PROBLEM STATEMENT: Regulators and pharmaceutical and medical device manufacturers acknowledge the role patient-preference research can play in patient-focused drug development (PFDD). The growing recognition of the value of equity, diversity, inclusion, and belonging (EDIB) initiatives has challenged stakeholders to identify opportunities to promote diverse healthcare perspectives from underserved populations. Applying EDIB principles to the collection, interpretation, and use of patient preference information (PPI) in PFDD can support more inclusive and equitable health outcomes. This case study will discuss the ways PPI advances EDIB in PFDD as well as the challenges.
DESCRIPTION: PPI research systematically presents patient perspectives to regulators and industry to inform PFDD. This case study identifies 3 ways preference research can and is addressing diversity and representation in PFDD to ensure that PPI and PFDD processes and outcomes are inclusive. 1. At the study design phase, promote diversity among study teams by including preference researchers, patient scientists, clinical experts, and/or healthcare providers to ensure the study design, execution, and interpretation of preference research considers diverse perspectives and underrepresented stakeholders. 2. Recruit more inclusive study samples for research studies to ensure that PPI characterizes the perspectives of a diverse group. Include recent empirical studies of preference heterogeneity to highlight insights that may be gained from more diverse samples as well as the challenges in recruiting them. 3. Use inclusive language in data collection tools and medical writing to help respondents and decision-makers feel validated and make data more accurate and robust.
LESSONS LEARNED: We identified and discussed areas to advance EDIB principles in patient preference study design to ensure PFDD addresses the needs of a more diverse constituency and yields more equitable health outcomes. This case study also discusses the challenges of diversifying research teams and samples.
