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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.
When COVID-19 was declared a pandemic, the FHI Clinical team immediately grasped the challenges that the search for vaccines and treatments would present. We’ve been here before, addressing everything from the global threat of malaria to outbreaks of Ebola in West Africa, Zika in the Americas, and chikungunya in the Caribbean during the aftermath of Hurricane Maria. In this blog post, we describe the steps to take and the critical questions to ask.
In times like the ongoing pandemic when information overload can happen very quickly, it is helpful to go back to basics. What data do we need to inform our response to a new infectious disease threat? In the presence of a novel virus for which we have little to no information, what is the best approach to minimize the risks? In this blog post, we discuss the importance of reliable data during outbreaks.
As FHI Clinical begins supporting rapid start-up of clinical trials vital to containing the spread of COVID-19 and protecting the global community, we are also adapting our ongoing work to the new reality of this global pandemic. We are closely monitoring the situation on the ground in the countries where we work and repurposing team members to support COVID-19 response needs.