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Cancer Clinical Trial Enrollment Fell During COVID-19 Pandemic
Cancer clinical trial enrollment decreased from 150 patients per week to 109 over several weeks as COVID-19 cases increased over 22,000 during that time, a JAMA study found.
A recent study found that the COVID-19 pandemic is associated with a notable decrease in enrollment in National Cancer Institute-sponsored clinical trials for cancer treatments, especially in strongly affected coronavirus areas.
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The cohort study published in JAMA Network Open studied patient enrollment in studies conducted by the SWOG Cancer Research Network, a National Cancer Institute-sponsored National Clinical Trials Network group, between January 1 and April 25, 2020.
Enrollments were compared to the cumulative incidence of confirmed COVID-19 cases in the US.
Out of nearly 1870 patients over 11 weeks, researchers found that SWOG enrollments ranged from 125 individuals per week to 150 per week. The mean enrollment was 137 individuals.
By Week 12 – March 15th through the 21th- enrollment declined to 109 individuals. Simultaneously, COVID-19 cases rose from 2,918 to 25,697 confirmed incidences, which represented a ten-fold increase over a period of seven days.
From March 22th to the 28th until the end of the study period, weekly enrollment did not exceed 74 individuals. During this time, coronavirus cases around the country neared 1 million.
Clinical trial sites from the states with the highest number of COVID-19 cases per 100,000 individuals that enrolled in Weeks 1 to 11 were only about half as likely to enroll patients in Weeks 12 to 17, the study also found.
Researchers noted that they followed the Strengthening Reporting of Observational Studies in Epidemiology (STROBE) reporting guidelines for cohort studies. Enrollments were from trials previously approved by an institutional review board.
Enrollment to cancer control and prevention trials decreased much more than treatment trials, potentially reflecting an emphasis on offering beneficial treatments to individual patients, researchers said.
The National Cancer Institute and FDA recently issued guidance to ensure patients enrolled in clinical trials are exposed to as little risk as possible during the pandemic.
These proactive steps include allowing for remote consent and virtual telehealth visits, researchers stated. These approaches may improve the experience of trial participation for patients in the long term.
"Such measures are vitally important given the critical role government- and industry-sponsored trials play in establishing new oncology treatment options for patients,” they concluded.
Clinical trial sites are quickly becoming more concerned about COVID-19- related interruptions to clinical trial recruitment and retention, according to a March survey.
The ongoing quantitative survey conducted by Continuum Clinical uncovered that both the US and Europe are facing challenges with clinical trial sites across the board.
Specifically, US clinical trial site concerns increased from 25 percent to 47 percent over just four days, an 88 percent increase.
“We are seeing an unprecedented shift in site sentiment over a very short time frame,” Paul Ivsin, Continuum vice president of data and analytics, said in the survey. “We need to continue monitoring these trends and building fact-based planning scenarios to help sites and sponsors prepare for a period of very different patient recruitment and retention patterns.”
