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…

As Coronavirus Continues to Spread in the U.S., the Clinical Trials Cancer Patients Rely on Are Disappearing
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.”

Source : Time More   

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The U.S. Now Has 4 Million COVID-19 Cases, With No End in Sight

And that number is likely an undercount

The U.S. Now Has 4 Million COVID-19 Cases, With No End in Sight
according to Johns Hopkins University, with more than 143,000 deaths.

That number is likely an undercount—a Centers for Disease Control and Prevention study published Tuesday found that the actual U.S. infection rate could be anywhere from six to 24 times higher than the official total. Even still, the 4 million mark is chilling enough.

The U.S., unlike the European Union, China and other previous hotspots, has utterly failed to flatten the infection curve, and instead becomes more of an outlier every day as cases mount.

The pain is not spread evenly across the country. States like California, Georgia, Texas, Oklahoma and Arizona, many of which reopened relatively early, are experiencing exploding caseloads. Meanwhile, the Northeast, once the nation’s hotspot, has cooled considerably. Just this week, California, with more than 409,000 cases, surpassed New York—which has reopened only cautiously, with movie theaters, museums and health clubs still shuttered in parts of the states and indoor dining still forbidden in New York City—for highest case count, though New York’s death total, which exceeds 32,000, remains the nation’s highest so far.

Hospitals are reaching capacity in the hardest hit parts of the country, as a data tracker from the U.S. Department of Health and Human Services reveals. In California, for example, hospitals have reached more than 97% capacity, while over a quarter of those hospitalizations are related to COVID-19. Arizona hospitals are at 94% full and 41% COVID-19-related, respectively, while Georgia is at 77% and 33%. Meanwhile, New York—which during the spring had resorted to setting up emergency makeshift hospitals in Manhattan’s Jacob Javits Convention Center and Central Park—is at just under 77% hospital capacity, but only 5.67% of inpatients are there for COVID-19.

Death rates, for now, are not climbing as fast as case counts. Currently, the U.S. represents 26% of cases worldwide, but a slightly less severe 22% of all deaths. That can give rise to all manner of misinformation—not least being that the virus is somehow growing less lethal. But deaths and hospitalizations have been lagging indicators throughout the pandemic. Fatalities may trail infection rates by as much as a month, which means that a dip in cases in one state in, say, June, may lead to a dip in deaths in July—even as cases in July spike.

It is a certainty that 4 million cases will not be the last dark milestone the U.S. crosses. The death toll is projected to approach a quarter of a million as early as November 1. If case counts climb commensurately, that will put us at nearly 7 million known cases a few weeks before Thanksgiving. COVID-19, which first clobbered the country in early 2020, will remain very much our national plague into 2021.

Correction, July 23: The original version of this story misstated the number of COVID-19 deaths in New York so far. That number is more than 32,000, not more than 72,000.

Source : Time More   

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