BigData@Heart Stakeholder Event - July 2020

7th July 2020 (14:00-16:00 CEST) – virtual meeting

With the rapid development in health data science in recent years, in particular around electronic healthcare records and associated coded outcomes, there now exists a gap between technical innovation and robust clinical evidence. For example, the broad use of coding schemes for outcomes in both observational and randomised research that lacks any structural basis or minimum quality requirements.

In this context, the BigData@Heart Consortium, which is a jointly funded by the EU and industry to address key unmet needs in cardiovascular data science, organised an online stakeholder meeting on July 7^th, 2020 to guide future research and clinical decision support by raising awareness of current limitations and providing a framework for best practice approaches for

ascertaining the quality and adequacy of coding, and
integration and harmonisation.

The event brought together regulators, journal editors, industry, funders, payers, patients and cardiology professionals within the European Society of Cardiology.

Scientific experts and key opinion leaders were assigned to a breakout session - (1) Definitions of disease in EHRs & the need for common standards, or (2) Coding equivalence and implications for clinical trials.

The BigData@Heart online meeting will prepare the groundwork for an in-person meeting on October 26^th, 2020 to be held at the European Heart Agency in Brussels (10:30 until 16:00 local time).

There will be an iterative process, so the online meeting, in person meeting and offline communications and drafts will all contribute to a final white paper.

Agenda of the Meeting

Time	Topic
14:00 to 14:15	Introductions [Chair: Dipak Kotecha]
14:15 to 14:45	Stakeholder perspectives – Challenges & opportunities Journal Editor perspective [Rupa Sarkar, Lancet Digital Health] Regulator perspective [Xavier Kurz, EMA] Professional & Guidelines perspective [Stephan Achenbach, ESC]
14:45 to 15:30	Breakouts: The landscape of contemporary real-world data evidence 1. Definitions of disease in EHRs & the need for common standards [Lead: Tom Lumbers; Moderator: Folkert Asselbergs; Plenary feedback: Angela Wood; Slides: Carl Steinbeißer] What is the pathway from event to coding and what are the implications of the diversity of coding standards? What are the challenges in terms of data validation, access, interoperability and transparency of data sources? Do the pros of data linkage outweigh the cons? How do we bridge the gap between the needs of different stakeholders? 2. Coding equivalence and implications for clinical trials [Lead: Stefan Anker, Rick Grobbee; Moderator: Dipak Kotecha; Plenary feedback: Maureen Cronin; Slides: Cinzia Ceccarelli] Do we accept clinical data from routine practice (blood pressure, weight, laboratory measurements extracted from EHR)? Do we accept adverse events collected from the EHR? How about SAEs? Should publication of coding schemes be a pre-requisite for trials? What is the equivalence of EHR-outcomes compared to adjudication? What is required for regulatory purposes and guideline change?
15:30 to 15:45	Plenary [Chair: Folkert Asselbergs; Angela Wood; Maureen Cronin]
15:45 to 16:00	Planning for face-to-face meeting & intermediate work [Chairs: Folkert Asselbergs; Dipak Kotecha]

Find out more about the faculty

Participants

Name	Role/Representation
Gunnar Brobert	Bayer
Andrea Derix	Bayer
Lothar Roessig	Bayer
Tiago Villanueva	British Medical Journal
Stefan Anker	Charité - Universitätsmedizin Berlin
Ceri Thompson	European Commission
Thomas Lüscher	European Heart Journal
Filippo Crea	European Heart Journal
Susanne Logstrup	European Heart Network
Marilena Vrana	European Heart Network
Xavier Kurz	European Medicines Agency
Stephan Achenbach	European Society of Cardiology
Dan Atar	European Society of Cardiology
Martin Cowie	European Society of Cardiology
Panos Vardas	European Society of Cardiology
Stephan Windecker	European Society of Cardiology
Valentina Tursini	European Society of Cardiology
Cinzia Ceccarelli	European Society of Cardiology
Ileana Piña	Food and Drug Administrations’ Center for Devices and Radiological Health
Martin Ingvar	ICHOM
Salome Koussoroplis	Innovative Medicines Initiative
Adrian Jonas	National Institute for Health and Care Excellence
Wim Goettsch	Netherlands Healthcare Institute
Benoit Tyl	Servier
Carl Steinbeisser	Steinbeisser Project Management
Kees van Buchove	The Hyve
Stuart Spencer	The Lancet
Rupa Sarkar	The Lancet Digital Health
Amitava Banerjee	University College London
Tom Lumbers	University College London
Spiros Denaxas	University College London
Harry Hemingway	University College London
Folkert Asselbergs	University College London / University Medical Center Utrecht
Angela Wood	University of Cambridge
Rick Grobbee	University Medical Center Utrecht
George Gkoutos	University of Birmingham
Dipak Kotecha	University of Birmingham
Maureen Cronin	Vifor Pharma
Jen Taylor	Medical Writer

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BigData@Heart Stakeholder Event - July 2020

7th July 2020 (14:00-16:00 CEST) – virtual meeting

Agenda of the Meeting

Participants