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

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

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.

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

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

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. 

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

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.

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

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.

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

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.

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.

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.