Cancer drug clinical trials not interrupted by COVID-19 pandemic

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The pandemic has largely disrupted medical care in the United States, but a new study reports that clinical trials testing cancer treatments may have continued.

Researchers found that cancer trials in the United States responded quickly to the pandemic in the first few months, allowing studies to get back on track after an initial – and steep – decline in patient participation.

This was especially true for trials testing cancer treatments, the study found. Trials focused on cancer prevention have seen larger declines in participation – declines that will likely delay the results of these studies, experts said.

“It makes sense to me that cancer prevention trials have been hit more than treatment trials,” said Dr. Julie Gralow, chief medical officer of the American Society of Clinical Oncology.

“Cancer cannot be put on hold and we cannot stop treating patients,” added Gralow, who was not in the study.

Often, she noted, cancer patients enrolled in these trials have exhausted their treatment options and are pinning their hopes on experimental therapy.

That’s why, in the spring of 2020, government regulators quickly released guidance on how clinical trials could continue to be conducted safely. And based on the new findings, the adjustments seem to have worked, at least for cancer treatment trials.

In the first year of the pandemic, these trials maintained 91% of their planned recruitment.

It’s a remarkable discovery, said study leader Joseph Unger of the Fred Hutchinson Cancer Research Center in Seattle.

“We were very surprised,” he said. “Considering the impact on trial registration early on, it didn’t seem likely that we would recover so quickly.”

The picture was different for trials focusing on cancer prevention or other aspects of cancer care, such as symptom management or the long-term health of cancer survivors. Enrollment in these trials was 54% of what would normally be expected.

According to Unger, the emphasis on sustaining treatment trials may have come at the expense of these other studies.

“Our guess is that the sites have probably prioritized treatment trials,” he said.

Gralow said it was “very disappointing” that the results of prevention trials were likely to be delayed.

The results – published online Thursday in JAMA network open – are based on nearly 30,000 patients who participated in cancer clinical trials in the United States between 2016 and February 2021.

In March and April 2020, there was a substantial drop in weekly clinical trial registrations across all areas. But that was followed by a rebound – so registrations were actually higher at the end of the summer than one would expect during the pre-pandemic period.

Gralow said the trials made various changes to limit patient travel and exposure to major medical centers. Some things could be done over the phone or at virtual doctor’s visits, and when they couldn’t – blood or imaging tests, for example – patients could have them done at a local outpatient clinic.

Now, said Gralow, the big question is whether any of these measures should be made permanent.

“We want, outside of the pandemic, to make it easier for patients to enroll in clinical trials,” she said. “Can we build in more flexibility and bring the trial to the patient?” “

Unger agreed and said researchers will need to study the impact of pandemic changes – including whether they have affected patient care in any way.

In another positive finding, there was no sign of a sharper decline in enrollment of black and Hispanic patients into treatment trials.

Unger said it was encouraging for a number of reasons: Black and Hispanic Americans have been particularly hard hit by the pandemic and they have traditionally been under-represented in clinical trials.

On the flip side, according to the study, prevention-focused trials saw declines across all demographic groups, particularly black and Hispanic patients and women.

Researchers hypothesized that women could have been more affected than men, in part because of their higher rate of job losses during a pandemic or because they had to stay home with their children. .

Gralow stressed that clinical trials are the only way to advance treatments. Hopefully, she said, the trials may make it easier for patients to participate in the future.

More information

The National Cancer Institute in the United States has more information on participate in clinical trials.

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