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Written by Arathi Sethumadhavan


This guidance was issued by the FDA last month and provides answers to the following:

What is Patient Preference Information (PPI)?

  • Refers to patients’ experiences with a disease or condition and its management
  • Can also include the assessments of care partners
  • Can be quantitative or qualitative


What will PPI be used for?

  • PPI may be used to understand a disease and the impact it has on patients
  • PPI may be used to understand the risk-benefit tradeoffs for treatment from the patient’s viewpoint. Specifically, if a large number of well-informed patients believe that the benefits of the product far outweigh the risks, FDA can use this information to influence their decision
  • PPI may be used to understand how different sub-groups of the patient population view a product
  • PPI will be useful for devices with a direct patient interface, devices with an impact on patient’s quality of life, life-saving devices with a high risk profile, devices developed to treat a rare condition or novel devices
  • PPI may be used by the FDA to make decisions related to pre-market applications, humanitarian device exemptions, and de novo requests
  • FDA encourages the submission of PPI with sponsors’ device summaries and device labeling to help with their decision-making; however, the submission of PPI is not


What creates a good PPI study?

  • A study that involves a representative sample of well-informed patients of adequate size
  • A study that captures the heterogeneity of patients
  • A study design that effectively communicates benefits, harms, risks, and uncertainties associated with various health outcomes
  • A study design that minimizes cognitive biases
  • A valid and reliable study with robust data analysis

This guidance will be effective as of October 23, 2016.


How can Core help?

With a team of professionals with strong backgrounds in experimental psychology, statistics, cognition, and behavioral economics, Core has the expertise to conduct well-designed, robust studies that can help you collect the PPI that will help you create a strong, regulatory submission package.