Driving Diversity and Inclusion in Cancer Drug Development - Industry and Regulatory Perspectives, Current Practices,...

Area of Science:

• Clinical Trial Design and Operations
• Health Equity and Inclusion
• Drug Development and Regulatory Science

Background:

• Historically, diversity, equity, and inclusion (DEI) have not been systematically integrated into early clinical trial design.
• A retrospective approach to DEI results in clinical trial populations not reflecting the diversity of patients who will use new therapies.
• This lack of diversity can lead to suboptimal benefits and risks for underrepresented patient groups.

Purpose of the Study:

• To outline strategies for improving diversity in clinical trials, as per FDA draft guidance.
• To advocate for a shift from retrospective to prospective, intentional DEI strategies throughout the drug development lifecycle.
• To highlight the importance of DEI for maximizing therapeutic benefits and minimizing risks across all patient populations.

Main Methods:

• Review of FDA draft guidance on improving diversity in clinical trials.
• Analysis of current sponsor practices and opportunities for enhancing DEI.
• Focus on four key areas: institutional commitment, clinical development strategy, enrollment goals, and operational strategy.

Main Results:

• Sponsors' current DEI efforts are being evaluated across institutional, strategic, and operational domains.
• Prospective DEI strategies require long-term engagement with diverse patients and communities.
• Shared learning and collaboration among stakeholders are essential for sustainable DEI adoption.

Conclusions:

• A prospective and intentional approach to DEI is necessary for equitable clinical trial outcomes.
• Prioritizing diverse population enrollment in study planning, design, and recruitment enhances drug development, particularly for oncology therapies.
• Implementing robust DEI strategies ensures equitable access to innovative therapies for all patients.