The FHI Clinical project team supported site monitoring, site management and project management to assist the University of Notre Dame investigators achieve a level of rigor not typically required for a non-medical product in their double-blinded, randomized-cluster, placebo-controlled clinical trial of a spatial repellent against mosquitoes for malaria prevention.
Targeted geographic areas for the development of an antimalarial drug by Novartis included malaria-endemic regions in Africa and Asia, and Novartis requested assistance identifying and assessing potential clinical sites for their planned clinical trial. Our team conducted 38 rapid, in-depth, 2.5-day site feasibility assessments in the 18 countries.
Data monitoring strategies implemented by our bilingual CRA helped eliminate the backlog to ensure timely database lock in a phase 2 trial for Sanaria's innovative PfSPZ Vaccine for malaria in Equatorial Guinea, an area with limited prior research experience.
In a study conducted at 17 sites spanning nine countries in a Zika endemic region of the Americas and Caribbean, timely staffing of contract research associates (CRAs) was enabled by the project team’s network of bilingual resources and knowledge of local hiring practices.
The study team maintained a 91% retention rate in a study of a Chikungunya virus (CHIKV) vaccine, despite study disruptions due to natural disasters, including Hurricane Maria, and political unrest near the sites in five Caribbean countries in a CHIKV endemic region.
Within a challenging, resource-limited setting, the project team succeeded in reaching FP/FV six weeks after arrival in Sierra Leone and 99.998% accuracy of the planned-to-execute budget.
To help address the high global TB incidence and related death rate, the China TB Clinical Trials Consortium (CTCTC) was established by government and industry partners to help build clinical research capacity in China, which has a particularly high tuberculosis incidence.
In a Phase 3 study with a lengthy intervention for colorectal cancer, the project team reached a 70% retention rate, with steadily increasing enrollment rates, by implementing strategies to address poor patient enrollment and retention.