Advancing Use of Patient Preference Information as Scientific Evidence in Medical Product Evaluation
Thursday, December 7, 2017
8:30 a.m.-5:00 p.m.
Tommy Douglas Center, 10000 New Hampshire Ave., Silver Spring MD 20903
301 405 0285
When: December 7-8, 2017
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. – 4:00 p.m. (Registration begins at 7:00 am)
Where: Tommy Douglas Conference Center (TDCC), Building 9, at 10000 New Hampshire Ave, Silver Spring, MD 20903 (about 1 mile from the FDA White Oak, Silver Spring, Maryland campus)
Goals and Objectives:
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.
Who Should Attend:
This workshop is open to the public. The intended audience includes patient groups, academia, industry, government, medical product policy makers, physicians, and the general public.
Agenda, Accommodations, Directions, and Parking Information:
More information on accommodations, directions, food, and parking is available at these links: www.ucsfstanfordcersi.org/pp-workshop and https://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm574320.htm
Remote Access Information:
This public workshop will be available to view via webcast but pre-registration is still required. The workshop will be recorded for later viewing. The webcast link will be provided after you register for the workshop.
Registration for FDA and non-FDA Attendees:
There will be no registration fee to attend in-person or access the workshop via the webcast, but registration is required for each of the two days of the workshop.
To register to attend in person or by webinar go to these links for each day of the two-day workshop (to attend the full workshop, you must register for Day 1 and Day 2 separately):
Registration Link – Thursday, Dec. 7, 2017 (Day 1): https://collaboration.fda.gov/ocs_orsi_patient_preference/event/registration.html
Registration Link – Friday, Dec. 8, 2017 (Day 2): https://collaboration.fda.gov/ocs_orsi_patient_preference_d2/event/registration.html
Please provide the information requested for each attendee. Note: for those with past Adobe Connect accounts, you will be asked for your password, or to create a new password.
This event will be recorded and made available to the public after its conclusion. Any information shared publicly by participants during the event will become part of that recording. This includes the verbal question and answer sessions.
For Questions and Reasonable Accommodations:
For questions, please contact: FDA-CERSI-Collaborative-Workshop@fda.hhs.gov.
Americans with Disabilities Act
TDCC shall provide, to the extent required by the Act, such auxiliary aids and/or services as may be reasonably requested for use in sleeping rooms and public areas of the hotel, provided that reasonable advance written notice is provided to TDCC of such needs. If special accommodations at TDCC are needed due to a disability, please contact Jean-Pierre Gaster, Assistant General Manager, 240-645-4103 direct, or email: email@example.com, at least 7 days in advance of the workshop.