Covid-19 Stalls Clinical Trials for Everything but Covid-19
But tacking a delay onto what’s already been a lengthy search comes at a cost. “Pushing it back means some people are going to have vision loss when we could have potentially had a treatment sooner,” says Ian Terry, Sharon’s son, now 30 years old. Ian describes himself as healthy but says he keeps his fingers crossed: The disease progresses with age.
With a surge in clinical trial disruptions, doctors who are still running studies are turning to desktops and tablets, virtual screenings, and uploading paperwork remotely. When possible, medications are being mailed, and health care workers travel to deliver home care. The FDA recently encouraged the pivot, noting that some trials could go virtual. Suddenly there’s willingness to “adopt technology that exists to run clinical trials in the 21st century,” says Greg Dombal, the chief operating officer of Halloran Consulting, which advises companies on clinical trials.
“The world of clinical research is maybe 10 to 15 years behind most other industries in terms of adopting technology,” Dombal says, noting as an example that electronic signatures only became mainstream in this realm in the last year or two.
But many trials can’t be done remotely. For instance, IVs and in-hospital monitoring typically accompany CAR-T cell therapy that uses a patient’s modified blood cells to fight cancer cells.
For those eager to join upcoming trials, the disruption has been distressing—to say the least. Rene Roach pinned her hopes on an experimental cancer drug called cibisatamab, paired with other drugs. The stage-4 colon cancer patient took part in early screening for a clinical trial at Duke University School of Medicine. Then trial enrollment paused indefinitely. The culprit: Covid-19.
“I thought, ‘Maybe this is something that’s really going to help me, and who knows, maybe even cure me,’” Roach says. “But then I hear the study is suspended, and if I’m being honest, I cried.”
Roach, who is 50 years old and was diagnosed in 2016, considers herself healthy for someone with such a harrowing diagnosis. Earlier treatment blunted the cancer’s spread. As she sat on the back porch of her Maryland home, her red hair backlit in the early afternoon sun, she reflected by video chat on how this critical stretch of her life could unfold. She hopes that her current chemotherapy regimen keeps her stable until the trial starts back up. For her, the ideal scenario would be that a drug cocktail that includes cibisatamab assails the cancer, and later, surgery mops it up.
But Roach also laid out an unnerving possibility: In the meantime, her body could develop chemotherapy resistance, and with other promising clinical trials laid up, her options could narrow to third-line drugs known for nasty side effects.
In an emailed statement, representatives from Roche, the drugmaker behind the clinical trial, wrote: “The Covid-19 situation is dynamic and we are seeing some impacts on the continuity of certain clinical trials in all the regions where we conduct clinical studies. Our commitment to sites and patients is finding new and flexible ways to work.”
Meanwhile, Roach said she’s trying to keep positive: “It’s a tough situation, but we’re counting our blessings.” Behind Roach, cream-colored seashells from North Carolina’s Outer Banks were lined up on a ledge. She collected them with her family. Roach hopes the future holds many more trips with them.
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