Patient Preference Workshop

Advancing Use of Patient Preference Information as Scientific Evidence in Medical Product Evaluation

Thursday, Dec 7 (Day 1): 8:30 a.m. – 5:00 p.m. (Registration begins at 7:30 am)
Friday, Dec 8 (Day 2): 8:00 a.m. – 1:00 p.m. (Registration begins at 7:00 am)

Tommy Douglas Conference Center (TDCC)
10000 New Hampshire Ave, Building 9
Silver Spring, MD 20903

 

Hosted by Johns Hopkins, University of Maryland, UCSF-Stanford, Yale-Mayo Clinic, and the Georgetown University Center of Excellence in Regulatory Science and Innovation and the U.S. Food and Drug Administration [Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and the Office of Chief Scientist, Office of Regulatory Science and Innovation].

 

About the Workshop

Patients have unique perspectives about the value of the potential benefits and the impact of potential harms and burdens of their medical treatments. Scientists, clinicians, medical product developers, and regulators play critical roles in evaluating the benefits and risks of medical products. However, only patients live with their medical conditions and make choices regarding their own care. Reliable and accurate methods are needed in order to effectively incorporate patients’ values into decision-making processes.

Patient preference information is qualitative input or quantitative data elicited from patients about the desirability or acceptability of outcomes or other attributes of medical products, focusing particularly on trade-offs. The continued development of methods to elicit patient preference information and enhance its regulatory applications has the potential to contribute to a better understanding of the benefit-risk profiles of some medical products.

This workshop will:

  • Present current progress on incorporating patient preference information into medical product benefit-risk assessments
  • Provide examples of how patient preference can be collected, analyzed, and presented in a way that matters to stakeholders
  • Explore methods for appropriate measurement, interpretation, and adoption of patient preference information in a regulatory context
  • Identify future research and capacity needs in order to improve the use of patient preference information in a regulatory context

 

Registration Information

This workshop is free and open to the public. The intended audience includes patient groups, academia, industry, government, medical product policy makers, physicians, and the general public. This public workshop will be available to view via live webcast and will also be recorded for later viewing.

Please use the links below to register to attend in person or by webinar for each day of the two-day workshop (to attend the full workshop, you must register for Day 1 and Day 2 separately):

Register for Thursday, Dec. 7, 2017 (Day 1)
Register for Friday, Dec. 8, 2017 (Day 2)

Additional information on lodging options, transportation and accessibility information can be found here.

 

Draft Workshop Agenda

Day 1: Thursday, December 7, 2017

Time

Topic

8:30 am

Welcome

8:45 am

Session 1: Fundamental Concepts and Regulatory Context of PPI to Support Medical Product Development and Evaluation
Chair: Anindita Saha (FDA/CDRH)

Presentations
FDA’s Perspective: History and Context
The Academic Perspective on Patient Preference Research
Industry Perspective on PPI to Support Medical Product Development and Evaluation
Patient Perspective on PPI Landscape

Panel Discussion and Q&A

10:15 am

Break

10:30 am

Session 2: Scientific Fundamentals of PPI Studies
Chair: Martin Ho (FDA/CDRH) and Leslie Wilson (UCSF)

Presentation: Scientific Fundamentals of PPI Studies

Panel Discussions and Q&A

12:15 pm

Lunch

 

Session 3: In Depth Case Studies
Chair: Telba Irony (FDA/CBER) and Michelle Campbell (FDA/CDER)

1:15 pm

Case Study 1: Neurodegenerative disease

2:45 pm

Break

3:00 pm

Case Study 2: Pediatric Cancer/Rare Disease

4:25 pm

Patient Group Success in Patient Preferences

4:45 pm

Day 1 Closing Remarks

 

Day 2: Friday, December 8, 2017

Time Topic

8:30 am

Day 2 Welcome and Remarks

8:45 am

Session 4: CDRH Preference Sensitive Areas Discussion
Chair: Heather Benz (FDA/CDRH)

10:00 am

Break

10:15 am

Session 5: Capacity Building and Sustainability
Chair: Michelle Tarver (FDA/CDRH) and Fadia Shaya (UMD)

Presentations

Panel Discussion and Q&A

12:30 pm

CERSI Success in PPI

12:45 pm

Day 2 Closing Remarks

 

Contact Information

For questions please contact: [email protected].