Podcasts – Voice of EHDEN season 3

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.

Listen to the episode here or via your preferred podcast app.

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 initially 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 achieve 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.

The views expressed by the participants are personal and not necessarily reflective of their organisations.

Listen to the episode here or via your preferred podcast app.

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.

The views expressed by the participants are personal and not necessarily reflective of their organisations.

Listen to the episode here or via your preferred podcast app.

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 pharmaceutical 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.

The views expressed by the participants are personal and not necessarily reflective of their organisations.

Listen to the episode here or via your preferred podcast app.

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.

The views expressed by the participants are personal and not necessarily reflective of their organisations.

Listen to the episode here or via your preferred podcast app.

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.

The views expressed by the participants are personal and not necessarily reflective of their organisations.

Listen to the episode here or via your preferred podcast app.

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 European 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.

The views expressed by the participants are personal and not necessarily reflective of their organisations.

Listen to the episode here or via your preferred podcast app.