Download eBook for Free

FormatFile SizeNotes
PDF file 1.4 MB

Use Adobe Acrobat Reader version 10 or higher for the best experience.

Real-world data (RWD) is an umbrella term for different types of data that are not collected in conventional randomised controlled trials. RWD in the healthcare sector comes from various sources and includes patient data, data from clinicians, hospital data, data from payers and social data. 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.

Based on a literature review, case studies, a small set of interviews of experts from public and private organisations and a scenario based workshop, the study outlined possible strategies to illustrate how RWD standards development could facilitate RWD-based research. By investigating the current forms and uses of RWD in Europe, this study has highlighted their significant potential for assessing the (short- or long-term) impact of different drugs or medical treatments and for informing and improving healthcare service delivery. Although the potential of RWD use seems quite clear, this research reveals barriers that restrict further development towards its full exploitation:

  • the absence of common standards for defining the content and quality of RWD
  • methodological barriers that may limit the potential benefits of RWD analysis
  • governance issues underlying the absence of standards for collaboration between stakeholders
  • privacy concerns and binding data protection legislation which can be seen to restrict access and use of data.

Table of Contents

  • Chapter One

    Introduction: The rise of RWD in health and healthcare research

  • Chapter Two

    Moving from data to evidence: the state of RWD in Europe

  • Chapter Three

    Overcoming existing barriers through the development of standards to improve access to and use of RWD

  • Chapter Four

    Conclusion

  • Annex A

    Research approach

  • Annex B

    Literature review: search strategy and extraction tables

  • Annex C

    Case studies

  • Annex D

    Interviews

  • Annex E

    Scenarios

Research conducted by

The research described in this report was prepared for Pfizer Pharmaceuticals Ltd. and conducted by RAND Europe.

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.

Permission is given to duplicate this electronic document for personal use only, as long as it is unaltered and complete. Copies may not be duplicated for commercial purposes. Unauthorized posting of RAND PDFs to a non-RAND Web site is prohibited. RAND PDFs are protected under copyright law. For information on reprint and linking permissions, please visit the RAND Permissions page.

The RAND Corporation is a nonprofit institution that helps improve policy and decisionmaking through research and analysis. RAND's publications do not necessarily reflect the opinions of its research clients and sponsors.