Directorate-General for Research and Innovation (DG RTD) has contracted PPMI to carry out the Study on the use of real-world data (RWD) for research, clinical care, regulatory decision-making, health technology assessment, and policy making.

Real-world data (RWD) is health-related data derived from a diverse human population in real life settings. RWD is a highly promising and developing area which offers benefits to all stakeholder groups, but requires a coordinated effort, pooling of resources and infrastructure, as well as additional investments to fulfil its potential. In this study, PPMI will provide a comprehensive overview of initiatives aimed at addressing the real-world evidence (RWE) needs of stakeholders involved in research, clinical development of health technologies, regulatory decision-making, health technology assessment, policy decision-making, and clinical decision-making; take stock of the available outputs from EU-funded research initiatives and the most relevant non-EU funded research projects on the use of RWD; identify future research making RWD more valuable, and derive recommendations for the use of RWD to all concerned stakeholder groups. To achieve these goals, PPMI team will carry out an extensive desk research, identify and map RWD projects, conduct surveys, interviews and case studies in addition to cluster analysis, in-depth content analysis, network analysis, needs-gap analysis, and organising workshops.

This one-year study will be completed in cooperation with Maastricht University.

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