- September 30, 2020
10:00 AM - 4:00 PM ET
The U.S. Food and Drug Administration (FDA) is announcing a virtual public meeting entitled "Patient-Reported Outcomes (PROs) and Medical Device Evaluation: From Conception to Implementation". The purpose of this public meeting is to discuss the benefits and challenges of incorporating the patient perspective in regulatory decision making using patient-reported outcome (PRO) instruments.
The Center for Devices and Radiological Health (CDRH) at the FDA emphasizes the importance of including the patient voice during the design and evaluation of medical devices. The use of well-developed patient-reported outcome (PRO) instruments helps to accomplish this in a structured, well-defined, and reliable way. These instruments (also called tools) include questionnaires, diaries, and numeric rating scales used to collect information directly from the patient about their health status and are not subject to interpretation by a healthcare provider or outside observer. Increasingly, PRO instruments are being used in clinical care to help evaluate medical conditions, being integrated into clinical investigations, and of importance to payers and regulators.
The FDA invites the medical device industry, patient organizations, research organizations, healthcare professionals, and payers 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 PRO instruments, applications across the healthcare ecosystem, and potential efficient approaches.
This meeting will be held virtually on September 30, 2020 from 10:00 a.m. to 4:00 p.m. (EDT).
This agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.
|Incorporating PRO Instruments into the Healthcare Ecosystem|
|10:00 a.m.||Meeting Logistics and Welcome||Brittany Caldwell, PhD
William Maisel, MD, MPH
|10:15 a.m.||Importance of Patient-Reported Outcomes (PROs)||Paul Conway
Kendra Hileman, PhD
Fraser Bocell, PhD
Christina Webber, PhD
|11:00 a.m.||Incorporating a PRO Instrument Efficiently in the Healthcare Ecosystem||Ileana Piña, MD, MPH
Nelson Freimer, MD
Amy Cizik, PhD, MPH
Joseph Chin, MD
Kimberly Brown Smith, MD, PhD
|Identifying the Concept, Selecting the Instrument, and Preparing for Change|
|12:30 p.m.||Bridging PRO Instruments to Ensure Relevancy Across Demographics||Bram Zuckerman, MD
John Spertus, MD, MPH, FACC
Theresa Coles, PhD
Courtney Lyles, PhD
Christopher Almond, MD
Brittany Caldwell, PhD (Moderator)
|1:30 p.m.||Developing PRO Instruments When One Does Not Exist||Andrea Pusic, MD, MHS, FACS, FRCSC
Sung Yoon, MD, FACS
Ron Hays, PhD
Malvina Eydelman, MD
Katharine Barnard-Kelly, PhD, CPsychol, AFBPsS
Courtney Lias, PhD
Kathryn O'Callaghan (Moderator)
|Collaborating to Develop Solutions|
|2:45 p.m.||Multistakeholder Collaborations for Instrument Development||Pamela Goldberg
Matthew Roe, MD
Jennifer Flythe, MD, MPH
Amanda Grandinetti, MPH
Annie Saha (Moderator)
|3:45 p.m.||Future Horizons and Closing Message||Michelle Tarver, MD, PhD|
Registration is now closed.
If you require special accommodations due to a disability or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, Susan.Monahan@fda.hhs.gov.
For questions regarding meeting content please contact:
Michelle Tarver, MD, PhD
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
- Patient-Reported Outcomes (PROs) in Medical Device Decision Making
- Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (FDA Guidance)
- Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations (FDA Draft Guidance)
- Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (FDA Guidance)
|Patient-Reported Outcomes (PROs) - Introduction||pdf (722.39 KB)|
|Patient-Reported Outcomes (PROs) - Session 1||pdf (2.31 MB)|
|Patient-Reported Outcomes (PROs) - Session 2||pdf (1.20 MB)|
|Patient-Reported Outcomes (PROs) - Session 3||pdf (3.54 MB)|
|Patient-Reported Outcomes (PROs) - Session 4||pdf (4.15 MB)|
|Patient-Reported Outcomes (PROs) - Session 5||pdf (1.01 MB)|
|Patient-Reported Outcomes (PROs) - Transcript||pdf (695.84 KB)|