Site Monitoring & Management in a Clinical Trial of a Spatial Repellent for Vector-Borne Disease Control

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.

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Rapid Site Assessment and Recommendations for Clinical Trials of a New Malaria Treatment

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.

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Providing Site Monitoring and Management Expertise in Malaria Vaccine Trials in Equatorial Guinea

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.

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Phase II/IIb Trial of a Zika Vaccine Spanning Nine Countries

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.

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Clinical Research Training to Support Capacity Building in Liberia

To equip Liberia with the ability to respond to ongoing health issues and potential outbreaks, a US government contract provided funding to train local leaders in Liberia’s clinical research infrastructure network. The training aimed to build a solid foundation to conduct international quality clinical research.

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Phase II Trial of a Chikungunya Vaccine in the Caribbean

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.

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Building Capacity for Tuberculosis Research in China: The China TB Clinical Trials Consortium (CTCTC)

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.

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