Leapcure Responds to FDA Guidance on Diversity in Clinical Trials

Key Insights

• Leapcure supports the FDA's Draft Guidance on Diversity Action Plans, aimed at promoting health equity and valid research results through inclusive clinical trial enrollment.
• Leapcure recommends categorizing trials based on patient-condition-study fit, offering flexibility in diversity requirements according to the trial's stage of development.
• The company suggests leveraging fast-track eligibility for trials that successfully meet diversity enrollment goals, incentivizing inclusive practices from the outset.

Leapcure has expressed its support for the U.S. Food and Drug Administration (FDA) Draft Guidance on Diversity Action Plans, which aims to increase diversity in clinical trials, aligning with the Food and Drug Omnibus Reform Act (FDORA). The company believes this initiative is a crucial step toward achieving health equity and ensuring the validity and generalizability of medical research outcomes.

Leapcure's Recommendations for Enhancing Diversity

Zach Gobst, Leapcure's CEO, stated, "At Leapcure, we believe in EQuitable clinical trials; elevating the patient voice, empowering advocacy groups, and improving life science research with empathy, compassion, and technology to research progress effectively." Leapcure's response to the FDA guidance focuses on integrating incentives and education, fast-tracking diverse trial data, and ensuring cultural competence in trial design.

Leapcure offers several recommendations to improve clinical research outcomes:

• Categorizing Trials Based on Patient-Condition-Study Fit and Adoption Stage: Leapcure suggests the FDA consider flexible diversity requirements based on a trial's maturity, allowing early-stage innovations to gather essential data while later-stage trials prioritize inclusive design.
• Leveraging Fast-Track Eligibility for Diversity Success: The company proposes that trials achieving diverse enrollment goals should benefit from fast-track review, similar to the approach used in rare disease research, to encourage inclusive practices from the beginning.
• Enhancing Cultural Competency in Trial Execution: Leapcure emphasizes the importance of cultural sensitivity and empathy when working with underrepresented communities to build trust, maintain participant engagement, and generate meaningful, high-quality data.

A Holistic Framework for Equitable Clinical Research

Leapcure advocates for a holistic framework that values diversity-focused design, rewards inclusive data, and emphasizes cultural competency. The company believes that implementing such a framework will not only strengthen the FDA's objectives but also drive equitable and effective clinical research for the future of healthcare.