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Health and Healthcare: Assessing the Real World Data Policy Landscape CHILDREN AND FAMILIES The RAND Corporation is a nonprofit institution that helps improve policy and EDUCATION AND THE ARTS decisionmaking through research and analysis. ENERGY AND ENVIRONMENT HEALTH AND HEALTH CARE This electronic document was made available from www.rand.org as a public INFRASTRUCTURE AND service of the RAND Corporation. TRANSPORTATION INTERNATIONAL AFFAIRS LAW AND BUSINESS NATIONAL SECURITY Skip all front matter: Jump to Page 16 POPULATION AND AGING PUBLIC SAFETY SCIENCE AND TECHNOLOGY Support RAND TERRORISM AND Browse Reports & Bookstore HOMELAND SECURITY Make a charitable contribution For More Information Visit RAND at www.rand.org Explore RAND Europe View document details Limited Electronic Distribution Rights This document and trademark(s) contained herein are protected by law as indicated in a notice appearing later in this work. This electronic representation of RAND intellectual property is provided for non-commercial use only. Unauthorized posting of RAND electronic documents to a non-RAND Web site is prohibited. RAND electronic documents are protected under copyright law. Permission is required from RAND to reproduce, or reuse in another form, any of our research documents for commercial use. For information on reprint and linking permissions, please see RAND Permissions. This report is part of the RAND Corporation research report series. RAND reports present research findings and objective analysis that address the challenges facing the public and private sectors. All RAND reports undergo rigorous peer review to ensure high standards for research quality and objectivity. Health and Healthcare: Assessing the Real-World Data Policy Landscape in Europe Céline Miani, Enora Robin, Veronika Horvath, Catriona Manville, Jonathan Cave and Joanna Chataway, with contributions from IBM EUROPE Health and Healthcare: Assessing the Real-World Data Policy Landscape in Europe Céline Miani, Enora Robin, Veronika Horvath, Catriona Manville, Jonathan Cave, Joanna Chataway, with contributions from IBM Prepared for Pfizer Pharmaceuticals Ltd. The research described in this report was prepared for Pfizer Pharmaceuticals Ltd. RAND Europe is an independent, not-for-profit policy research organisation that aims to improve policy and decisionmaking for the public interest though research and analysis. RAND’s publications do not necessarily reflect the opinions of its research clients and sponsors. R® is a registered trademark © Copyright 2014 RAND Corporation Permission is given to duplicate this document for personal use only, as long as it is unaltered and complete. Copies may not be duplicated for commercial pur- poses. Unauthorized posting of RAND documents to a non-RAND website is prohibited. RAND documents are protected under copyright law. For informa- tion on reprint and linking permissions, please visit the RAND permissions page (www.rand.org/publications/permissions.html). RAND OFFICES SANTA MONICA, CA • WASHINGTON, DC PITTSBURGH, PA • NEW ORLEANS, LA • JACKSON, MS • BOSTON, MA DOHA, QA • CAMBRIDGE, UK • BRUSSELS, BE www.rand.org • www.rand.org/randeurope Preface In October 2013 RAND Europe and IBM were invited to support Pfizer to assess the real-world data policy landscape in Europe and this report documents the results of a short study conducted over six weeks. Real-world data (RWD) is an umbrella term for different types of data that are not collected in conventional randomised controlled trials. RWD comes from various sources and includes patient data, data from clinicians, hospital data, data from payers and social data. Through its use alongside traditional data sources such as clinical trials, RWD has the potential to provide new insights into medicines and their effects in the context of different patient groups. There are already examples of ways in which research has contributed to the provision, construction and capture of RWD to improve health outcomes. However, to maximise the potential of these new pools of data in the healthcare sector, stakeholders need to identify pathways and processes which will allow them to efficiently access and use RWD in order to achieve better research outcomes and improved healthcare delivery. Current efforts to improve access to RWD and facilitate its use take place in a context of resource scarcity. This provides incentives for the healthcare industry, care providers, policymakers and other stakeholders to align and coordinate their respective activities and carve out viable and productive regulation and practice. RAND Europe and IBM have worked together through a multi-method approach to assess different RWD pathways that the health and healthcare sector has explored and the options going forwards. Based on a literature review, case studies and a small set of interviews of experts from public and private organisations, the study outlines possible strategies to illustrate how RWD standards development could facilitate RWD-based research. For more information about RAND Europe or this document, please contact: Prof Joanna Chataway Tel. +44 1223 353329 [email protected] RAND Europe Westbrook Centre, Milton Road Cambridge, CB4 1YG. iii Table of Contents Preface ......................................................................................................................................................iii Table of Contents ...................................................................................................................................... v Tables ....................................................................................................................................................... vi Executive Summary ................................................................................................................................... 7 Acknowledgements .................................................................................................................................. 13 Abbreviations .......................................................................................................................................... 15 1. Introduction: The rise of RWD in health and healthcare research .......................................... 17 1.1. Origins and aims of the report .................................................................................................... 17 1.2. What is real-world data? ............................................................................................................. 20 2. Moving from data to evidence: the state of RWD in Europe .................................................. 27 2.1. RWD is useful for building the evidence base for drug development and post-market studies in the pharmaceutical and medical sectors ....................................................................... 27 2.2. RWD is increasingly used to improve healthcare service delivery ................................................ 29 2.3. Factors that influence access to and use of RWD ........................................................................ 35 3. Overcoming existing barriers through the development of standards to improve access to and use of RWD ............................................................................................................... 41 3.1. Overcoming content and quality issues ....................................................................................... 41 3.2. Overcoming methodological issues ............................................................................................. 49 3.3. Improving governance ................................................................................................................ 57 3.4. Developing privacy best practices ................................................................................................ 60 3.5. Summary of findings: main barriers to access to and use of RWD and strategies to overcome them ........................................................................................................................... 63 4. Conclusion ........................................................................................................................... 65 4.1. Summary of findings .................................................................................................................. 65 4.2. Understanding the role of RWD in the current political, societal and economic context ............. 66 References ............................................................................................................................................... 75 v Tables Table 1 Examples of RWD ..................................................................................................................... 21 Table 2 Examples of responsibility for data management ........................................................................ 23 Table 3 Areas for RWD use in health and healthcare .............................................................................. 24 Table 4 The EuResist initiative ............................................................................................................... 30 Table 5 National Cancer Institute of Milan: analytics and big data to improve cancer treatment ............ 31 Table 6 The Shared Care platform: using RWD to improve the efficiency of homecare delivery in Southern Denmark ........................................................................................................................ 32 Table 7 Partnership to reduce
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