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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.
The Elusive COVID-19 Patient: Subject Recruitment Remains Challenging Despite Increasing Case Numbers
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.
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.
We Wrote the Book on How to Approach Outbreaks Like COVID-19. See What We’ve Learned From Our Previous Experience
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.
A Unique Public-Private Partnership to Eradicate Malaria in Equatorial Guinea: Part 2 of the ASTMH Blog Series
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 at FHI Clinical’s ASTMH dinner event. FHI Clinical has also had the privilege of being involved in studies conducted by the EGMVI (now BIMEP).
At the 2019 ASTMH Annual Meeting, FHI Clinical hosted a dinner for a group of speakers and guests from all facets of clinical research to discuss strategies to keep sites active and leverage research-ready sites (and their patient populations) in areas that are not necessarily front of mind. With this blog series, we will describe some of the topics discussed during the event.
Sustaining Research Capacity at Sites in Limited-Resource Settings: What Can We Learn from Successful Sites?
Keeping a site functional, even in slow times, ensures it is ready as soon as there’s a need. Based on our experience with sites worldwide, we’ve identified the key areas on which sustainable sites proactively focus.
The Democratic Republic of Congo (DRC) is currently experiencing the world’s second-largest Ebola outbreak. Despite a coordinated vaccination and containment effort that began in August 2018, cases continue to occur and spread. As with other disease outbreaks in limited-resource countries, numerous factors have challenged the Ebola health care response in the DRC.
We hope you’ll join us in celebrating our launch as a full-service contract research organization (CRO)! With a focus on mission-driven clinical research, we have the global expertise, responsive approaches and proven solutions to manage complex clinical research across dozens of therapeutic areas in resource-limited settings around the world. Read