Skip to main content

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.”

Labels:

Popular posts from this blog

New story in Health from Time: Here’s How Quickly Coronavirus Is Spreading in Your State

The novel coronavirus pandemic is a global crisis, a national emergency and a local nightmare. But while a great deal of the focus in the U.S. has been on the federal government’s response, widely criticized as slow and halting , the picture on the ground remains very different in different parts of the country. A TIME analysis of the per capita spread of the epidemic in all 50 states and Washington, D.C. found considerable range in the rate of contagion, and, in some parts of the country, a significant disparity compared to the national figure. The U.S., unlike nations such as South Korea and now Italy , has yet to show signs of bringing the runaway spread of the virus under control. However, while no single state is yet showing strong signs of bending the curve , some are faring much worse than others. The following graphic plots the rise in the total confirmed cases of COVID-19 per 100,000 residents in each state, plotted by the day that each state reported its first case.
Read more

New story in Health from Time: We Need to Take Care of the Growing Number of Long-term COVID-19 Patients

On July 7, 2020, the Boston Red Sox pitcher Eduardo Rodriguez tested positive for the new coronavirus. He was scheduled to start Opening Day for the Sox, but the virus had other plans— damaging Rodriguez’s heart and causing a condition called myocarditis (inflammation of the heart muscle). Now the previously fit 27-year old ace left-hander must sit out the 2020 season to recover. Rodriguez is not alone in having heart damage from SARS-CoV-2, the virus that causes COVID-19. In a new study done in Germany, researchers studied the hearts of 100 patients who had recently recovered from COVID-19. The findings were alarming: 78 patients had heart abnormalities, as shown by a special kind of imaging test that shows the heart’s structure (a cardiac MRI), and 60 had myocarditis. These patients were mostly young and previously healthy . Several had just returned from ski trips. While other studies have shown a lower rate of heart problems—for example, a study of 416 patients hosp
Read more

New story in Health from Time: U.S. Inmates ‘Mistakenly’ Received COVID-19 Stimulus Checks. Now, the IRS Wants That Money Back

(BOISE, Idaho) — Hundreds of thousands of dollars in coronavirus relief payments have been sent to people incarcerated across the United States, and now the IRS is asking state officials to help claw back the cash that the federal tax agency says was mistakenly sent. The legislation authorizing the payments during the pandemic doesn’t specifically exclude jail or prison inmates, and the IRS has refused to say exactly what legal authority it has to retrieve the money. On its website, it points to the unrelated Social Security Act, which bars incarcerated people from receiving some types of old-age and survivor insurance benefit payments. “I can’t give you the legal basis. All I can tell you is this is the language the Treasury and ourselves have been using,” IRS spokesman Eric Smith said. “It’s just the same list as in the Social Security Act.” Read more: ‘A Double Whammy.’ Those Who Most Need The $1,200 Stimulus Checks May Wait the Longest To Get Them Tax attorney Kell
Read more