What Is Patient Experience Data? The Regulatory Perspective

Defining Patient Experience Data in Light of the US 21st Century Cures Act

Baltimore, MD, USA—May 21, 2018—ISPOR, the professional society for health economics and outcomes research, held a session, “What Is Patient Experience Data? The Regulatory Perspective [W2],” this morning at ISPOR 2018 in Baltimore, MD, USA. This session was led by speakers from a variety of divisions at the US Food and Drug Administration (FDA) in Sliver Spring, MD, USA:

  • Martin Ho, MS, Center for Devices and Radiological Health (CDRH)
  • Megan Moncur, MS, Center for Biologics Evaluation and Research (CBER)
  • Pujita Vaidya, MPH, Office of Strategic Programs/Office of Program and Strategic Analysis, Center for Drug Evaluation and Research (CDER)

Over the past 5 years, the US FDA has made strides toward incorporating the “patient voice” in medical product decision-making. The Patient-Focused Drug Development and Patient Preference initiatives, begun under the FDA Safety and Innovation Act (FDASIA) of 2012, led to 24 public meetings held to learn from patients about their disease experience and to produce a guidance document about patient preference information in medical device applications. The 21st Century Cures Act and other FDA initiatives have helped to solidify the objectives of these initiatives.

The speakers discussed current efforts to promote and advance the incorporation of patient input into the regulatory decision making processes. Providing examples of patient experience data and its application in medical product development, they identified opportunities for patient stakeholders to help strengthen capacity and advance fit-for-purpose methods and tools.

Additional information on ISPOR 2018 can be found here. Released presentations from the conference can be found here. Interested parties can follow news and developments from the conference on social media using the hashtag #ISPORBaltimore.



ISPOR, the professional society for health economics and outcomes research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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