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.
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.
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.
Rules for managing outbreaks were created long before COVID-19. How do we know? Because we’ve been there, we’ve studied outbreaks, and we literally wrote a book on it. Our expert team of infectious disease clinical research specialists have studied outbreaks such as H5N1, HIV, Zika and Ebola. This e-book includes eight key points based on lessons learned from the front lines.
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.
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