Decentralized clinical trial (DCT) approaches are helping sponsors overcome persistent enrollment and participation barriers, especially in pediatric nutrition studies with narrow eligibility windows and limited site availability.
This case study shows how Premier Research designed and executed the first predominantly decentralized infant formula trial, partnering with the FDA to align on study design and ultimately achieving “No Further Questions” (NFQ). The hybrid model improved recruitment, reduced caregiver burden, and supported high-quality data collection.
In This Case Study:
- How decentralized strategies helped address enrollment challenges in infant formula research
- Practical use of digital outreach, virtual sites, and home health support
- Retention and participant experience
- How the study achieved successful completion and FDA NFQ