ObvioHealth—a leading virtual research organisation (VRO)—in collaboration with IQVIA Consumer Health has reportedly rolled out a decentralised clinical trial with Jovie USA to help commercialise its goat milk-based infant formula in the USA.
If approved, Jovie will be the first in the country to bring FDA-certified goat milk-based infant formula to the USA, reported CISION PR News.
The partnership is aimed at facilitating the roll-out of the controlled and fully remote clinical trial designed in accordance with the guidance of the FDA.
“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, ” said Jan van Marwijk Kooij, CEO of Jovie USA.
Even though goat milk has long been considered a good protein source in infant formula in Europe and other parts of the world, no goat milk-based infant formula is yet available in the USA.
That said, Food and Drug Administration has mandated all new infant formulas go through a rigorous growth monitoring study before being commercially available.
Certified according to European infant formula standards, Jovie claims that all nutrients contained in its goat milk-based infant formula comply with FDA infant formula requirements.
The DCT study is aimed at assessing if Jovie’s goat milk-based formula meets CDC’s growth standard and whether the infants fed this organic goat milk-based formula exhibit identical growth rates to those who are fed breast milk or commercially available cow milk-based formula.
The in-home study jointly conducted by ObvioHealth, Jovie, and IQVIA is said to meet DCT regulations and guidelines issued by FDA. The study process is reviewed by an independent institutional review board (IRB) and complies with all ethical provisions delineated by the designated IRB.
Expectant mothers (35 weeks or more) and those with kids younger than 12 days are urged to participate in the study. Babies who are exclusively breastfed can also participate in the DCT.
Participants are provided with all required devices and live video training on the appropriate process of formula preparation and measuring and tracking newborn growth.
Measurements taken and entered by the participants are monitored by dedicated caregivers for at least two consecutive follow-up measurements.
ObvioHealth’s DCT app is used by caregivers to efficiently submit weekly reports on the measurements taken by the participants.
To ensure patient safety while remotely monitoring trial data, the expert COACH (Clinical Oversight and Coordination Hub) team at ObvioHealth offers personalised end-to-end supervision to caregivers over the phone or via video calls and in-app messaging.
“Our partnership with Jovie illustrates how decentralised studies can reach hard-to-recruit newborn populations and their parents,” said Ivan Jarry, CEO of ObvioHealth. “We’re very excited to be a part of this effort to make it easier for parents to participate in such a trial, with training and support from expert clinicians and without having to make burdensome visits to clinics.”
That said, even though decentralised clinical trial models are fast gaining momentum, DCTs on paediatric research have notably been limited thus far.
The DCT conducted on Jovie’s organic goat milk-based infant formula is expected to offer CROs an effective avenue for mitigating the issues that typify paediatric research, such as participant enrollment, retention, and patient-reported data accuracy.
“Our collaboration with Jovie and ObvioHealth demonstrates the potential of the DCT approach in accessing difficult-to-engage infant populations and their caregivers, ” explained Dr. Volker Spitzer, Vice-President, Global R&D/RWE Services, IQVIA Consumer Health. “We are thrilled to contribute to this initiative, which simplifies substantially parental involvement and eliminates the need for inconvenient clinic visits.”
The study needs up to 18 weeks and includes participant recruitment and live training. A compensation of $590 spread out over eight payments is declared for the participants contributing to this study.
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