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Compliance In Focus
Posted by Ashton Steinhagen on Tue, Mar 10, 2020

The Coronavirus (COVID-19) and Clinical Research

2019-coronavirus


With the uncertainty of the coronavirus (COVID-19), the impact of this global health issue remains to be seen. Recently, the FDA issued a news release indicating that together with help from the centers for disease control (CDC), they are trying to make more respirators available for health care personnel. The CDC requested emergency use authorization (EUA) which would allow the use of certain industrial respirators in the healthcare setting. These normally would not be approved for use in the clinical setting; however, the FDA stated that “…they may be effective in preventing health care personnel for airborne exposure, including the COVID-19.” As more cases continue to develop locally as well as abroad, more directives and urgent measures may occur.

The COVID-19 virus is similar to other coronaviruses; however, little is known about this specific strain or strains. Globally, several biopharma companies are initiating clinical trials to work on developing a vaccine. While many companies are initiating these studies, vaccines are likely 12-18 months away from being introduced into the general public if successful. A few notable companies who have started exploring vaccine clinical trials include Johnson and Johnson, GlaxoSmithKline, Clover Biopharmaceuticals, and Inovio Pharmaceuticals.

Outside of vaccination and preventative clinical trials, there are also a few trials that are working on using drugs as treatment for the COVID-19 virus. The National Institute of Allergy and Infectious Diseases (NIAID) initiated a randomized, controlled trial for an experimental antiviral using Remdesivir from U.S. drug maker Gilead at the University of Nebraska Medical Center in Omaha. This trial is aimed at treating individuals who have been confirmed to have the COVID-19 virus. It’s important to note that currently there isn’t an approved treatment for the COVID-19 virus yet; however, Remdesivir has been shown to help in animal models against similar coronaviruses such as the Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS). China also approved Favilavir as an investigational therapy to treat the virus. It was reported that the National Medical Products Administration of China gave clearance for the investigational use for subjects in the Shenzhen, Guangdong province. Some reports from this trial state that there were positive signs demonstrated with minimal adverse reactions; however, the results have yet to be published.

With this global health issue and the urgency surrounding it, more and more clinical trials, urgent measures, and federal guidances will likely take place. The impact of this virus for clinical trials and the biopharmaceutical industry has already been prevalent but other clinical trials, even those not involving the COVID-19 virus will likely, if not already, be impacted due to travel restrictions, quarantine orders at institutions and hospitals, and delayed or interrupted manufacturing processes. What other trends in the clinical research industry do you anticipate as a result of the COVID-19 virus?

Executive Summary

Topics: Clinical Research, The Coronavirus, COVID-19

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