Voice of EHDEN
Voice of EHDENSep 14, 2022
A conversation with Dr Eric Sutherland, Digital Health Lead, OECD on digital health ecosystems and the three layers of digital tools, integrated data and trusted analysis
We welcome Eric Sutherland, Senior Health Economist at the Organisation for Economic Co-operation and Development (OECD), which we covered in episode 2 of season 2 with Eric's predecessor, Jillian Oderkirk. Eric spent 20 years with a global bank in the financial sector, but wanted to fulfil his wish to be engaged and find meaning in his work, transitioning to roles locally and federally in health on data strategy. Having worked with the Canadian government on health data strategy development, Eric recently moved to the OECD, in particular focusing on the impact of digital tools and data on heath care delivery and outcomes within the overall health ecosystem.
In this conversation we start discussing Eric's definition of digital health, in his new role as Digital Health Lead at the OECD, and recognising there is no universal definition, but with a particular focus on technologies, interoperability and governance, linkage, quality of data, analytics and various intended use of health data. Against a context of incoherent fragmentation, Eric is focused on being able to produce useful guidance for countries to implement integrated digital health ecosystems, based on the three layers of digital tools, integrated data and responsible analytics.
Beyond this Eric outlines what he thinks is working today in digital health, and what's not, using an analogy of water, pipes and outlets to describe this, where we find ourselves too often drowning in data, but thirsting for evidence. Continuing to use this analogy we discuss how this all operates, who is responsible for the different elements, and some best practice use cases, such as OHDSI, or the FAIR principles, with ideas to promote conscious collaboration in making this all work. A lot of what we are trying to do is grow the digital health ecosystem by addressing technical fragmentation; the social, cultural, policy and process challenges; and trustworthiness (as opposed to trust alone).
In the end phase of this conversation, Eric outlines what he thinks are the priorities for Digital Health, with the three layers in mind, and a need for integrated care via multidisciplinary providers supported by integrated data, with a pivot to person-centric versus a facilities-centric philosophy. Inclusivity of new technologies to reduce non-value added tasks and activities while rationalising better data governance and data capture requirements could certainly beneficially impact on the workforce, lowering workloads and enhancing care delivery as one example. And as Eric points out, 'if we want to go fast, go alone, if you want to go far, go together'.
Some additional resources from the OECD:
- Canadian reports:
The views expressed by the participants are personal and not necessarily reflective of their organisations.
Ethical, Legal & Social Implications #2: Exploring the concept of trust and health data with Dr Mackenzie Graham
The Voice of EHDEN podcast is pleased to continue our occasional ELSI series, and this is the first episode of season 4, focusing on the concept of 'trust' within the context of health and health research, and in particular real world data. In this episode we are joined by Dr Mackenzie Graham, Senior Research Fellow in Data Ethics, Wellcome Centre for Ethics and Humanities, University of Oxford. Mackenzie has a facinating background in neuroscience, data and data ethics, and also collaborates with Dr Mark Sheehan and Dr Richard Milne, our participants in the first episode of our ELSI series.
In the discussion, we explore what is meant by, 'trust', and also trustworthiness, and reliance on appropriate governance systems to support individuals and patients being confident in who and how they can trust. Within this we investigate underlying concepts that result in trust, what it is and what it takes for trust and trustworthiness, such as motives and prior experience, very much within a motivation-based model.
Beyond this, we focus in on aspects of data use, the role of Tech Titans and trade offs we all make in society around the use of our personal data, through to sociotechnical architectures, e.g., Trusted Research Environments (TREs), federated data networks, like EHDEN, DARWIN EU(R) and the European Health Data Space (EHDS). From this the attributes, roles and actor's responsibilities are articulated, and a delineation of both passive and active activity around trust. Finally, we land on the counter factual concept of 'distrust' and the need to explore this further, especially in the context of health and health data use for research.
Specifically the role of TREs is explored in terms of trust, and Mackenzie and colleagues recently published in the Journal of Medical Ethics on, 'Trust and the Goldacre Review: why trusted research environments are not about trust', available here, and speaking to a number of aspects discussed in this episode.
The views expressed by the participants are personal and not necessarily reflective of their organisations.
2022, a remarkable year for us all, and for the European OHDSI and EHDEN communities, and looking ahead to 2023 a pivotal year for EHDEN and beyond
In our last episode of season 3 (delayed due to scheduling issues), we are delighted to invite back Prof Peter Rijnbeek, Chair of Medical Informatics at Erasmus Medical Centre, Rotterdam, Coordinator of EHDEN, Director of the DARWIN EU Coordination Centre, and Lead for OHDSI Europe, who usually ends each season of this podcast.
For this episode Peter reflects on the success of the OHDSI Europe symposium (24-26th June), held aboard the SS Rotterdam in the harbour and at Erasmus MC, with 350 registrants, 24 plenaries, 80 posters, a workshop and multiple OHDSI working group meetings. It was also an important timing post-COVID 19 lockdowns and was one of the first in-person OHDSI meetings, facilitating a return to networking and conversation not via video screens. The next symposium will be held in Rotterdam in June 2023, details will follow (keep an eye on the OHDSI Europe site).
Peter outlined the work of his group at Erasmus, and video interviews with his Post-Docs were conducted late in 2022 and are very informative on the their work in federated learning, AI/ML and utilising OMOP-mapped datasets, within Work Package 3 of EHDEN (here). In EHDEN we have reached 187 Data Partners in 29 countries, and 64 SMEs in 22 countries, a new community that did not exist pre-EHDEN, and now a new phase in completing industrial mapping to the OMOP CDM, but importantly the evidence generation phase local and regional, with emerging collaboration, sub-networks and national nodes already emerging.
In the conversation Peter outlines his own career development and the impact on his work focus and collaborations at Erasmus, in EHDEN and DARWIN EU, OHDSI Europe and Global. Using the experience also of the COVID-19 pandemic and the progress in EHDEN, we explore the advances and current challenges in the expansion of the use of the OMOP CDM, which is the glue in Peter's mind for the work we are all engaged in, and the post-ETL phase of using CDM-mapped datasets, iterating on tools, skills and methods and upskilling (via the EHDEN Academy). Needing high quality, rapid evidence, is a ubiquitous need, well characterised by the COVID-19 global public health emergency, where the opportunity for classical studies was limited.
In the last part of the discussion Peter speaks to his vision for the future of EHDEN, the focus on scientific advice and services, as well as training, and his confidence in sustainability. Furthermore, continued work within OHDSI, and in DARWIN EU, all point to a remarkable opportunity for European open science research in health, also with transition from the IMI EHDEN to the not-for-profit EHDEN.
The views expressed by the participants are personal and not necessarily reflective of their organisations.
The Voice of EHDEN will return in March for season 4.
An exploration of Health Data Research UK and UK Alliance - the Data Science Institution and its strategy for UK health research, and collaborating with EHDEN
In our penultimate episode of season 3, and this year, we are delighted to be speaking with David Seymour, Director of Infrastructure and Services, and Paola Quattroni, Head of Alliance Strategy & Engagement, at the Health Data Research UK (HDR UK) network, Data Science Institute, and UK Health Data Research Alliance. Both initally outline their careers to date, and both David and Paola have very applicable experience in working to ensure data utilisation by researchers in elderly care and oncology respectively.
We start with the history of HDR UK, the national institute of health data science, with a mission to unite health relevant data to enable discoveries that improve peoples' lives, with a 20-year vision to ensure advanced analytics to benefit every clinical interaction, clinical trials and public health (as seen with COVID-19). Founded in 2018, HDR UK is undergoing its 5-year review of what it has achieved and what it proposes to achive over the next 5 years, focused on three pillars, (1) delivering ground breaking research via its driver programmes, (2), bringing together infrastructure and services across the UK and internationally enabling large-scale data use in a trustworthy way, and (3), working through partnerships at a local level in the UK, as well as internationally, to meet its goals.
In the remainder of the episode, we discuss these there domains further, with respect to HDR UK, but also the development of the UK Health Data Research Alliance, in particular to ensure trustworthy use of health data, including patient and public involvement. We explore some of the challenges HDRUK and the Alliance have faced, and how the institution has responded to them, for instance with the use of the '5 Safes' framework.
EHDEN is delighted to be collaborating with HDR UK on the final Data Partner Call at time of this episode, with HDR UK supporting some of the UK applicants if selected and ongoing partnership with our combined network Data Partners in the UK and EU.
Ethical, Legal & Social Implications #1: The Concentric Circles Framework and working with health data through federated data networks
The Voice of EHDEN podcast is pleased to publish a new limited series on ethical, legal and social implications (ELSI) of working with health data for research, and this first episode with Dr Richard Milne, social scientist, Wellcome Connecting Science and the Kavli Centre for Ethics, Science and the Public, and Dr Mark Sheehan, philosopher, Oxford Biomedical Research Centre Ethics Fellow, both in the UK.
In our discussion, both Richard and Mark outline the work of the EHDEN Ethics Advisory Board/ELSI Group, and in particular publication of the development of a conceptual framework to assist the research community in understanding how to balance protections with value of the data for research. In a person-centric model, the Concentric Circles View (CCV), provides a structure where the researcher's relative position to the patient or subject, in a concentric circle, illustrates the extent of duty of care required.
The closer a researcher is to the subject in the model, the greater granularity and need for protection of the subject (compliance with law, privacy and confidentiality), whereas the further out, the data is often less granular, with less protections. It may be in the future that metadata will contain such relevant information to aid a researcher in understanding both the constraints on the use of health data, and their responsibilities in using it.
The EHDEN EAB/ELSI Group are looking further to explore the application of the CCV, especially in federated data networks like EHDEN, which are designed to address some of the challenges outlined in the CCV. The publication, in Frontiers of Big Data, can be found here, to accompany listening to this episode. A lay, non-expert version will also be produced in due course.
A perspective on health data, public private partnership and the pharmaceutical industry, with Magda Chlebus, European Federation of Pharmaceutical Industries & Associations (EFPIA)
In this fourth episode we have a conversation with Magda Chlebus, Executive Director, Science, Policy & Regulatory Affairs at EFPIA, exploring both her career and work in relation to health data, public private partnerships (IMI, IHI) and the importance of both to the Pharmaceutical Industry.
EFPIA is the representative federation of R&D-based pharmaceutical companies, creating a collaborative environment for its members to innovate, discover, develop and deliver new therapies and vaccines for the people of Europe. More recently, via IMI2, Partners in Research was created to also include non-pharmaceutical partners of EFPIA, recognising the diverse nature of collaboration today.
We start with exploring Magda's career, her current position leading the science and regulatory team, focusing on innovation policies and the regulatory process from development through to post-marketing authorisation of pharmaceutical products. Initially Magda started in public affairs in EFPIA, and points out that the reality we live in today for the pharmaceutical industry, started around 1995 with the creation of the European Medicines Agency, multiple legislation in clinical trials, paediatrics, patents, etc., with review of some of these, such as the pharmaceutial legislation review currently.
The Innovative Medicines Initiative (IMI) was also set up with the European Commission, and EPFIA, for a unique public private partnership programme, which Magda has been a long term champion of, especially in moving the 'data agenda' forward.
In the middle of the episode, we discuss the role of real world data from an EFPIA and pharmaceutical industry perspective, with evolving technologies and opportunities. Magda sees two key points for use of health data, in modernising the development of therapeutics, and in evaluating patient outcomes, with better delivery of care. We evaluate current developments, particularly moving from expert-led medicine, to evidence-based medicine, through to learning-based medicine.
Later we discuss aspects of trust, trustworthiness and transparency of purpose for the Industry, using benchmarks such as EHDEN, or IMI2 H2O, or indeed EMA's DARWIN EU as concrete use cases across the R&D continuum, as well as initiatives such as DataSavesLives. Towards the end of the episode Magda outlines her vision for the next five years or so, with a dream that the various strategies and documents are realised and do not stay on paper, being a big win for all stakeholders.
A conversation with Prof Paul Nagy, enhancing clinical decision-making and supporting future generations of practitioners as clinician researchers within a learning health system
Episode 3 of season 3, and a conversation with Prof Paul Nagy, Deputy Director, Johns Hopkins Medicine Technology Innovation Center, Associate Professor of Radiology and Radiological Science. Paul outlines his career trajectory that led to his current roles within Johns Hopkins, but also collaborating with OHDSI across multiple workgroups, inclusive more recently the Education WG. Paul started out in Radiology, originally as a Diagnostic Physicist, and was instrumental in developing international education programmes within biomedical sciences and informatics, and he has a real passion not only as an educator, but also in in empowering clinicians with data science and technologies.
In our conversation, Paul describes the multidisciplinary approach, team science, to support clinicians in reengineering care provision and improving patient outcomes. In OHDSI, he sees the strength of the various disciplines coming together to advance open science, again team science, and in utilising health data. Ultimately, being able to enhance the, 'wow', or, 'eureka' moment in the diagnostic experience will lead to more attuned diagnostic skill.
A particular focus for Paul is education metrics, and specifically psychometrics with reference to implementing, providing and importantly, evaluating educational interventions. A reference paper on psychometric evaluation, Developing and Verifying the Psychometric Integrity of the Certification Examination for Imaging Informatics Professionals | SpringerLink, is a must read in terms of understanding the perspective of Paul's and his colleagues' work in designing and reiterating design modifications to improve the outcome of education and its outcomes, for application by clinicians. Within the discussion, Paul utilises the imaging and radiology context to describe a real world use case of this work.
We go on to explore the developments in OHDSI, and more recent work in learning from this international system, such as the public psychometric dashboards on YouTube, PubMed, GitHub, MS Teams, etc., via https://dash.ohdsi.org, that can inform our understanding of applied education. Further work will assist in the design of OHDSI educational programmes, but also in facilitating how OHDSI can focus on reproducible evidence generation, via large-scale network studies, but also the tools, methods and skills used by OHDSI researchers. In the future, Paul would very much like to see how we can generate interoperability and connectivity of the OHDSI standardised analytical tools and educational resources for learning as you apply your skills and methods.
A rising star in the RWD/RWE domain, Prof Liesbet Peeters, her journey in addressing frustrations in working with data, and answering key questions in Multiple Sclerosis
In the second episode of season 3 we meet with Assistant Professor Liesbet Peeters, leading a research group at the Biomedical Research Institute & Data Science Institute, Hasselt University, Belgium, and the lead for the Multiple Sclerosis Data Alliance (MSDA). Liesbet has been described as a 'rising star' in the domain of real world data/evidence, and she had a very interesting path to her current position with a background in bioengineering, gene and cell technology, animal production, and veterinary science and focus on data.
We explore Liesbet's trajectory and work in the field of multiple sclerosis, the challenge with working with relevant and representative data, and in particular an 'accidental' interaction with the European Medicines Agency through a workshop, with key recommendations on enhancing the FAIR-ness of MS data. What has frustrated Liesbet is the inability to answer questions we readily ought to be able to, whether in MS or more widely. In working with colleagues, for instance the European MS Platform (EMSP), European Charcot Foundation. and others, Liesbet took the lead in creating the MSDA to respond to these frustrations over the last five years. Alongside this, Liesbet has been collaborating with e.g., EBRAINs, ELIXIR Belgium, DataSavesLives, et al, internationally and locally to address wider aspects of working with RWD/RWE. Liesbet outlines the details of collaborating and building and the complexity involved in the episode.
While Liesbet provides a fascinating insight into building a startup in working with data, she goes on to explore the recent work on COVID-19 and MS, answering critical questions quickly to address patient and clinician concerns as the pandemic emerged internationally. Beyond this Liesbet outlines her vision for the future, the collaboration with multiple stakeholders, initiatives and networks, but most importantly working with, 'amazing people'.
A future meeting, led by Liesbet and colleagues on 16th November in Baveno, Italy, on the, 'Use of Artificial Intelligence and Great Data to reveal progression in MS' is still open for registrations.
A personal perspective from Prof Dipak Kalra, President, Institute for Innovation through Health Data: a forty year view on systems, policies, technology and incentives
Welcome to this first episode of season 3, and a great way to start with a conversation with Prof Dipak Kalra, formerly a Primary Care Practitioner in London, UK, academic at University College London, and Ghent University, and President of the Institute for Innovation through Health Data (i~HD). Dipak is internationally known and renowned with a reputation for cogent and clear thinking around health data, data interoperability and quality, and policy development, with i~HD being a leading European-based organisation dedicated to advancing the field.
In this episode Dipak reverts back to his experiences in general practice in the 1980s, and the advent of electronic health records systems being introduced also to support use of data for research, albeit with underlying challenges around ethics and privacy governance, which of course still pervade to today. We discuss some of the challenges around ethics of data use, and privacy preserving aspects, as well as some of the more recent innovations, while focusing on the balance between risks of harms, versus benefits for patients themselves.
Dipak outlines the vision and direction of i~HD, from its origin in the IMI EHR4CR project, today and in the future, particularly regarding collaboration and safer use of health data, data quality, best practice, and policy development in this domain at a European level. Ultimately, i~HD acts as a neutral catalyst in addressing development and innovation. Lastly, Dipak describes the vision he has for health data use, RWD/RWE and a 21st century frameworks to meet the explosive need for evidence, , avoiding 'bureaucratic processes' and ensuring enhanced efficiency in generating RWE.
OHDSI Europe, EHDEN, the OMOP common data model and a new European research agenda in open science, where have we been and where are we going?
In our last episode of season 2, we are delighted to invite back Prof Peter Rijnbeek, Chair of Medical Informatics at Erasmus Medical Centre, Rotterdam, Coordinator of EHDEN, Director of the DARWIN EU Coordination Centre, and Lead for OHDSI Europe, who ended season one of this podcast discussing predictive analytics, and ends now season 2.
For this episode Peter reflects on the success of the OHDSI Europe symposium (24-26th June), held aboard the SS Rotterdam in the harbour and at Erasmus MC, with 350 registrants, 24 plenaries, 80 posters, a workshop and multiple OHDSI working group meetings, all for the back in person after the COVID-19 lockdowns. A number of highlights, in the science, in networking and collaboration and with regards to future developments are discussed, in particular the session on 10 countries in a 'cruise around Europe' and the growth of national networks or nodes, and evidence generation at scale. Peter goes on to explain OHDSI Europe, its work as a regional chapter of OHDSI, support of symposia, but also development of national nodes across multiple European countries, and reflecting on methodological and technical developments required for Europe itself in the CDM and standardised analytical pipeline.
In the middle of the episode, Peter explores the many proud achievements made by EHDEN, from the network development of Data Partners, training and certification of SMEs, implementation of the CDM at an industrial scale, and the move now to large-scale, rapid network analysis. The launch of the EHDEN Portal at the OHDSI Europe meeting is also a recent highlight. Ultimately, the remaining time of the IMI phase of EHDEN will be focused on illustrating evidence generation to improve patient outcomes, but also sustainability via an EHDEN not-for-profit that will parallel and then take over in 2024.
Lastly, we discuss the difference from the launch of EHDEN in 2018, to now and to 2024/2025 at the end of the IMI phase and beyond and what that may look like in a new Europe with mass adoption of the CDM, also exemplified with the recent initiation of the European Medicines Agency's DARWIN EU initiative, also based on the OMOP CDM and a federated model. Perhaps content for a future episode.
The views expressed by the participants are personal and not necessarily reflective of their organisations.
The Voice of EHDEN will return in September.
A new vision of conducting research with real world data, what have we learned from COVID-19, what is EHDEN doing and creative disruption with the OHDSI open science framework
We are delighted to be conversing with Prof Dani Prieto-Alhambra, Professor of Pharmaco and Device Epidemology, NDORMS, University of Oxford, UK, and part-time Professor of Real World Evidence, Erasmus MC, Rotterdam, and Research Coordinator for EHDEN. In this penultimate episode of season 2, Dani returns to the podcast (he also was in episode #2 of season 1) to discuss his perspective on evidence generation and conducting research with real world data today and a vision for tomorrow.
We start with exploring the differences (or not) between pharmaco and device epidemiology from Dani's experience, then go on to re-evaluating the research response to the COVID-19 pandemic, including inherent difficulties, and in particular evolving research in areas such as 'Long COVID' and sub-acute COVID that his group is leading. Clearly, there are implications for not only COVID-19, for e.g., vaccine use and safety, but also more widely for medical and health research, and in catching up with much that was challenged due to the pandemic. We cover the upcoming research priorities, inclusive of plans for study-a-thons and evidence-a-thons in EHDEN, based on a call for study proposals within the programme.
Following this Dani outlines how he sees research methods and collaborations changing now, for the better, and hopefully permanently, in using federated networks, distributed network analysis across geographies, supported by new platforms and technologies. He goes on to explain the use of study-a-thons and evidence-a-thons in EHDEN and OHDSI, and their emerging role in rapid analysis work to meet the challenge of responding to diverse research needs.
In the last third of this episode we discuss the paradigm shift we are seeing in terms of the creative disruption of the open science agenda and OHDSI research framework in EHDEN, in Europe, but also globally, inclusive of the Global South. Specific challenges such as reproducibility and transparency are also coming to the fore with our new methods in being able to be truly open, and with a need to collaborate. We take Dani back to his first exposure to OHDSI, the positive impact on his own career, but also the need to train and support a new generation of researchers where this paradigm shift today will be routine for them tomorrow. Moreover, and with COVID-19 in mind, we have changed science for the better, but we need to reinvigorate faith from certain communities in science globally.
The GetReal Institute - Putting Real World Evidence into Practice and learning by doing - improving the implementation of RWE in European health care decision-making
With a change to the schedule in episode #6, we meet with Shahid Hanif, Managing Director of the Get Real Institute (GRI), a year old organisation that originated from the IMI GetReal project (2013-2017) and the follow up GetReal Initiative (2017-2021). Shahid has a background in molecular biology and IT, before moving into policy work and several years with the Association of the British Pharmaceutical Industry (ABPI), consultancy, and then his current role. Shahid is now focusing on establishing the GRI, and the Institute has just announced its first 24 members, the conitnuation of the GetReal Academy and its future plans.
Shahid discusses the history of the GetReal programmes and the work on the GRI's foundation over the last year. The GRI has a legitimacy based on the prior programmes work, inclusive of ~50 publications and seminal papers, but also the development of an engagement with key stakeholders from patient groups to academia, industry and regulatory authorities. Meanwhile there was development of tools such as the RWE Navigator and Trial Tool, and the need to support their real world utilisation and applications, particularly in medicines development. The GRI's current focus ranges from reducing the adoption barriers to RWD/RWE, real world applications, such as in clinical trials, and decision support and confidence in using RWE, alongside upskilling via the Academy.
Following the retrospective look at the GRI's history to date, Shahid explores the current challenges in Europe and internationally, from representativeness and ethnic diversity, to adoption barriers to RWD/RWE, as well as ensuring confidence in the evidence generated by those receiving it. Collaboration, participation and ensuring equitable share of voice and attention are key themes in addressing responses to these challenges in the 21st century. While many focus on interoperability of data and analytics, interoperability of thought is part of the GRI's mission, acting as a nexus for stakeholders. Lastly, Shahid thinks ahead to what success could look like in 2026 for the GRI, based also on the prior five years and how the Institute has got to where it is today.
The curation of an open science community in Europe and sustainability of the EHDEN mission, a startup in the IMI programme
In episode #5 of the podcast, we meet with Carlos Diaz, CEO of Synapse Research in Spain, a specialist SME managing complex projects in IMI and Horizon 2020 (considered the number one SME), such as EHDEN, and formerly an economist and business administrator. Joining him is Johann Proeve, a biologist by training, who spent 36 years in clinical data management at Bayer Healthcare, and who ran the global data management organisation for 15 years, and who worked within IMI1 EHR4CR, and following retirement came back to Bayer to work in EHDEN. He is also the CSO of Cyntegrity, a risk-based quality management company. Carlos and Johann co-lead EHDEN's Work Package 6 focusing on value propositions, community, stakeholder engagement, education and training, and sustainability.
Both Carlos and Johann initially explore the emerging community of multiple entities and organisations in Europe, driven by the adoption of the OMOP common data model (CDM), and now having also worked on evidence generation based on this foundation. The coordination of the Data Partner and SME community via a Community Manager has been critical to this evolution, recognising the specific nuances of Europe, though work remains to be done in terms of being self actualising as a community from local to regional, with a levelling up in terms of geographical through to chronic to rare diseases representation. The discussion then explores the thinking behind the startup mentality ('running the project like a business'), especially as EHDEN now has two years left in the IMI phase, focusing on value streams and the establishment of the EHDEN not-for-profit entity, but most importantly the incentives driving everyone's involvement and the need to develop relationships.
Lastly, we focus on a thought experiment considering what success would look like two years after the IMI phase ends, in 2026, centering on a revolution in real world research within a self actualised, open science community.
Building the EHDEN Portal, the technical architecture to support open science in the EHDEN Community, addressing challenges and driving research innovation
Welcome to episode 4, discussing the architectural developments in EHDEN, within Work Package 4, co-led by Julia Kurps, Team Lead of the Real World Data Team, The Hyve, and Michel Van Speybroeck, Director, Data Sciences, Janssen. We explore the considerable opportunity, challenges and innovation required to develop a central Portal for EHDEN than can support research and collaboration between Data Partners and researchers.
Julia and Michel discuss their own unique backgrounds and careers, and then we investigate the work they are co-leading with WP4 colleagues across diverse public and private organisations to build the EHDEN Portal, central to both the sustainability and the use of EHDEN in conducting open science research using OMOP-mapped data at scale for network studies.
In the main body of the discussion, Julia and Michel outline what EHDEN is working to achieve with the Portal build, encompassing discoverability via a Catalogue through to standardised analytics (in collaboration with OHDSI) and an Evidence Hub. Furthermore, EHDEN is extending the OHDSI analytical tools, as well as supporting methodological aspects within an integrated framework, while incorporating processes, procedures and governance. Overall, this is within a wider ecosystem of Data Partners and researchers, inclusive of the Portal, but also training support via, e.g., the EHDEN Academy. Innovation, described in the discussion, has to be sustainable, inclusive of a wider and growing community of those who can conduct open science research themselves, with diverse use cases, such as in Health Technology Assessment, Pharmaceuticals, or with Data Partners, all who have specific expectations, requiring a balance within a technical architecture.
The Innovative Medicines Initiative, now Innovative Health Initiative, a unique public private partnership for Europe that provides the opportunity for start up projects like EHDEN
In episode 3, we speak with Colm Carroll, Scientific Project Manager at IHI (formerly IMI), to discuss the largest public private partnership (PPP) of its kind in healthcare, in the world, serving the European region. Colm discusses his own role, as well as IMI, running for more than a decade in driving innovation in healthcare, and the new IHI, which is widening scope and scale of the programme. We explore his role with the many, diverse projects he works with across the health data domain, including EHDEN.
Colm provides many insights into the opportunities afforded by IHI with regards to supporting public private collaborations through project consortia, addressing critical public health priorities for Europe, as well as facilitating the access to innovation in healthcare for EU citizens. We focus on impact being a key performance indicator for IMI/IHI, and explore the differences between IMI and IHI, in particular related to scope, processes and the widening of the private contribution from Pharmaceutical to include Diagnostics and MedTech. For anyone wanting to be involved in a project like EHDEN and the myriad of others, this is a very informative episode.
An international perspective with the OECD on utilising RWD for healthcare system benchmarking and information systems
In this second episode of season 2 we discuss an international perspective of using RWD to evaluate country healthcare systems and their information systems with Jillian Oderkirk, Senior Economist, Health Division at the Organisation for Economic Cooperation and Development (OECD), an intergovernmental economic organisation with 38 member countries founded in 1961.
Jillian provides a unique perspective from her global position on the health agenda of the OECD, and in particular the need to utilise data at scale to better understand healthcare systems, their impact at a national and international level with regards to quality evaluation, while assisting governments to improve their healthcare systems. Jillian has very relevant, prior experience in Canada, and with the OECD since 2010 in working with governments on assessing how they are transitioning from 20th century models of care provision and systems implementation to a 21st century, data-driven, learning healthcare system goal. In the conversation, we explore some of the more advanced countries, such as France, Finland, Denmark and South Korea with regards to realising this goal, as well as some deeper insights into countries like the Netherlands in OECD's most recent audit report (link).
The COVID-19 pandemic has acted as a lens on the problems everyone has with ensuring there is health data and information that is accessible and interoperable, with analytical interoperability, but also a catalyst for governments to prioritise improvements and policy responses to the persistent information deficit.
Within the discussion there is less emphasis on technical and methodological aspects of working with data, but more about governance, control and protection of health data, challenged by more nihilistic approaches to not utilising it in research to avoid perceived risks. Political and technocratic hurdles issues, such as parochial planning at local level, and the emphasis on reinventing versus copying best practice illustrate how the OECD is responding to this, such as with their 2016 recommendations on data governance (link). Fitness for purpose of information systems remains a key challenge, albeit with some pockets of improvement.
In the latter aspect of the episode we discuss future trends, and indeed hope for the 21st century goal Jillian has, demonstrated in programmes like EHDEN, and global open science collaborations such as OHDSI, based on transparency, reproducibility, collaboration and verifiable data interoperability.
Health Technology Assessment (HTA), RWD/RWE and EHDEN: enhancing methods, learning and the evaluation of therapeutics
In this first episode of season 2 we discuss Health Technology Assessment, a multidisciplinary, transparent process for evaluating therapeutic agents and technologies in terms of efficacy and value in treating the indicated population, within the wider context of a country's healthcare system. Joining us to discuss this is Dalia Dawoud, Senior Scientific Advisor at NICE, the National Institute for for Health and Care Excellence in London, and Eline van Overbeeke, Health Economics and Outcomes Research Manager, Pfizer, both co-leading work package 2 in EHDEN focusing on evidence generation in HTA and outcomes benchmarking.
In a broad ranging conversation Dalia and Eline, viewing this from a HTA agency and a biopharmaceutical company, cover what is 'HTA', and how RWD is rapidly growing as a data source for evidence generation to support contextual insights into therapeutic areas, longer term evaluation in-market, especially also where RCT data is minimal or absent, and in validation of modelling and assumptions. Challenges in utilising RWD are discussed, and how EHDEN is responding to this, for instance as addressed in the PharmacoEconomics paper of late 2019. Finally, we focus on the learning curve for all concerned and a forthcoming, initial module of courses related to HTA and use of RWD/RWE to be launched in the EHDEN Academy.
Using historical data to predict patients' future outcomes and exciting times for predictive, federated modelling
In this episode, we explore developments in predictive modelling and its growing impact in research and for clinical practice, with a focus on methodology, quality and lessons learned. Our guest in this episode is Peter Rijnbeek, Assoc Prof, Health Data Sciences at Erasmus MC, Rotterdam, and he is the Coordinator for EHDEN, in the leadership committee of OHDSI, and leading OHDSI Europe, as well as the OHDSI Predictive Modelling Working Group (with Jenna Reps, Janssen R&D). We start with briefly reflecting on the end of year three for EHDEN and the focus on evidence generation within the network of Data Partners. Peter covers initial basics of what is predictive modelling, the opportunities and challenges today, and demonstrative use cases across therapeutic areas, from Type 2 Diabetes, to Dementia, through to COVID-19. This final episode of season 1 finishes with the exciting prospects for expansion in this field, inclusive of a novel prediction model library being developed, but with the need to ensure transparency and reproducibility, as well a critical need for education across the field through to end users, clinicians.
The intricacies of data quality, the Data Quality Dashboard, and a new sub-specialty focus on data quality: a discussion with Clair Blacketer
In this episode we discuss a definition of data quality and some of the inherent challenges with real world data quality with Clair Blacketer, Janssen Epidemiology, OHDSI and Erasmus MC. Clair describes the work she and colleagues have been engaged in on the development of a criteria-driven Data Quality Dashboard (DQD). some recent publications (Blacketer, et al, and Blacketer, et al), and the impact of using the DQD and process with Data Partners from the EHDEN COVID-19 call (2020). We discuss the experience in the field of using the DQD and the insights on quality of source and mapped data, as well as the iterative stages in enhancing the quality of data in the Common Data Model. Finally, Clair discusses the emerging 'sub-specialty' of data quality and aspirations for the expansion of her and others work on the DQD. More information on the DQD can be found on the OHDSI GitHub here.
The EHDEN SME Directory & SME experiences with Data Partner mapping to the OMOP CDM
In this episode, we are pleased to speak with Andreas Kremer, Co-Founder of ITTM Solutions, Luxembourg, and Mark Rogers, ETL Product Manager, Imosphere, UK, representing two of our small-to-medium-sized-enterprises (SMEs), who are part of the expanding network of EHDEN-certified SMEs in Europe. They both share the impetus for joining this EHDEN programme, and discuss the experience and learning from working with Data Partners on mapping their source data to the OMOP common data model. Importantly, there are many levels of engagement, support and development beyond the focus on an ETL. Lastly, we speak about the future role of SMEs in European research more widely, and their integral role in enabling programmes, projects and initiatives utilising real world data.
Joining EHDEN as a Data Partner: experiences from UK Biobank and UCL
In this episode, we hear from Václav Papež, Research Associate at University College London (UCL), about the onboarding experience of UCL and UK Biobank as an EHDEN Data Partner. We discuss some of his latest research on defining phenotypes in data from electronic health records, his experiences with mapping data to the OMOP CDM with The Hyve in the IMI BigData@Heart project, as well as the recent EHDEN E-THON (Evidence-a-thon) and his experiences in participating in medical evidence generation in the EHDEN Network.
Improving the quality of cancer care for this and future generations: a conversation with James N'Dow about the EHDEN / PIONEER / OHDSI prostate cancer study-a-thon
Patient involvement with Open Science - a conversation with the European Patient Forum
In this episode, Gözde Susuzlu, Project Coordinator, and Estefania Cordero, Project Communications Officer, at the European Patients Forum discuss the rise of patient involvement in healthcare research, the need for support and digital literacy, and the role of such programmes as EHDEN. They explore the DataSavesLives initiative and the wider European Health Data Space (EHDS) development, finishing with the insights derived from the recent EPF survey conducted on the impact of the COVID-19 pandemic on patients and patient organisation.
The EPF 2021 Congress will be held virtually 26-29 October, more information here.
How open science is changing medical research in the era of COVID-19
In this episode, Dani Prieto-Alhambra, Professor of Pharmaco- and Device Epidemiology University of Oxford and academic lead for the work package in EHDEN focusing on the generation of real world evidence, talks about COVID-19, and how new, open science ways of working such as study-a-thons are influencing medical research.
Global open science and observational research: a conversation with international thought leader, Patrick Ryan, OHDSI & Janssen
In our first episode of season one, Patrick Ryan, PhD, VP Observational Health Data Analytics, Janssen R&D, Assistant Professor, Adjunct; Department of Biomedical Informatics, Columbia University Medical Center, and founding member of Observational Health Data Sciences & Informatics (OHDSI) joins us to discuss the last decade of OHDSI's and now EHDEN's methodological and tool development. We expand into COVID-19 and the pandemic's impact on observational research, and conclude by discussing OHDSI's educational remit and the need for upskilling in the research community.
The Global OHDSI Symposium is 12-15th September, 2021 - more information via OHDSI.org.
Voice of EHDEN Trailer
Welcome to season 1 of the Voice of EHDEN (VoE) podcast series. VoE will bring together a broad range of experts, all of whom are working at the edge of new developments with real-world healthcare data and large-scale research at all levels. They will share their first-hand experiences and help us gain a better understanding of the challenges and progress being made on this front. For more information about EHDEN, upcoming and past episodes, or to suggest future topics, please visit our website: www.ehden.eu