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The Need for Real-World Evidence in Medical Product Development and Future Directions

In: Real-World Evidence in Medical Product Development

Author

Listed:
  • Weili He

    (Medical Affairs and Health Technology Assessment Statistics, Data and Statistical Sciences, AbbVie)

  • Yixin Fang

    (Medical Affairs and Health Technology Assessment Statistics, Data and Statistical Sciences, AbbVie)

  • Hongwei Wang

    (Medical Affairs and Health Technology Assessment Statistics, Data and Statistical Sciences, AbbVie)

  • Charles Lee

    (CVRM Regulatory Affairs, AstraZeneca)

Abstract

The organic and evolving nature of real-world Data (RWD) and real-world evidence (RWE) responding to the need of establishing RWE and the fit-for-purpose requirements for expanding applications of RWE to address payers, patients, physicians’ need along with supporting regulatory decisions is a defining characteristic of this arena. This chapter will introduce RWD and RWE definitions and discuss the need for the use of RWD in the various stages of drug development, given the increasing uptake of RWE across regulatory, industry, and academia globally. Great progresses have been made in the last few years in this field, which we will review and summarize. Further, we will provide our thoughts on the further opportunities to address continued challenges and future directions.

Suggested Citation

  • Weili He & Yixin Fang & Hongwei Wang & Charles Lee, 2023. "The Need for Real-World Evidence in Medical Product Development and Future Directions," Springer Books, in: Weili He & Yixin Fang & Hongwei Wang (ed.), Real-World Evidence in Medical Product Development, pages 3-16, Springer.
    • Handle: RePEc:spr:sprchp:978-3-031-26328-6_1
    DOI: 10.1007/978-3-031-26328-6_1
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