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.
FHI Clinical has found that our sponsors and our own teams face a number of challenges to patient recruitment in COVID-19 trials. In this blog post, we discuss these limitations and how FHI Clinical is working with sponsors to develop strategies to address them.
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.
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.