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A researcher works in a lab that is developing testing for the COVID-19 coronavirus.
- The coronavirus is making things difficult for researchers trying to find cures to for diseases like cancer, heart disease, and neurological disorders.
- While sick patients are increasingly confined to their homes, drug makers are trying to get creative about how to get them their medication and monitor the results.
- Some trials and studies, however, have been delayed indefinitely.
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The novel coronavirus has upended clinical trials as medical centers and pharmaceutical companies slow, stop, or modify them to protect patients from the outbreak.
Scientists are balancing the need to continue research on experimental drugs against the risks that people in clinical trials could be exposed to the novel coronavirus when they show up to healthcare facilities. Plus, hospitals in outbreak hotspots are shifting their attention to treating the coronavirus, leaving fewer resources for everything else.
As a result, biotechnology and pharmaceutical companies are trying to figure out how to keep some trials up and running. In some cases, they're developing new ways to keep patients at home and still collect crucial data.
Efforts deemed less essential, like early-stage studies that involve healthy people, are on the chopping block as patient enrollment slows, offices close, and healthcare workers sent to the frontlines leave medical centers with skeleton crews, according to analyst notes and company announcements reviewed by Business Insider.
The US Food and Drug Administration on Friday told drug developers that the safety of trial participants is paramount and acknowledged that normal research protocols may be difficult to meet.
Dozens of biotech and pharma companies report disruptions
Significantly fewer trials are moving closer to reporting results, according to federal data analyzed by Ronny Gal, an analyst at AllianceBernstein, in a March 30 research note. New trials were down by more than 65%, and trial suspensions more than doubled as compared to typical weeks.
The disruption has affected drugmakers of all sizes as they either pause enrollment, suspend the addition of new sites that administer the treatments, or hold off on launching new studies, according to research published last week by RBC Capital Markets.
Indeed, at least 40 biotechnology and pharmaceutical companies have put out guidance about the impact of the coronavirus, not including those that announced development of a coronavirus-related therapeutic or vaccine, according to a March 27 report by Baird. Many of those said they were delaying trials or pausing enrollment in them.
A tracker from BioPharma Dive shows that more than three dozen companies have reported disruptions to their research.
Research delays are a big threat for small biotechs
For hundreds of small biotechnology companies, trial disruptions could carry serious business repercussions. Most small biotechs don't generate revenue from selling drugs, because they don't have treatments on the market. Instead, they're in the process of developing new drugs and depend on raising cash from investors to keep going.
In order to keep the funding flowing, these companies depend on producing clinical data that demonstrate the value of their programs, Bruce Booth, a partner at Atlas Venture, wrote in a March 26 blog post. He called this data "the ultimate currency of progress and market value" for biotechs.
With studies on hold, a lot of those results could face delays. Booth urged industry executives and board members to develop contingency plans to weather this crisis.
Biotech firm, Vertex Pharmaceuticals is continuing a number of its cystic fibrosis studies that are fully enrolled or nearing full enrollment, such as its study for children ages 6-11, a spokesperson for the company said in an email. Vertex is working with providers to enable virtual visits and deliver the drugs to people at home.
BridgeBio Pharma, which makes drugs for neurological disorders, heart disease, skin disorders, and other conditions, expects to delay some trials and studies, according to Baird.
The company declined to provide details about the status of its trials, but chief executive Neil Kumar said healthcare institutions and doctors have been shifting their focus to coronavirus cases in an open letter to patients on March 19.
Giant drugmakers are affected, too
"Many hospitals and physicians have postponed elective medical procedures and delayed the start of new clinical trials," Kumar wrote. "We support these steps, which are needed to minimize the devastating impact of this global pandemic."
Global drugmakers aren't insulated from the disruptions, either. Bristol-Myers Squibb said it wouldn't activate any new sites for ongoing studies until at least April 13 in a letter to clinical trial investigators on March 20. It also temporarily suspended screening and enrollment for cellular therapy studies, according to Baird.
The company declined to comment beyond the letter.
Pharmaceutical giant Eli Lilly's clinical trials will continue for patients that are already enrolled, but new studies will be delayed, and enrollment for ongoing studies will be paused, Baird's report said.
Allergan, another large drug maker, stopped recruiting in at least two trials for drugs that could treat dry eye and a group of diseases known to cause blindness, according to Bernstein.
Neither company responded to written requests for comment.
SVB Leerink LLC "Oncology Development May Pause for COVID-19", March 26, 2019. Reprinted with permission.
According to SVB Leerink's interviews with experts, some trials will be more affected than others.
Responses from academic medical centers and research groups have varied from suspension of all research involving humans to relying on investigators' discretion, according to an article in the Journal of the American Medical Association.
New York City is the epicenter of the coronavirus outbreak and a medical research hub
Roughly two-thirds of clinical trials are being disrupted at the Feinstein Institutes for Medical Research, the clinical research arm of New York health system Northwell Health, CEO Kevin Tracey said.
Cancer trials, rheumatology trials, and cardiac trials as well as studies for life-threatening conditions are ongoing as patients continue to come in for normal care and treatment, he said in an interview.
But between fewer patients coming in, slowed enrollment, and closures of certain physician offices, participation has declined, according to Tracey.
"There has been an impact," he said, adding that trial enrollment has slowed for patients "that are not on a critical path for their health."
New York City is the epicenter of the US coronavirus outbreak and a big hub for medical research. Five prominent oncologists in New York City with active clinical and research programs told SVB Leerink that recruitment for oncology drug development has practically halted, according to a report on March 26.
Outside the metro area, however, "we heard some similar drivers of slow-down in trial activity, e.g., skeleton trial administration staff, but more optimism that trial enrollment and monitoring will proceed on the most important trials," the SVB Leerink analysts wrote.
'They postponed my treatment without a new start date'
At Columbia University Irving Medical Center and Children's Hospitals and Clinics of Minnesota, studies that use healthy volunteers are suspended, and enrollment is paused for both new and ongoing trials. That's according to Ran Reshef, the clinical lead of the CAR-T cell program at Columbia and Stuart Winter, the chief research officer at Children's, who spoke on a call with Oppenheimer's healthcare analysts.
Patients who are already enrolled will continue to be treated, sometimes through telemedicine and local centers - even when they're not pre-screened or compliant with existing protocols, according to Oppenheimer.
TrialJectory, a company that matches cancer patients with clinical trials, surveyed 70 participants in recent days, finding that most were participating in trials that stopped recruiting new people, according to a spokesperson.
Nearly 70% said they would still be willing to participate in a clinical trial to increase their chances of survival.
"I don't know what will happen to me," one patient with breast cancer, who wished to remain anonymous, wrote to TrialJectory. "They postponed my treatment without a new start date."
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