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Perform Patient Preference Studies

Lead or Support

Patient preference studies can be performed by your group, other patient groups, industry, academia, and even the FDA, as is the case with Patient-Focused Drug Development (PFDD) Public Meetings. Depending on the timing and reasoning behind a patient preference study, it may be most helpful to form a collaboration. Remember that the objective of a patient preference study is to gain perspectives that are representative of the entire patient population, so working with other groups and reaching out to patients that may not belong to any group can increase the impact of the study. When you are deciding whether to perform the study alone, or take the lead or play a supporting role in a collaborative effort, you may wish to consider a number of factors.

  • Cost of performing a study:
    • Study costs may range from $100,000 to $400,000 and up.
  • Staff time needed for the duration of the study:
    • Studies may take from 6 to 9 months from start to finish.
  • Requirement of external expertise to design and analyze study:
    • Large industry partners may have expertise among their staff.
    • Academic partners can offer experience, scientific rigor, and credentials, as well as a knowledge within a specific disease area.
  • Outreach experience to include patients outside group membership.
  • Historical participation of membership in similar surveys.

Resources

Engage with the FDA
FDA Patient Affairs U. S. Food and Drug Administration (FDA) (link)
FDA For Patients Website U. S. Food and Drug Administration (FDA) (link)
Medical Device Innovation Consortium (MDIC) Patient Centered Benefit-Risk Project Report Medical Device Innovation Consortium (MDIC) (link)
FDA-led Patient-Focused Drug Development (PFDD) Public Meetings U. S. Food and Drug Administration (FDA) (link)
Enhancing Benefit-Risk Assessment in Regulatory Decision-Making U. S. Food and Drug Administration (FDA) (link)
Tips for Success
Key Considerations in Developing & Integrating Patient Perspectives in Drug Development: Examination of the Duchenne Case Study Biotechnology Innovation Organization (BIO) and Parent Project Muscular Dystrophy (PPMD) (link)
Benefit-Risk Boot Camp FasterCures (link)