The Colors of COVID Town Hall Event: The Ethical Engagement of Minority Communities in COVID Clinical Research

In April, the Director of the Maryland Center for Health Equity’s Dr. Stephen B. Thomas partnered with FHI Clinical for a frank conversation by experts about COVID and how to encourage Brown and Black communities to participate in clinical research.

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The Elusive COVID-19 Patient: Subject Recruitment Remains Challenging Despite Increasing Case Numbers

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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.

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“A pandemic is a communications emergency as much as it is a medical crisis”

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.

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Without Quality Data, We Cannot Develop Effective Vaccines and Therapies

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?

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The Sooner, the Better: Planning for FDA Pre-IND Review of COVID-19 Studies

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.

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Pandemic Experience Means Expert Guidance

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.

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Data: The Key to Effective Outbreak Responses

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.

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