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Applications Using Real-World Evidence to Accelerate Medical Product Development

In: Real-World Evidence in Medical Product Development

Author

Listed:
  • Weili He

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

  • Tae Hyun Jung

    (Office of Biostatistics, CDER, Food and Drug Administration)

  • Hongwei Wang

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

  • Sai Dharmarajan

    (Office of Biostatistics, CDER, Food and Drug Administration)

Abstract

As the use of real-world evidence (RWE) and real-world data (RWD) continuously evolves, the strategic planning and tactical implementation is becoming multifaceted and should be considered with the real application setting in mind. In this chapter, we describe a few real examples that regulatory agencies considering the use of RWE/RWD for regulatory decisions. For each case study, where information is available in the public domain, we summarize the clinical and real-world (RW) study background and provide our analysis on following aspects: the regulatory contexts, whether the use of RWE/RWD is pivotal or supplemental for the regulatory decisions, the regulatory quality data sources, statistical methods employed, settings where the approvals were obtained or denied, and any regulatory opinions for the submission and regulatory decision. These useful case studies will provide important learning for future applications.

Suggested Citation

  • Weili He & Tae Hyun Jung & Hongwei Wang & Sai Dharmarajan, 2023. "Applications Using Real-World Evidence to Accelerate Medical Product Development," Springer Books, in: Weili He & Yixin Fang & Hongwei Wang (ed.), Real-World Evidence in Medical Product Development, pages 365-386, Springer.
    • Handle: RePEc:spr:sprchp:978-3-031-26328-6_19
    DOI: 10.1007/978-3-031-26328-6_19
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