Transitioning A Phase III Age-Related Macular Degeneration Clinical Trial

A large pharmaceutical company needed to transition their ongoing study after site selection was complete since the current vendor was not able to offer adequate site support. UBC implemented a transition plan and established strong relationships with the previously selected ophthalmology sites within 6 weeks.

Challenges presented themselves in multiple areas:

• Site Engagement & Communication

The ophthalmology sites were becoming disengaged because of minimal program communication and delayed or missed payments.

• Patient Barriers to Involvement

This study involves older, ocularly impaired patients so transportation to the investigational site can be difficult.

• Global Public Health Crisis

The study was already fully launched nationwide when the global health crisis resulted in mandated site closures and implementation of social distancing measures.

UBC quickly implemented effective actions to ensure clinical trial continuity and maximize efforts in data collection. UBC executed an efficient study transition while simultaneously accelerating the trajectory of site activation and patient enrollment.