Clinical trial disruptions are new norm, survey finds

March 27, 2020
It’s Friday. As we close a busy week, and prepare for another one ahead, here’s a 680-word read (3 and a half minutes) on our new survey with BioCentury on how COVID-19 is affecting clinical trials—and some thoughts on the industry’s incredible work to collaborate.
BIO

It’s Friday. As we close a busy week, and prepare for another one ahead, here’s a 680-word read (3 and a half minutes) on our new survey with BioCentury on how COVID-19 is affecting clinical trials—and some thoughts on the industry’s incredible work to collaborate.

Clinical trial disruptions are new norm, survey finds

 
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In news that’s likely surprising to no one in the industry, COVID-19 has disrupted the biotech industry—particularly clinical trials, finds a new survey conducted by BIO and BioCentury. Let’s dig in.

About the survey: Conducted between March 16-19, 2020, the survey asked 99 pharmaceutical and biotech companies about how COVID-19 is affecting their ongoing and planned clinical trials; 87% of companies surveyed are U.S. companies.

The key finding: ¾ of the respondents “said their ability to start new trials or to continue active trials has been hindered by the coronavirus outbreak,” reports BioCentury, with 15 companies reporting they had delayed the start of one or more trials, and six companies suspending enrollment in one or more trials.

 
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Companies are taking action to keep trials running or start new ones—“from increased communication with clinical CROs, to review of enrollment numbers and statistical plans to define leeway for modification, to active implementation and documentation of protocol changes,” as well as “remote monitoring of data” and “virtual patient visits.”

But above all, companies need guidance and flexibility from the Food and Drug Administration (FDA)—at the same time the agency is “simultaneously trying to expedite a large volume of development of programs for COVID-19.”

And while these findings are dismal, there’s one bright spot: intense industry collaboration. As we explained yesterday in our recap of our virtual coronavirus summit, there’s a strong desire to collaborate and work through the crisis as quickly as possible—and to quote Vir Biopharmaceuticals’ Dr. George Scangos, this crisis is “bringing out the best of what the industry has to offer.”

Click here to read more about the survey in BioCentury.

Click here to watch the BIO virtual coronavirus summit opening plenary:

 
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More Health Care News:

NPR: How monoclonal antibodies might prove useful against the coronavirus
“Scientists working to quell the COVID-19 pandemic think it will be possible to figure out which antibodies are most potent in quashing a coronavirus infection, and then make vast quantities of identical copies of these proteins synthetically.” 

Reuters: Sanofi and U.S. group Translate Bio to work on COVID-19 vaccine
“Translate Bio would work on discovering, designing, and manufacturing a number of SARS-CoV-2 vaccine candidates, while Sanofi would provide its expertise in the field of vaccines and support from its research networks.”

STAT: Pharma CEO in Italy sounds a note of caution on COVID-19
“Drug development is a long, long, long process,” Massimo Scaccabarozzi, CEO of Johnson & Johnson’s Janssen unit based in Milan. 

The Wall Street Journal (Opinion): The history of Pfizer and penicillin, and lessons for coronavirus
Former biotech CEO Safi Bahcall praises the pharmaceutical industry’s ability to come together during a crisis and calls for a “scientist general” in Washington.

 

More Agriculture & Environment News: 

Reuters: U.S. EPA considers delaying compliance deadline for biofuels law
“The U.S. Environmental Protection Agency is considering whether to delay the deadline for oil refineries to comply with the nation’s biofuel regulation past March 31, to help the industry cope with fallout from the coronavirus, agency chief Andrew Wheeler said on Thursday.” 

Reuters: Trump administration eases environmental enforcement during outbreak
“The EPA said in a memo outlining the changes that it does not plan to fine polluting industries for violating certain monitoring and reporting requirements during the outbreak. It added that the EPA will now ‘focus its resources largely on situations that may create an acute risk or imminent threat to public health or the environment.’” 

Euractiv (Opinion): How biofuels enter the race against the coronavirus pandemic
“Biofuels, especially ethanol, are food and fuel and a bit of flexibility,” writes a sustainability consultant.

 
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President Trump’s Friday: The Coronavirus Task Force is scheduled to hold a press briefing at 5pm ET.

What’s Happening on Capitol Hill: The House is reportedly planning to vote on the $2 trillion coronavirus package passed by the Senate; House members will vote remotely by voice vote. The Senate is planning to stay away until at least April 20.

 
 
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