Clinical trials of anticancer drugs not stopped by the COVID-19 pandemic

Although the pandemic has disrupted medical care across the United States, new studies report that it was able to continue clinical trials testing cancer treatments.

Researchers have found that cancer trials in the United States responded quickly to pandemics in the early months, allowing the study to return to orbit after the first (and sharp) decline in patient participation. did.

This was especially true for trials testing cancer treatment, the study found. Experts say that trials focused on cancer prevention are likely to significantly reduce participation and delay the results of these trials.

Dr. Julie Gralow, Chief Medical Officer of the American Society of Clinical Oncology, said:

“We can’t put the cancer on hold and we can’t stop treating the patient,” added Gralow, who wasn’t involved in the study.

In many cases, she said that cancer patients enrolled in these trials have run out of treatment options and are looking forward to treatment.

Therefore, in the spring of 2020, government regulators quickly released guidance on how to keep clinical trials safe. And based on new discoveries, the adjustment seems to have worked, at least in cancer treatment trials.

During the first year of the pandemic, these trials maintained 91% of the expected enrollment.

This is a remarkable discovery, said Joseph Unger, research leader at the Fred Hutchinson Cancer Research Center in Seattle.

“We were very surprised,” he said. “Given the impact on early study enrollment, it seemed unlikely that we would recover so quickly.”

The situation was different in trials that focused on other aspects of cancer treatment, such as cancer prevention, symptomatology management, and long-term health of cancer survivors. Enrollment in these trials was 54% of what was expected at normal times.

According to Unger, the focus on maintaining the conduct of treatment trials may have come at the expense of these other studies.

“Our assumption is that the site probably prioritized treatment trials,” he said.

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

Findings-Published Online Thursday JAMA network open -Based on approximately 30,000 patients who participated in US cancer trials between 2016 and February 2021.

In March and April 2020, the number of weekly clinical trial enrollments dropped significantly across the board. However, the rebound continued after that. So, in fact, by the end of summer, there were more registrants than expected during the pre-pandemic period.

According to Gralow, the study made various changes to limit patient migration and exposure to large medical centers. Sometimes it can be done by phone or virtual medical visit, but if that is not possible, the patient can do it at a local outpatient clinic, for example a blood test or imaging test.

Now, Mr. Gralow said the big question was whether some of these measures should be permanent.

“Outside the pandemic, we want to make it easier for patients to enroll in clinical trials,” she said. “Can we incorporate more flexibility into it and bring trials to patients?”

Unger agreed and said researchers needed to study the effects of pandemic changes-including whether they had somehow harmed patient care.

Another positive finding showed no signs of a sharp decline in enrollment of black and Hispanic patients in treatment trials.

Unger said this is encouraging for many reasons. Blacks and Hispanic Americans have been particularly hard hit by pandemics and have traditionally been underestimated in clinical trials.

Meanwhile, in this study, prevention-focused trials showed a decrease in all demographic groups, especially black and Hispanic patients, and women.

Researchers speculated that women may be more affected than men because of the high unemployment rate due to pandemics and the need to stay home with their children.

Gralow emphasized that clinical trials are the only way to advance treatment. Hopefully, she said the trial could make it easier for patients to participate in the future.

For more information

The National Cancer Institute Participation in clinical trials..

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