The Power Of Decentralized Clinical Trials In Accelerating Infant Formula Studies

By Betsy Reid

Infant formula is crucial for the nutrition and growth of babies in North America and Europe during their first year of life. Following the shutdown of the largest U.S. infant formula plant in February 2022, the country still faces supply issues. To address this, the FDA temporarily allows certain covered manufacturers to market non-compliant infant formulas if they take action for compliance. A New Infant Formula Submission is required by September 3, 2023, if a clinical study is needed.

To meet the submission deadline and bring new infant formulas to market, more sponsors are planning trials. However, enrollment poses challenges due to FDA requirements, hospital initiatives promoting breastfeeding, and parents' reluctance for site visits.

Explore the ways decentralized clinical trials are addressing enrollment study challenges and empowering sponsors and CROs to reach a broader geographical pool of eligible participants while alleviating the study burden on parents, thereby boosting enrollment rates and improving participant retention.