The rising scourge of the unpredictable coronavirus has made remote trials and remote monitoring more attractive concepts to many in recent weeks. “We’ve seen a lot of interest in telemedicine” and virtual clinical trials, says Kim Kundert, RN, BSN, vice president of operations at VirTrial, a technology firm with a virtual care platform customized for clinical trial use.
With patient retention such a challenging issue even in the best of times, virtual clinical trials might help to calm patients who are on the fence about continuing in a trial today if it means risking in-person contact at a site or a visit from a monitor, says Derric Frost, vice president with VirTrial. “The only way to help alleviate this is with virtual visits,” he says.
Additionally, telehealth has already been shown to reduce clinical trial “no shows” by about 30% in less dire conditions, Frost adds. Telehealth could also help clinical trial monitors who find their travel limited in the coming days and weeks because of virus fears, he notes.
Earlier this year, as reported cases of the virus began to spread from Asia to Europe and the United States, the Centers for Disease Control (CDC) said it was “leveraging existing telehealth tools to direct people to the right level of healthcare for their medical needs,” as it stressed the potential value of telehealth in combating the spread of Coronavirus.
The virus is a moving target for health officials across the United States and globally. As of early today (March 10), the U.S. death toll had climbed to 26, infections have spread to all but a handful of states, and two cruise ships languished on each side of the country as the coronavirus rolled unabated across the nation and around the world.
The global death toll that has now topped 4,000 and the number of confirmed cases approached 115,000.
Yesterday, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission issued warning letters to seven companies for selling fraudulent “Novel Coronavirus Disease 2019” (COVID-19) products. These products are unapproved drugs that pose significant risks to patient health and violate federal law. The warning letters are the first to be issued by the FDA for unapproved products intended to prevent or treat COVID-19.
“The FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health. We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one,” said FDA Commissioner Stephen M. Hahn, MD. “We understand consumers are concerned about the spread of COVID-19 and urge them to talk to their healthcare providers, as well as follow advice from other federal agencies about how to prevent the spread of this illness. We will continue to aggressively pursue those that place the public health at risk and hold bad actors accountable.”
The WIRB-Copernicus Institutional Review Board (IRB) service last week (March 6) announced a new program to support initiation of protocols associated with mitigating the global spread of coronavirus. WIRB-Copernicus IRB will give prioritized review to clinical trial protocols for COVID-19 prophylactic or therapeutic vaccines and therapeutic agents conducted under an Investigational New Drug application. It will also waive the initial protocol review fees for that research. To qualify for this new program, the COVID-19 protocol must be submitted before September 1, 2020. Interested parties should contact Amy Hutnik at email@example.com.
Author: Michael Causey