Patient preference has the potential to inform a host of issues from initial device or drug development to post-marketing surveillance. While patient preference studies in health care research are becoming common, their use in regulatory decision making is relatively new.
The recent passage of the FDA Reauthorization Act of 2017 (FDARA) will allow the FDA to continue to strengthen their ability to incorporate preference studies into regulatory decision making in meaningful ways.
In an editorial in this month’s The Patient, experts including Brett Hauber, PhD, VP of Health Preference Assessment at RTI Health Solutions, put forward the question, “What should the regulatory requirements be for these types of studies?”
The authors suggest that we must first understand the “unknowns” in patient preference studies. They list these as:
1. Validity and Reproducibility of Existing Methods
2. Effect of Method Choice on Study Results
3. Effect of Sample Composition on Study Results
4. Effect of Attribute Inclusion or Exclusion on Study Results
5. Effect of Communication Style and Methods on Study Results
They then propose “concrete, empirical studies,” to address each of these unknowns and call on researchers to “address the gaps and advance the science of patient preferences.”
Find the entire article here.