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FDA pushes virtual clinical trials during coronavirus outbreak

March 18, 2020, 6:53 PM UTC

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Happy Wednesday, readers.

I want to start off with an announcement: Our 2020 Fortune Brainstorm Health conference, which was scheduled for April, has been postponed.

This was a difficult but necessary decision given the realities of the coronavirus outbreak and the advice of public health officials. We will still be holding a virtual and interactive gathering of the greatest minds in health care on July 7 and reconvening in California in April 2021. If you had already registered and want more information, head over here.

It’s just another example of how this situation is upending our daily lives (and will continue to for many months). Here’s another: The Food and Drug Administration (FDA) has now issued guidance that certain clinical trials be conducted virtually.

The agency noted that a combination of factors could significantly hamper clinical trials for a drug. For instance, the supply chain for an experimental treatment may be affected by the outbreak, hampering manufacturing capacity; a study participant may actually become sick with COVID-19; quarantines may be in effect in certain hot zones.

In a situation like that, the FDA says clinical researchers should consider following up with trial participants virtually or via phone, particularly for safety monitoring of patients who may not be able to go to the site where a study was being conducted or have access to an experimental treatment.

This is part of a broader wave of government and health officials urging virtual doctor (not to mention social) visits during this time.

Read on for the day’s news.

Sy Mukherjee


Hackers capitalize on the coronavirus crisis. When there's a crisis, there's a conman. The COVID-19 outbreak is no different. My colleague David Z. Morris reports the multiple nations have been hit with coronavirus-related phishing scams, which can be particularly effective in a pandemic situation and as people are hunkered down in their homes. This is per research from the cybersecurity firm Nocturnus, which also found that there's been instances of coronavirus-related ransomware that forces users to pay hackers money in order to unlock their computers' hard drives. (Fortune)


Illumina partners with IDbyDNA to sequence infectious diseases. Genomic sequencing giant Illumina is teaming up with IDbyDNA to market a platform called "Explify." This particular technology can sniff out thousands of pathogens from environmental samples and, as you might suspect, the partnership was fueled by a desire to expand coronavirus surveillance options. It will also center on stepping up laboratory capacity to test for infectious diseases. (FierceBiotech)


How hard will coronavirus hit the economy? Some economists are warning that the economic toll from the coronavirus could get significantly worse in the coming months, including as many as one million lost jobs in March alone. But others are more cautious, predicting that employers won't be eager to slash their workforces if the situation proves more fleeting. Economic indicators certainly aren't great at this point(Fortune)

What hospitals want from the stimulus bill. As Congress debates yet another bill to assist in the coronavirus fight—this time tailored specifically for the need of hospitals and healthcare workers—the medical community has a wish list. Some of the largest hospital trade groups in the country are requesting a variety of relief measures including a pause on cuts to Medicare reimbursement rates, more protective gear for health workers, child care support for medical staff with children, and more. (ModernHealthcare)


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