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.
One example of the ability of public-private partnerships to establish and strengthen research capacity is the Equatorial Guinea Malaria Initiative (EGMVI), which began within the larger Bioko Island Malaria Control Project (BIMCP). Last year, the two were combined into the Bioko Island Malaria Elimination Project (BIMEP). Dr Stephen Hoffman from Sanaria, Inc. shared details of the BIMEP with us. FHI Clinical has also had the privilege of being involved in studies conducted by the EGMVI (now BIMEP).
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.