Update on Patient-Reported Outcome Instruments and Patient Preference Information

Today, the U.S. Food and Drug Administration (FDA) announced two virtual meetings about patient-reported outcomes (PRO) and patient preference information (PPI).

Upcoming Virtual Meetings

Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond. The FDA and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) invite stakeholders to join this meeting to explore the potential applications, challenges, and opportunities for using Patient Preference Information (PPI). Patients, caregivers, health care providers, payers, and regulated industry will discuss the importance of including PPI in different settings. Additionally, case studies highlighting the use of PPI and methodologies for collecting PPI will be presented.

Workshop Date: Tuesday, September 29, 2020
Location: Webcast
Registration: No fee for registration. Registration is required.

If you have questions, email CDRH-PPI@fda.hhs.gov

PPI Meeting Details

Patient-Reported Outcomes (PROs) and Medical Device Evaluation: From Conception to Implementation. The FDA invites stakeholders to join this discussion on approaches to incorporating PRO instruments in regulatory decision making. Important topics that will be discussed include considerations for modifying and adapting (“bridging”) PRO instruments, developing new PRO instruments, selecting the appropriate PRO instrument, and implementing PRO instruments in medical device clinical studies.

Workshop Date: Wednesday, September 30, 2020
Location: Webcast
Registration: No fee for registration. Registration is required.

If you have questions, email CDRH-PRO@fda.hhs.gov

PRO Meeting Details