Patient Preference Study Design Guide – Qualitative Steps: First steps for sponsors initiating a patient preference study

Apr 1, 2016Clinical, Discovery & Ideation, Invention & Prototyping, Patient-Centered Benefit-Risk (PCBR), Pre-Clinical

Patient Introduction

This study design guide provides an outline of the qualitative steps for initiating a patient preference study. The guide only includes qualitative steps used to develop the preference survey and does not include the development of the preference study protocol or statistical analysis plan. As the medical device industry moves toward advancing clinical studies that better reflect the needs and preferences of patients, it is important for patients to understand how they can partner in these efforts. Patients can use this material to understand what patient preference surveys are, how they are developed, and how they can be used by medical device sponsors.


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.