USFDA's Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) released a draft guidance "Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle" to communicate when and what methods could be used to collect and submit patient preference information (PPI) across the total product life cycle. This will help integrate voluntary patient preference information (PPI) into decision-making processes over the lifecycle of medical devices and biologics.
The guidance is primarily intended for device manufacturers and biologics developers, aiming to encourage them to consider and include PPI throughout the Total Product Life Cycle (TPLC), from development to post-market surveillance.
The term "patient experience data" is used to describe data that provide information about the experiences of patients with a disease or condition; FDA encourages the development and evaluation of devices that consider patient experience data, including patient preferences regarding outcomes and treatments. The focus of this guidance is on patient preference information (PPI).
Patient preference information is defined as qualitative or quantitative assessments of the relative desirability or acceptability to patients of specified alternatives or choices among outcomes or other attributes that differ among alternative health interventions.
This guidance provides recommendations on how voluntary PPI may be considered by FDA staff in decision-making and the objectives of this guidance are:
to encourage submission of PPI, if available, by sponsors or other interested parties to FDA and to aid in FDA decision-making
to outline recommended qualities of patient preference studies, which may result in valid scientific evidence,
to provide practical recommendations for collecting and submitting PPI to FDA; and
to discuss FDA’s inclusion of PPI in its decision summaries and provide recommendations for the inclusion of such information in device labeling.
PPI may be particularly useful in evaluating a device’s benefit-risk profile when patient decisions are preference-sensitive. Patient decisions regarding diagnostic or treatment options are considered preference-sensitive when:
1. Multiple options exist, and none is clearly superior for all patients.
2. The evidence supporting one option over others is uncertain or varies by patient population.
3. Patients’ views on the benefits and acceptable risks differ, sometimes significantly, from those of healthcare professionals.
Patient Preference Information (PPI) can assist FDA’s benefit-risk assessment by:
1. Identifying key benefits and risks from a patient's perspective.
2. Assessing the relative importance of benefits and risks to patients and how they weigh trade-offs.
3. Understanding variability in patient preferences, especially for subgroups.
Manufacturers are encouraged to consult with the FDA when designing PPI studies and share their results. This collaboration helps ensure that studies align with regulatory expectations.
For more detailed information on Including patient input in FDA decision-making, Recommendations and Practical Considerations for Patient Preference Studies, etc refer to the official USFDA guidance documents:
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