Patient preference studies
A patient preference study is designed to collect and analyze which therapy attributes matter to a patient community, how much these matter to patient communities, and the trade-offs a patient community is willing to make between therapy attributes. Patient preference studies are also known as patient-centered benefit-risk studies. In other words, what risks (such as adverse events) or inconveniences (such as a therapy needing to be given in a hospital weekly) is a patient will to accept for a specific benefit.
The U.S. Food and Drug Administration (FDA) and many regulatory agencies in other countries/regions recognize the value of the information provided by patient preference studies at many points along the therapy development pathway, but especially when it can be challenging to assess the benefits and risks on a therapy being reviewed for marketing approval.
Design, Conduct, and Use of Patient Preference Studies in the Medical Product Life Cycle: A Multi-Method Study [2019 published article]
U.S. Food and Drug Administration (FDA): Patient Preference-Sensitive Areas – Using Patient Preference Information in Medical Device Evaluation
NCATS Toolkit for Patient-Focused Therapy Development: Perform Patient Preference Studies
U.S. Food and Drug Administration (FDA): Advances in Patient Preference Information to Enhance Benefit-Risk Assessment: Learning from Case Studies [webcast, 2019]