Voice of EHDEN Episode #6/Season 2 - 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 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.

Voice of EHDEN Episode #5/Season 2 - 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.

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.

Voice of EHDEN Episode #4/Season 2 - 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 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.

Voice of EHDEN Episode #3/Season 2 - 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.

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.

Voice of EHDEN Episode #2/Season 2 - An international perspective with the OECD on utilising RWD for healthcare system benchmarking and information systems with Jillian Oderkirk

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.

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

Voice of EHDEN Episode #1/Season 2 - Health Technology Assessment (HTA), RWD/RWE and EHDEN: enhancing methods, learning and the evaluation of therapeutics with Dalia Dawoud and Eline van Overbeeke

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.

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

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