> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Patient Preference Info Seen as Scientific Evidence
- URL: https://www.fdaweb.com/patient-preference-info-seen-as-scientific-evidence/
- Published: 2016-10-05T12:00:00.000Z
- Updated: 2026-09-14T21:37:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136997

CDRH evaluates submitted patient preference information as valid scientific evidence along with other evidence from clinical and non-clinical testing when making benefit/risk determinations, according to Office of Surveillance and Biometrics associate director for quantitative innovation **Martin Ho**. He was one of two Center presenters on a 9/27 [Webinar](http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm518783.htm?ref=fdaweb.com) on the agency’s final guidance on patient preference information. He indicated that the guidance does not change any review standards for safety or effectiveness. “The patient preference information evidence provides additional insights from patients for benefit/risk assessment,” he said. “The guidance provides recommendations regarding the voluntary collection of patient preference information that may be submitted for consideration as valid scientific evidence as part of FDA’s benefits assessment.”

He said the guidance lists 11 recommended qualities of preference studies, organized in three domains — all about patients, good study design, and good study conduct.

A second presenter, director of external expertise and partnerships in the Office of the Center Director **Annie Saha**, described the evolution of the role of patients, especially with so much information available on the Internet, and how that led to development of the guidance. One of the Center’s strategic priorities for 2016-17, she said, is to partner with patients and interact with them to advance development and evaluation of innovative medical devices. The two aspects of that priority, she said, are to promote a culture of meaningful patient engagement by facilitating interaction between Center staff and patients, and to transparently increase the use of patient input as evidence in decision-making.

For purposes of the guidance, Saha said, patient preference information is considered to be qualitative or quantitative assessments of the relative desirability or accessibility to patients of specified alternatives or choices among outcomes or other attributes that differ among alternative health interventions. “Patient preferences,” she said, “can really provide us with valuable information about what are the benefits and the risks that are most important to the affected patient population, what are the benefit/risk tradeoffs that are acceptable from a patient perspective. And are there relevant subgroups of patients that would really accept a particular benefit risk profile or choose a potential treatment option over other alternatives that exist.?”

Saha distinguished between patient-reported outcomes, which are a patient’s report on the status of a health condition before, during, or after therapy, and patient preference information, which looks at types of therapy or attributes of products that patients might prefer.