Patient Preference
What is Patient Preference Information (PPI)?
Per the FDA:
“PPI is defined as qualitative or quantitative assessment of the relative desirability or acceptability to patients of specified alternatives or choices among outcomes or other attributes that differ among alternative health interventions.”
We are building a patient preference database
The Attribute Library is a searchable database and taxonomy designed to help researchers find, reuse, and adapt attributes for health preference studies. It streamlines study design and supports more consistent, patient-centered research.
Uses of PPI Across the TPLC
Early Development
⇒ Identify unmet medical needIdentify unmet medical need
⇒ Understand what matters most to patients about their disease or treatment
Clinical Trial Design
⇒ Inform endpoint selection
⇒ Inform performance goal
⇒ Inform effect size
Premarket Benefit-Risk Assessment
⇒ Analysis of condition
⇒ Current treatment options
⇒ Patient perspective on benefit-risk tradeoffs
⇒ Population subgroup considerations
Post-Market
⇒ Inform interpretation of new data affecting benefit-risk assessment
⇒ Inform studies of new/expanded use populations
⇒ Communicate benefit-risk information to patients
Patient Preference 101
Learn about the in’s and out’s of patient preference from PPI experts Juan Marcos Gonzalez (Duke Clinical Research Institute) and Barry Liden (University of Southern California Schaeffer Center).
FDA PPI Homepage
Learn more about how Patient Preference Information (PPI) is used by the FDA and The Center for Devices and Radiological Health (CDRH) in Medical Device decision making.
Still want to learn more?
Explore the following list of PPI and Patient Preference resources:
FDA PPI Guidance: 2016
Patient Preference Information – Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling
FDA Draft PPI Guidance: 2024
Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle
Consult the list of Patient Preference Consultants and Experts
Review MDIC’s compiled list of Patient Preference Consultants, Experts, and designated organizations of interest for Patient Preference Research.
FAQ's and Common Areas of Interest
Visit MDIC’s consolidated FAQ list and compiled areas of interest resource for further information
SPI Resource Library
Consult the host of available resources from the Science of Patient Input (SPI) program.
Resources:
Using Patient Preference Information in the Design of Clinical Trials Framework
The Medical Device Innovation Consortium (MDIC) has released a patient-centered framework developed to help researchers interested in conducting rigorous patient preference studies for medical device design, development, evaluation, and regulatory submissions.
Using Patient Preference Information in the Design of Clinical Trials outlines a systematic approach for patient-focused clinical trial design to better meet patient needs and priorities.
Patient Centered Benefit-Risk (PCBR) Framework
The PCBR Framework is intended to improve the understanding of the medical device community of how the patient’s perspective might be incorporated into the regulatory submission process.
This framework provides background on the concepts of benefit-risk and patient preference, discusses the potential value of including benefit-risk in a regulatory submission, discusses when in the product lifecycle such information might be collected, outlines factors to consider when selecting a patient preference method, and discusses considerations regarding the use of patient preference information in the regulatory submission process, reimbursement, marketing, and shared medical decision making.
Science of Patient Input (SPI) Program
Check out the SPI Home to learn more about SPI projects, initiatives, news, upcoming events.