Pre-Conference Workshop Day
Tuesday | December 10, 2024
8:00 am Registration & Networking
09:00am-12:00pmWorkshop A
Advancing DE&I in Rare Disease Clinical Trials to Ensure Representative Enrolment
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
12:00 pm Lunch & Networking
01:00pm-04:00pmWorkshop B
Navigating Patient Reimbursements & Benefits to Ensure Fair Patient Compensation
Synopsis
As clinical trials become increasingly complex and costly, optimizing cost-efficiencies while ensuring fair patient compensation remains a significant challenge. This interactive workshop will dive into strategies for balancing budget constraints with effective patient reimbursement solutions. We’ll explore innovative approaches for reducing trial costs and enhancing recruitment and retention without compromising patient support. By examining real-world examples and engaging in collaborative discussions, we’ll work together to uncover actionable insights and practical solutions for streamlining trial processes and making patient compensation more flexible and impactful.
Highlights include:
- Exploring innovative alternatives to cash reimbursements, such as travel vouchers and in-kind support
- Strategies for ensuring fair compensation for patients without compromising trial budgets
- Discussing case studies of successful patient reimbursement programs