Patient Preference Study Design Guide – Qualitative Steps: First steps for sponsors initiating a patient preference study
This guide provides an overview of the qualitative steps used to develop the patient preference survey. The MDIC report “A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology” and the CDRH Guidance on Patient Preference offer valuable information on the reasons and factors to consider when contemplating the development of a patient preference study to be submitted as part of a regulatory submission. However, the Framework does not outline how to get started. This guide intends to help with those first steps.