We were honored to be part of the important discussion in a recent webinar from the African Academy of Sciences — “Strengthening the African clinical trials regulatory and ethics environment” — about extending research to areas where FHI 360/FHI Clinical has worked for decades. Participants included representatives of the AAS, Bill & Melinda Gates Foundation, World Health Organization (WHO) Regional Office for Africa, Novartis and FHI Clinical.
Quality data are needed to ensure that vaccines and therapies in development are focused on the right targets and deliver the expected outcomes. In the midst of an outbreak, how do we ensure that we have access to patients at sites that are prepared to collect the high-quality data needed for regulatory approval?
During an outbreak, epidemiological data help us understand a disease: what, how much, when, where and among whom. With this information, we can analyze a health problem and provide timely information to support decisions for initiating or modifying control and prevention measures.