The EHDEN Project – Meeting 21st century complexity in healthcare decision-making

Healthcare is rapidly increasing in complexity for everyone. As we generate new biological insights, mirrored with new approaches to treating disease, healthcare as an industry is greater challenged in meeting ever-growing need.

For patients, trying to understand the reasons for being ill, how to treat their illness, and probably most importantly, the implications for risk of morbidity, co-morbidities and mortality, is difficult without up-to-date information. The worldwide web’s inception in the 1990s has irreversibly changed how information is accessible, although ensuring accuracy and quality remain problematic. Furthermore, novel digital technology is increasing the ubiquity of sensors, wearables and biomarkers that provide additional, even real-time insights.

For healthcare professionals, diagnosis is only the first step in a therapeutic journey where the potential route and outcome for a patient, or a population of patients, can be at times vague or difficult to differentiate. As such, decisions on treatment can be trial and error in evaluating responsiveness of the disease and the patient.

To facilitate this, government and payers need evidence to better understand what treatments and healthcare provision to reimburse -- and Health Technology Assessment has become the mainstay of rigorous analysis of value of new treatment interventions.

In the 21st century, new technologies and understanding are revolutionising medicine, but with these developments, we see new challenges. Most of all, and despite the remarkable rise in data being generated at the patient-, population- and institutional level, we continue to face notable knowledge deficits. One might say we drown in data, but thirst for knowledge.

To this end, and within a Europe that is working to establish commonality of data use across the region (a common digital market), with porous digital borders and portability of data, the Innovative Medicines Initiative (IMI) has initiated within its framework, The European Health Data and Evidence Network (EHDEN). EHDEN is a consortium of twenty-two partners, eleven public, led by the Erasmus Medical Centre, and eleven pharmaceutical companies, led by Janssen. It is also part of the IMI2’s Big Data For Better Outcomes (BD4BO) initiative, and collaborates with the BD4BO disease-specific projects, the European Medicines Agency and other relevant organisations.

The project is an investment, 50 per cent from IMI (paying for the public partners), and matched funding from the industry in-kind, and in-cash towards a five-year programme to address critical knowledge gaps for all stakeholders described earlier.

The project is focusing around three key pillars: infrastructure; research use cases; and education and community building. Essentially, EHDEN will work to harmonise clinical data, derived from electronic health records in hospitals, primary care networks, and integrated regional databases, and to facilitate analysis of such data. At the heart of the project is a Harmonisation Fund, €17 million, to support the cost of mapping data to a common data model, the Observation Medical Outcomes Partnership (OMOP) model, within the international Observational Health Data Sciences and Informatics (OHDSI) framework.

OHDSI is an open science community, supporting data harmonisation, which facilitates distributed analysis for research at an unprecedented scale. EHDEN is set to accelerate the adoption and uptake of the OMOP common data model, and the OHDSI tools and methodologies across Europe, will speed up the process to generate reliable evidence, whilst ensuring transparency and reproducibility. To assist this process, EHDEN has two open calls, one for Small- to Medium-sized Enterprises (SMEs) who wish to be trained and certified in mapping with a common methodology (piloted in April 2019 with a first call), and a parallel call for data partners who wish to have both their data mapped, and also to join the open science community (initiating in late June 2019).

EHDEN will use a number of research use cases, focusing around outcomes, as well as other areas of interest, to both validate the development of this federated network, where data stays local, and to illustrate the ability to run research queries within the EHDEN community. The project will develop a platform for the generation of reliable evidence, containing a database catalogue (based on a prior IMI1 project, the European Medical Information Framework, EMIF), OHDSI and allied analytical tools, and tools for federated study execution. The federated network meets the need for privacy by design under the General Data Protection Regulation (GDPR), which became law in May 2018, and ensures continued compliance to protect patient data at a local level, where EHDEN brings the question to the data, not the other way around.

In the third pillar, the project will develop an online EHDEN Academy as an educational resource for those data partners, and SMEs, but also eventually for all other prior described stakeholders, with regards to the data science, bioinformatic technology, and research methodologies. Alongside this, EHDEN will build an open science community that can learn from, and link to the wider OHDSI global network.

What will be critical is sustainability of EHDEN beyond the IMI project duration, with the project phase ending in 2024. No doubt, multiple models will be required for both sustainability, with a need for support from all stakeholders, and at the highest level in the EU, in how research is conducted between data partners and researchers, be they academic, in industries, or at a governmental or payer level.

Success beyond 2024 will mean a Europe that can generate reliable answers to complex medical questions at a higher speed, and one that ultimately impacts positively on patient outcomes, irrespective of disease and geography.

The consortium is very keen to be playing a role in this endeavour, which can only happen with transparency, trust, a strong spirit of sharing, mutual interests being served, and keeping everyone updated on our progress in this collaborative journey.

Peter Rijnbeek (EHDEN Academic Coördinator)

Nigel Hughes (EHDEN EFPIA Co-lead)