PURPOSE: The FDA has released a priority list of patient-preference-sensitive areas, and preference studies are of increasing interest to regulatory authorities and payers globally. Current guidelines document the importance of qualitative research for DCEs but give no further guidance on the standards, methods or different applications of qualitative research in this context. The objective of this workshop is to propose and discuss standards and encourage systematic reporting of qualitative methods in DCEs; identify best practice and further the application of gold standard methods for qualitative approaches in DCEs.

DESCRIPTION: We will present a recent literature review showing that a large proportion of published DCEs do not report details on the qualitative methods used. In those that do, a great heterogeneity in methods and applications is noted. Examples of qualitative approaches and their challenges for DCEs will be presented and discussed. Shared experience will be used to define key learnings. The applicability of elements of PRO development standards to methods used for DCEs will be presented, with specific examples and case studies from both PRO and DCE studies. Finally, a list of standards necessary for qualitative research in DCEs, based on common experience will be discussed and drawn up. This workshop will give participants the opportunity to gain insight into necessary standards for qualitative research for DCEs, and how best practice guidelines could support these efforts. Discussion leaders will present in 2 20-minute sessions, with 2 10-minute audience interactive sessions.