal point of programme coordination providing expertise for communication, dissemination, and stakeholder engagement for areas common to all Big Data for Better Outcomes projects. It enables efficiencies across the BD4BO programme by sharing learnings in areas such as data privacy, methods for outcome selection and knowledge management.
2018 saw the start of the European Health Data and Evidence Network (EHDEN), an enabling component of the Big Data for Better Outcomes programme to deliver the vision of large-scale medical outcome research by developing a data network to enable other researchers to find and safely reuse data. The objective of this programme is to look at how to link data from different member states through a federated network. The ambition is to link data from hundreds of hospitals across Europe, covering about 20% of the European population.
The benefits of the BD4BO programme lies on multiple levels: facilitating the development of an outcome-based health care system, demonstrating the value of evidence generated from big data in each specific disease areas and benefiting patients. Enablers identified to improve health outcomes and expected achievements of the programme are the design of standard core outcome sets and their acceptance across countries, the creation of a data platform, increased access to high-quality outcome data, improved value for healthcare delivery, and increased patient engagement.
If you’d like to know more: see the recording of the workshop on the European Health Forum Gastein website.
About the Author: Muriel Guillier is Global Pricing Director at Pfizer, specifically supporting European countries. As part of IMI BD4BO initiative and alongside partners from LSE, she is co-leading work package 2 of the DO-> IT coordination and support action project which focuses on knowledge integration and management. LSE is leading the coordination of the DO->IT consortium.