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IQVIA Consumer Health, ObvioHealth and Jovie USA Launch Innovative At-Home Trial to Bring First Goat Milk-Based Infant Formula to the US
The fully decentralized clinical trial was designed by IQVIA Consumer Health, ObvioHealth and Jovie USA, with guidance from the FDA, which is anticipated to fast-track approval for Jovie USA's goat milk-based formula.
Mar 29, 2023
IQVIA Consumer Health, in partnership with ObvioHealth, has launched a fully decentralized clinical trial with Jovie USA to bring the first FDA-approved goat milk-based infant formula to the United States. The innovative study design is the first of its kind for infant formula, allowing parents and their newborns to participate in the trial from their homes without the need for in-clinic visits.
Designed in collaboration with the FDA to increase the probability of regulatory success upon the completion of the trial, the study will evaluate whether babies fed Jovie’s goat milk-based formula show similar growth to babies who are fed cow milk-based formula or breast milk, the CDC’s growth standard.
To enable at-home participation, those taking part receive a scale and measuring devices and are trained during video calls by pediatric nurses on how to take the vital measurements essential to tracking healthy newborn growth. Nurses provide close oversight during measurements to ensure all is done correctly. The caregivers then use ObvioHealth’s app to report weekly measurements throughout the duration of the study.
The COACH (Clinical Oversight and Coordination Hub) team provides end-to-end, personalized assistance to caregivers via in-app messaging, phone, or video calls and remotely monitors trial data to ensure patient safety. The DCT platform is programmed to alert the COACH team of potential adverse events, such as an infant’s growth falling below the CDC threshold.
“Decentralized trials have been in high demand, yet their application in studies involving newborns has been notably limited thus far,” pointed out Dr Volker Spitzer, Vice-President, Global R&D/RWE Services, IQVIA Consumer Health. “Our collaboration with Jovie and ObvioHealth demonstrates the potential of such an innovative approach in accessing challenging-to-engage infant populations and their caregivers. We are thrilled to contribute to this initiative, which simplifies substantially parental involvement and eliminating the need for inconvenient clinic visits.”
In the U.S., four companies control approximately 90 percent of the infant formula market, an issue highlighted in 2022 at the peak of the U.S.’s formula shortage. Few other options are available to U.S. parents. Globally, goat milk infant formula is widely accepted, appreciated for its easier digestibility and nutrient absorption, and proven in clinical trials to be as safe and effective as cow milk formula and breastmilk.
“Parents in the U.S. who can’t or don’t want to breastfeed deserve more options,” said Jan van Marwijk Kooij, CEO of Jovie USA. “We are excited to have the opportunity to bring the first goat milk-based infant formula to the U.S. market, and we believe this trial will prove to regulators and parents alike that goat milk-based infant formula is an excellent choice.”
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