New story in Health from Time: As Coronavirus Continues to Spread in the U.S., the Clinical Trials Cancer Patients Rely on Are Disappearing

Tori Geib was already on high alert when COVID-19 hit last winter. Diagnosed with metastatic breast cancer in 2016, the Ohio chef went from one chemotherapy regimen to another in an effort to outrun the cancer that had spread from her breast to her bones, lungs and liver. To protect her-self from infections, even before the pandemic she often wore masks when she went out in public and carried hand sanitizer at all times. But COVID-19 presented a new and daunting challenge.

At some point, Geib knew, she would exhaust all approved treatment options and would need to move to experimental therapies. But when COVID-19 began to burden hospitals, many suspended clinical trials. “It made what limited options I had even more limited,” she says. “When your cancer is growing and progressing, you want to know what the next thing is that you will have access to. COVID-19 brought in a new fear: Will that research or trial be there when I need it?”

Three months ago, Geib learned her cancer had progressed, so she again changed to a different chemotherapy. At the end of June, she learned the cancer had spread to her brain, so she received radiation treatment. She is also taking another off-label therapy while waiting for more clinical trials to become available near where she lives. “I’m trying to navigate the system and find the next thing I need to go to.”

Estimates of how many cancer patients enroll in clinical trials range from 2% to 8%. But since the pandemic began, the National Cancer Institute (NCI), which sponsors many cancer trials in the U.S., says enrollment in trials has dropped by about 10% each month. The potential impact is profound. “First, it’s a missed opportunity for patients to actually avail themselves of participating in a clinical trial if the trial is on hold or temporarily suspended or even closed,” says Dr. Richard Schilsky, chief medical officer and executive vice president of the American Society of Clinical Oncology. “The longer[-term] impact is that the time to complete trials is going to be longer than originally planned because enrollment has taken a big dip for a period of months, and it will take time to make that up. That means it will take longer to get an answer to a trial and longer to potentially bring new therapies to patients.”

With limited resources, many study sites decided to triage their clinical trials, suspending early-phase studies, in which the benefit of the experimental treatment is largely unknown, in favor of keeping later-stage studies, which test treatments that have already shown some promise. “All of these decisions are based on benefit-risk assessment,” says Schilsky. “What is the risk of interrupting, delaying or discontinuing a patient on a cancer treatment, especially if they have an aggressive, rapidly progressive cancer, vs. the risk of continuing treatments that require them to come into a health care facility for frequent visits, risking exposure to COVID-19 infection?”

Normally, study conditions require patients to come to the trial site to receive their medications along with instructions on how to take them. To keep some trials going during the pandemic, the Food and Drug Administration and the NCI worked to allow study sponsors to ship experimental therapies directly to patients. Similarly, virtual checkups replaced in-person visits when possible, further reducing COVID-19 risk for trial participants.

Time will tell how those changes affect the results of clinical trials; for example, it’s possible the lack of medical oversight will affect compliance with taking medications. But Schilsky notes there may be a silver lining. “Many of the adaptations make it easier for patients to participate in clinical trials,” he says. “So if they work, there may be no reason to go back to the old way of doing things. Hopefully the adaptations made during the pandemic will position us to do clinical trials more effectively than they’ve been done in the past and ultimately open them up to more patients.”

New story in Health from Time: COVID-19 Has Been ‘Apocalyptic’ for Public Transit. Will Congress Offer More Help?

While trying to get to work over the past few months, Brittany Williams, a Seattle home care worker, has often been passed by two or three buses before one stops to let her board. Buses in her area that once carried anywhere from about 50 to 100 passengers have been limited to between 12 and 18 to prevent overcrowding in response to coronavirus, and Williams’ commute, typically a half-hour ride, now takes more than double that time. Other Seattle transit riders have described budgeting as much as an extra hour per trip to account for the reduced capacity, eating into their time at work, school or with family. Even with the ridership limits in place, Williams, 34, doesn’t feel safe on public transit. Some passengers don’t wear face coverings, and bus drivers sometimes ignore capacity limits, she says. On one ride with her seven-year-old son, she decided to get off at a stop far from her home after a driver allowed a crowd of people to board. “It’s very trying. I’ll put...

New story in Health from Time: An At-Home Coronavirus Test May Be On the Way in the U.S.

As cases of COVID-19 continue to climb in the U.S. , there’s a new urgency to make sure there are as many tests as possible to diagnose people who have symptoms that might indicate an infection. Knowing if people are positive is important for guiding their next steps: self-isolation, avoiding contact with others, and, if their symptoms get worse, seeking medical care. To date, access to tests has been spotty at best across the country, and while more kits are now available than even a week ago , most are gene-based assays that take several days for commercial labs to process and produce results. That may change in about two months if the Food and Drug Administration (FDA) gives Emergency Use Authorization to the first blood-based COVID-19 test in the U.S. Scanwell Health, an at-home test company based in California, licensed the rights to a test developed by Chinese company Innovita, which was used extensively at the height of country’s epidemic earlier this year. “The ...

New story in Health from Time: A Montana Care Home Refused Free COVID-19 Tests. Now, Nearly Every Resident Has Coronavirus

(BILLINGS, Mont.) — It was meant to be a last line of defense to protect the most vulnerable as the coronavirus spread across the United States : Montana officials offered free testing in May for staff and residents at assisted living and long-term care facilities. But not all of them followed through, according to state data, including a facility in Billings, Montana’s largest city, that cares for people with dementia and other memory problems. The virus has infected almost every resident and killed eight, accounting for almost a quarter of Montana’s 34 confirmed deaths. Thirty-six employees also have tested positive at the facility where 59 people lived before the deaths began. Read more: ‘It’s Getting Worse.’ Nursing Home Workers Confront Risks in Facilities Devastated by Coronavirus While Montana’s rates of confirmed infections and deaths are much lower than other parts of the country, the outbreak at Canyon Creek Memory Care illustrates that even the most simple an...

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