Synopsis

Diversity, equity, and inclusion (DE&I) in clinical trials have become critical focal points for regulatory bodies and the broader industry, underscored by the enactment of Congress in late December 2022, mandating diversity action plans for clinical trials reviewed by the FDA for market approval. In this workshop, we will delve into strategies for overcoming these barriers and enhancing DE&I in rare disease clinical trials. We will draw insights from key industry players dedicated to broadening accessto clinical research for underserved populations affected by rare diseases. Join us as we work together to ensure that every patient, regardless of background, has the opportunity to participate in and benefit from clinical research.

Highlights include:

• Exploring the recent legislative requirements and FDA guidance regarding diversity action plans and Race and Ethnicity Diversity Plans for clinical trials

• Identifying and discussing the barriers that hinder diverse populations’ participation in rare disease clinical trials, including access to healthcare, advocacy support, regulatory barriers, and traditional clinical research models

• Presenting case studies from organizations that have successfully implemented strategies to improve DE&I in clinical trials

• Providing actionable strategies for drug development stakeholders to enhance DE&I in rare disease clinical trials, including outreach to diverse communities, culturally sensitive patient education, and community engagement