The European Health Data & Evidence Network

Transcription

1 The European Health Data & Evidence Network What is it? Nigel Hughes EFPIA Coordinator Scientific Director, JCI Patient Data for Research, Janssen 18 th May

2 All too often real world research is a challenging journey. 2

3 What we need is infrastructure and a network to conduct real world research in the 21 st Century. 3

4 Innovative Medicines Initiative IMI: a unique Public-Private Partnership (PPP) between the pharmaceutical industry represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Union represented by the European Commission. 4

5 Federated distributed data networks reflect real world patients with greater phenotypic resolution: big data 1 care Hospital Admin Regional Registries & cohorts Biobanks 2 care Paediatric RWD is about diversity of source as no one data source is the whole truth. A federated data network retains local provenance and governance while facilitating remote connectivity with RWD for research reuse OMOP Common Data Model COMMON DATA PLATFORM A federated data network is based around a common platform to facilitate bidirectional data flow, data harmonisation (from diverse sources) and connectivity for research reuse; supported by a harmonisation fund and certified/qualified SME network Academia Discovery Post- Authorisation Development HTA/Outcomes Collaborative research Pharmaco-epidemiology Basic science Natural history Translational research Biomarker development There are a multitude of use cases for RWD, but the more reflective of populations, cohorts and real world patient trajectories the more reliability can be attributed to RWD/RWE Study feasibility Strategic site/participant selection Adaptive/pragmatic/platform studies Regulatory commitments For value and outcomes Pharmaco-vigilance patients, their treatment License extensions episodes, and outcomes need to be tracked longitudinally across HEMAR health domains Health service planning Outcomes, value-based contracting 5

6 Key Components of Collaborative Data Projects. 6

7 EHDEN Public & EFPIA Consortium Working on Full Project Proposal EHDEN Institute Erasmus MC Synapse Research Management Oxford University Tartu Ulikool University of Aveiro The Hyve Odysseus Data Services European Patients Forum National Institute for Health and Care Excellence (NICE) Stiftelsen WHO Collaborating Centre for International Drug Monitoring International Consortium for Health Outcomes Measurement (ICHOM) Country The Netherlands Spain UK Estonia Portugal The Netherlands Czech Republic Luxembourg UK Sweden UK 7

8 Current Progress on EHDEN EHDEN is an IMI flagship project Key stakeholders and actors in this domain recognise the RWD RWE process in the EU is inadequate For the coming year pre-project preparation is critical for a Q4 start Key Activities Q1-Q3 Consortium Development Vision Alignment Final Project Proposal submitted 15 th May Work Packages Advancing Short Project Proposal Aligning Consortium Linkage with e.g. OHDSI Developing The Plan 8

9 EHDEN: Vision, Mission & Values Vision: The European Health Data & Evidence Network (EHDEN) aspires to be the trusted observational research ecosystem to enable better health decisions, outcomes and care Values: Mission: Our mission is to provide a new paradigm for the discovery and analysis of health data in Europe, by building a largescale, federated network of data sources standardised to a common data model 9

10 European Health Data & Evidence Network Representative and diverse real world data across the EU Adaptation of global open science initiative to EU needs A framework for 21 st Century real world research Impact: Meeting the needs of a single digital market for digital citizens in healthcare 10

11 European Health Data & Evidence Network Therapy and disease area agnostic Insights and evidence generation in the health domain Reflecting real world clinical management, care and outcomes Impact: enabling better health decisions, outcomes and care for the EU 11

12 European Health Data & Evidence Network Harmonised 100 million records, mapped to the OMOP common data model Ecosystem of certified/qualified SMEs harmonising data sources, supported by 17mio fund via open series of calls Federated analytics via OHDSI tooling, ARACHNE and EMIF platforms Impact: Improving trust and reusability of real world data for key stakeholders 12

13 European Health Data & Evidence Network Use case driven, incorporating PROMs/PREMs, digital biomarkers, and predictive analytics Incorporating ICHOM standards, HTA and Regulatory input on methodology Clinically meaningful evidence from research impacting on practice Impact: Evidence-driven improvements in patient outcomes, leading to precision medicine 13

14 European Health Data & Evidence Network A federated network of diverse, high quality data sources A collaboration based on mutual need and shared value propositions Governance and provenance remains local, supportive also of GDPR Impact: A region-wide well trained, active and sustainable open science community 14

15 EHDEN Proposed Work Packages WP1: Evidence Workflow Development WP2: Outcome Driven Healthcare WP3: Personalized Medicine WP4: Technical Implementation WP5: Data Workflow Implementation & Service Deployment WP6: Outreach and Sustainability WP7: Project Management and Dissemination Build Fuel Drive 15

16 EHDEN Proposed Work Packages Incorporating the use cases for supporting development and validation WP1: of Evidence the EHDEN socio-technical Workflow Development approach, inclusive of BD4BO projects Key priority is sociotechnical WP4: development Technical of the Implementation EHDEN federated framework and relevant services Concentrating on intraproject project WP7: Project management, internal Management and communications and Dissemination external dissemination, and responding to IMI deliverables Related to all activities specific to e.g. BD4BO projects WP2: Outcome outcome Driven focus, and ICHOM Healthcare standards incorporation Development, oversight and evaluation of the ecosystem WP5: Data development Workflow from Implementation SME qualification/ & certification Service Deployment to data source engagement, OMOP CDM mapping and evaluation Build Fuel Drive Focusing on the support of outcomes/value based healthcare, WP3: Personalized inclusive of clinical prediction Medicine models, with the incorporation of novel patient data Ensuring the development of value propositions for key WP6: stakeholders, Outreach and and developing Sustainability the sustainable operational model for EHDEN during and post IMI phase 16

17 EHDEN is not a blank canvas project. EHDEN will utilise the best from prior and current (IMI) projects and platforms to develop its own infrastructure It will be developing its federated framework, but also analytical tooling and processes to support observational research in the EU, closely associated with the OHDSI EU/Global Open Science/Open Source collaboration 17

18 Standardized clinical data Critical at the heart of EHDEN is the OMOP CDM and OHDSI Collaboration Person Observation period Specimen Death Visit occurrence Procedure occurrence Drug exposure Device exposure Condition occurrence Measurement Observation Note Note NLP Fact relationship Standardized health system data Location Payer plan period Cost Cohort Cohort attribute Condition era Drug era Dose era Care site Provider Standardized health economies Standardized derived elements Standardized meta-data CDM source Concept Vocabulary Domain Concept class Concept relationship Relationship Concept synonym Concept ancestor Source-to-concept map Drug strength Cohort definition Attribute definition Standardized vocabularies 18

19 What is the flow through EHDEN? Harmonisation Fund A multitude of data sources in the EU Engagement & Quid Pro Quo Workshop Use Cases, Demonstration Projects & Developing Evidence Audit OMOP CDM Mapping Source Data Evaluation Mapping Share of Mapping Process Research Developing the SME domain in the EU Qualification & Certification Process 19

20 EHDEN: In Summary EHDEN is a bold step in recognising that a flagship project is needed to address conducting real world research for the 21 st Century At its heart is the acknowledgement that we need to develop a community via a federated network, within an ecosystem, all based on a quid pro quo around data for research use The Open Science/Open Source community of OHDSI, and the OMOP CDM are critical enablers and partners for EHDEN in this endeavour 20

21 What is the European Health Data & Evidence Network (EHDEN)? The aim is to map 100 million health records across the EU via a common data model (OMOP), supporting research, the BD4BO IMI2 programme, and outcomes-based healthcare Advance the skill base in the EU via certified& qualified SMEs Harmonisation fund to support mapping to CDM Harmonisation Infrastructure Building on prior and current (IMI) projects Accelerate the platform and supporting research process Incorporation of outcome standards (e.g. ICHOM) Supporting the evidence base in the EU for outcomes-based research and medicine Outcomes Ecosystem A federated network of increasing number of Data Custodians and Sources Evaluation and incorporation of novel data sources Utilisation of FAIR Principles EHDEN will be an IMI consortium of 11 EFPIA partners and a public consortium of 11 partners, commencing c. October