PCR39 Patient and Caregiver Diversity in FDA Patient Engagement Activities and CBER-Regulated Therapeutics: A Review of the Literature

Abstract

This review of literature is aim one of a multipronged pilot project to understand what is known about current research and efforts related to increasing diverse patient engagement in drug development and factors that contribute to variances in knowledge of- and participation in- patient engagement activities relevant to U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) regulated products for food allergies. A two-fold approach was used to conduct this review: (1) a scoping systematic literature, and (2) a review of grey literature. Research abstracts were screened and reviewed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for articles published between years 2012-2021. All abstracts were screened by two trained researchers and reviewed by a third using predefined inclusion criteria. Grey literature was information identified from food allergy organization websites and screened for inclusion by two trained researchers following prespecified criteria. A Microsoft excel® tracking tool was built to organize extracted data. Finally, a framework developed by the National Health Council (NHC) was adapted and used to synthesize the extracted data for both approaches. Seven out of 1,370 research abstracts were included for full text data analysis. In most (86%), patients and caregivers were solely study participants, compared to one study (14%) in which they were actively involved in informing the research process. Sixteen organization websites were identified for screening—seven of which were included for analysis. 71.4% (5/7 organizations) reported engagement opportunities for patients/caregivers but did not explicitly share how diverse populations were encouraged to engage. The importance of diverse patient engagement in food allergy therapeutic development has been stressed by both patient organizations and in research. However, further exploration is needed in how to meaningfully engage diverse groups of patients and caregivers impacted by food allergies to help inform regulatory decision-making