COVID-19 Ends Clinical Trial, Endangers Patient Care: Shot

A phlebotomist collects blood from patients who are participating in clinical trials for cancer treatment. Hundreds of studies are pending as the hospital focuses on COVID-19.

Jim West / Science Source


Hide description

Toggle caption

Jim West / Science Source

A phlebotomist collects blood from patients who are participating in clinical trials for cancer treatment. Hundreds of studies are pending as the hospital focuses on COVID-19.

Jim West / Science Source

Rene Roach sent a quick email in late March with updates on colorectal cancer clinical trials he had hoped to qualify.

Concerned about the coronavirus, she asked almost as an afterthought if the study was postponed due to a pandemic. The answer crushed her: it had been.

“At that time, COVID-19 shut down everything,” says 50-year-old Roach of Germantown, Maryland.

Roach assumed that patients with stage IV cancer, such as her, had workarounds. These patients often rely on clinical trials as the best opportunity to knock out the cancer if other treatments fail.

So far, she has been treated with traditional chemotherapy, but she was expecting drug cocktails from clinical trials. She thinks that if chemotherapy is going to get rid of cancer in her body completely, it will already be doing so.

“It’s time for the purchase, but how long is it? I don’t know,” she says. “So, if this stops working, what else is there?”

The pandemic of COVID-19 has forced hundreds of clinical trials to stop, stalled research on cancer, stroke, and dementia, and found NPR analysis of federal clinical trial data.

As Americans are told to stay home to prevent the spread of the new coronavirus, people enrolled in clinical trials are notified that those trials have been interrupted or will not start as originally planned .

The NPR has identified 440 studies that have been discontinued since March 1 due to an outbreak. About one-quarter of the pending studies involved cancer treatment. Although the study involved as many as 200,000 people, it is difficult to know exactly how many people are actively involved in the study at the time of discontinuation.

“What really hinders patients’ ability to receive treatment in clinical trials is the set of effects that occur here,” he said. Dr. Richard Silsky, Chief Medical Officer of the American Society of Clinical Oncology. “I have heard that registrations have decreased, at least anecdotally.”

Pharmaceutical companies, university medical centers, hospitals, and local research centers all say they have suspended various research projects due to outbreaks Dr. Lindsay McNair, Chief Medical Officer of WIRB-Copernicus Group, a company that provides ethical and regulatory reviews of clinical trials.

She says many institutions will try to continue research if the patient has a “direct benefit,” but it can be unclear where to draw that line. As a result, organizations are considering whether to shut down on a case-by-case basis.

An important consideration is whether additional study participants’ visits to the healthcare facility are commensurate with the risk of transmitting the coronavirus. Another factor is whether medical staff can continue testing while COVID-19 is straining hospitals and clinics.

It is incredibly difficult for patients, says McNair. “Many of these people have long waited for clinical trials.”

Sirsky said he had heard of studies that required stopping biopsies, for example, due to the closure of a hospital radiology facility.

“It creates a real challenge,” he says, especially if a biopsy was needed to determine if the treatment worked for the patient. “The data from many studies that were eagerly anticipated will take quite a long time to develop. It will only slow down the entire cancer research company.”

If freezing these tests also has long-term effects, Ken Kaitin, Oversees Tufts Center for drug development research.

“If you’re praying for brand new medicine, you probably will have to wait longer than expected,” Kaitin says.

The roach of the cancer patient does not know when the exam she wants to participate will resume. It could be several months or more. If her cancer has progressed, she may have progressed until she is no longer eligible to participate.

“We now know we live in this world of anxiety … and many people are dying from this disease and the virus,” she says. “As you know, we are dying of cancer here, just to stop things. I don’t know. It’s not really fair.”

Clinical trials are very important for patients with cancer and other serious conditions. Sometimes, that is the only care they can access. In other cases, it is their best shot to keep the disease out.

“For many patients, enrolling in a clinical trial is the difference between staying alive to reach their next birthday and the child’s next birthday.” Lena Conti, A health economist at Boston University. “And this new reality in which we live has a real serious impact on people’s health, but also has the ability to care for the family, and ultimately the ability to work.”

Conti is a principal investigator in research on the economic burden of cancer. This is a survey base. This means that the patient does not need to go to a medical facility for blood sampling or other tests. However, enrollment of new patients has been terminated because the recruitment included patient consultation at the clinic.

And it’s not just cancer trials that have felt the benefits of COVID-19.

Craig Reperto, who lives in Los Angeles, is looking forward to a clinical trial that will allow him to spend a long time outdoors in the sun for the first time in his life. He has Hematopoietic protoporphyriaA rare enzyme abnormality that causes chemicals to accumulate in the blood and skin, making them sensitive to sunlight.

The pain is like a “combination of breaking, accidentally cutting yourself, or burning in a hot stove,” says 29-year-old Leffert. A little like that. There is nothing to relieve pain. “

He participated in the first two clinical trials of a drug that prevented this reaction, but did not have access to the drug because he was in the placebo group.

In the next phase III clinical trial, everyone will get the drug after six months. He acknowledges that he has begun to expect this summer to be able to do what he normally has to avoid, such as going to the beach.

However, Referert resigned to wait. “Hey, this is the rule of the game,” he says. “Another summer we will get through it.”

He is disappointed, but knows that it is even harder for the sick children who need to face another summer indoors while friends play outside. They will also have an eve unable to sleep due to pain for a few minutes in the sun, he says.

“People may be waiting for life-long treatments that get stuck or delayed,” he said. Pamela Gavin, Chief Strategy Officer of the National Rare Disease Organization. “But the community is full of hope.”

She says the rare illness community is used to rolling with punches. “It’s a really elastic group of people.”

However, some studies are applicable. Food and Drug Administration Published guidelines COVID-19 Increases flexibility during a pandemic.

Cedron WilliamsLeading the clinical trials office at East Carolina University in Greenville, North Carolina, the agency’s relocation has allowed it to talk to research sponsors and allow patients who depend on them to continue their trials. I am.

In some studies, he has his work cut off because even a slightly delayed test is a deviation from the protocol.

“I think it’s really important that there is room for immediate change under federal guidance,” he says. “If there was no COVID-19 response, I think there was no room for such flexibility.”

Some studies have been tailored to mail patients’ drugs or rely on telemedicine instead of face-to-face consultations, says McNair.

Others continue to make smaller changes.

Beth Anastasia, living in Mount Laurel, NJ, with stage IV non-small cell lung cancer, went to her husband’s first clinical trial infusion last week. This facility has enacted a new policy to prevent the spread of COVID-19.

“I have a wonderful husband who goes to all the smell infusions, sits in the cheesy guest chair, and then spends every other Thursday with me,” she says. “He can’t do that anymore.”

They usually talk less during the infusion, but the company was a source of comfort. “It was support for someone being there-for both of us-that’s important,” she says. “And it was strange that he wasn’t there.”

But Anastasia knows that the policy is being implemented for good reason.

“I have a temporary care team,” she says. “And because they keep me secure, I want to keep them secure.”