The industry’s response to outbreaks like COVID-19 will continue to push advances in technology and influence the way we conduct clinical research. Challenges we’ve faced trying to adhere to impossible timelines and budgets have solidified the need for a technology platform that includes three main characteristics: unified, modular and cloud-based.
In this third blog post in our ASTMH blog post series, we share information about Liberia’s efforts to recover from the Ebola outbreak, including information presented by Bernice Dahn, Vice President of College of Health Sciences at the University of Liberia, at FHI Clinical’s ASTMH dinner event.
Viruses don’t recognize borders, so it’s important that people and governments don’t either when communicating about an outbreak. Communication across countries, between private companies and government organizations, or between industries can accelerate rapid testing, manufacturing and development of diagnostics, vaccines and therapeutics.
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?
COVID-19 is a perfect example of a novel disease for which there is an urgent need for both vaccines and therapies. To help reduce the application review timelines, the FDA issued guidance for Pre-IND meeting requests in May. We summarize the recommendations and provide advice from our regulatory affairs team.
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.