Factors Affecting Citizen Trust and Public Engagement Relating to the Generation and Use of Real-World Evidence in Healthcare.

Denis Horgan,Birutė Tumienė,Minna Hendolin,Martina Von Meyenn,Dipak Kalra,Karen Facey,Bettina Borisch,Christine Chomienne,Nadia Georges,Amanda Cole,Allan Hackshaw,Arturo Chiti,Ivana Cattaneo,Mark Caulfield

doi:10.3390/ijerph19031674

Abstract

The potential for the use of real-world data (RWD) to generate real-world evidence (RWE) that can inform clinical decision-making and health policy is increasingly recognized, albeit with hesitancy in some circles. If used appropriately, the rapidly expanding wealth of health data could improve healthcare research, delivery of care, and patient outcomes. However, this depends on two key factors: (1) building structures that increase the confidence and willingness of European Union (EU) citizens to permit the collection and use of their data, and (2) development of EU health policy to support and shape data collection infrastructures, methodologies, transmission, and use. The great potential for use of RWE in healthcare improvement merits careful exploration of the drivers of, and challenges preventing, efficient RWD curation. Literature-based research was performed to identify relevant themes and discussion topics for two sets of expert panels, organized by the European Alliance for Personalised Medicine. These expert panels discussed steps that would enable a gradual but steady growth in the quantity, quality, and beneficial deployment of RWE. Participants were selected to provide insight based on their professional medical, economic, patient, industry, or governmental experience. Here, we propose a framework that addresses public trust and access to data, cross-border governance, alignment of evidence frameworks, and demonstrable improvements in healthcare decisions. We also discuss key case studies that support these recommendations, in accordance with the discussions at the expert panels.

Highlights

Major innovation in healthcare systems is often shaped by crises rather than strategic planning, as demonstrated by the recent explosion in data science during the COVID-19 pandemic [1]
We discuss the outcomes of these expert panels; we aim to provide a preliminary review of the challenges and successes associated with establishing a coherent approach to health policy within the European Union (EU), since strategic thinking, rather than infrastructure or the software associated with data handling, is the key to incorporating real-world evidence (RWE) to improve healthcare
In addition—and based on the discussions with our expert panel—we identified key recommendations aimed at addressing the barriers to implementation of RWE across Europe

Summary

Introduction

Major innovation in healthcare systems is often shaped by crises rather than strategic planning, as demonstrated by the recent explosion in data science during the COVID-19 pandemic [1]. The pandemic has posed multiple challenges, it has catalyzed progressive adoption of data and digital health policies forced by the pandemic-driven urgency to accelerate digitalization of healthcare systems and public awareness of the utility of patient-level data. Such real-world data (RWD), defined by the European Medicines. Interoperable and high-quality RWD, as well as a proportionate governance framework for their use, is needed to generate real-world evidence (RWE), which is critical for improving the understanding of the natural course of different diseases and of the benefit–risk profile of new and existing therapies, disease management, and healthcare provision.

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