(EA01-05-26) Equity in Enrollment: A 20-Year Review of Diversity in Infant Nutrition Clinical Trials and Alignment With FDA Expectations

Name of the scientific conference where the work was recently presented: American Society for Parenteral and Enteral Nutrition (ASPEN) 2026 Annual Conference at Long Beach, California

Date on which the work was previously presented at the scientific conference listed above: February 14-17, 2026

Objectives: The U.S. Food and Drug Administration (FDA) has emphasized the importance of diversity in clinical trials, urging sponsors to ensure study populations reflect the demographics of those who will ultimately use the product. This guidance is particularly critical in the field of pediatric nutrition, where infant formulas serve a broad and diverse population of infants, including those born preterm or with specific dietary needs, such as cow's milk allergy. Ensuring demographic representation in clinical research not only supports regulatory compliance but also enhances the generalizability and ethical integrity of the findings.

Methods: To assess the alignment with this expectation, we conducted a retrospective review of Mead Johnson Nutrition–sponsored clinical trials in the U.S. over the past 22 years (2002 to 2024). This review focused on pediatric nutrition studies involving routine infant formulas (14 studies), hypoallergenic infant formulas (3 studies), and formulations designed for preterm infants (3 studies). Participant race data were compared with real-world estimates, which were derived from national birth statistics using a Bayesian approach.

Results: For routine infant formula, real-world estimates comprised of 77% White, 17% Black, and 6% Other, and the studies represented 79% White, 15% Black, and 6% Other. For hypoallergenic formulas, real-world estimates were 83% White, 7% Black, 10% Other, compared with 84% White, 10% Black, 6% Other in the clinical trials. For preterm studies, real-world estimates were 67% White, 22% Black, and 11% Other, and the studies included 66% White, 26% Black, and 8% Other.

Conclusions: These results demonstrate that these clinical trials reflect the racial composition of intended users and that recruitment strategies have effectively reached populations aligned with real-world estimates. It is critical to recognize the importance of further enhancing inclusivity in clinical research and strive to broaden representation of additional racial and ethnic groups in future pediatric nutrition studies. These insights will inform future trial planning and help ensure nutritional products are safe and effective for all infants.

Funding Sources: Mead Johnson Nutrition