By Clinical Research News Staff 

July 21, 2022 | In a recent article published online in Annals of Oncology, a clinical team at Dana Farber Cancer Institute and Mount Sinai explored oncology clinical trial disruption during the COVID-19 pandemic. They found that substantial disruptions early in the pandemic gradually recovered, but some lasting changes remain.  

The study team looked at clinical trial activity at Dana-Farber Cancer Institute in Boston and the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai in New York—two large, Northeastern cancer centers. They considered two cohorts: an institution-wide cohort of all new patient accruals to oncology trials between December 2019 and June 2021, and a manually-curated cohort of existing patients with current or past malignancy and an oncology appointment the first week of March, 2020.   

The larger, institution-wide cohort counted clinical trial enrollment, retention, and disruption across all oncology trials at the two cancer institutes, comparing numbers for the pre-pandemic period of December 2019 to February 2020 to pandemic periods from March 2020 to June 2021. In total, from December 2019 to June 2021, 4,756 new patients enrolled in a clinical trial.  

Within that period, the researchers saw a “considerable decrease” in the numbers of newly enrolled patients between the pre-pandemic period of December 2019 to February 2020 and the first pandemic period: March to May 2020. Enrollment fell nearly 50% immediately, then enjoyed a “progressive recovery” over the rest of the pandemic back to normal levels by May 2021.  

It’s clear that sites were learning and adjusting. During the most severe peak of the pandemic—from December 2020 to February 2021—enrollment rates didn’t suffer as badly as they did in the first pandemic period. “Academic institutions were able to respond to these unprecedented circumstances, progressively adapting their systems accordingly,” the authors note.  

Trail Disruptions 

The manual cohort included patients with current or past malignancies, and before the pandemic began 269 of those were in a clinical trial. Only 29 patients from the manual cohort were newly enrolled during the pandemic, a decrease from the three months pre-pandemic, and 34 patients already in trials were taken off trial during the first pandemic period. While about half of those were due to disease progression, the authors note that, “non-white patients tended to be more likely to be taken off trial during the first pandemic period compared with white patients.”   

In addition to enrollment disruptions, trials saw record protocol deviations during the pandemic periods as well. 40 patients had trial deviations recorded—34 were pandemic-related—a significant rise from 9 trial deviations in the pre-pandemic period. The authors point out that these trial deviations not only impact the data gathered during the trial, but represent “increased administrative workload” for sites as well.   

The makeup of the trials themselves also changed. “When evaluating clinical trials according to sponsor type (i.e. academic versus industry versus government sponsored trials) among newly enrolled patients at DFCI, there was a statistically significant increase in the proportion of new patients enrolled to industry sponsored trials between the pre-pandemic period,” and the post-pandemic periods, the authors write. Academic trials fared the worst, showing a “significant decrease in the proportion of new patients enrolled to academically sponsored trials,” they observe.  

“This perhaps shows a better adaptation among industry sponsored clinical activities,” the authors posit. “Also, academic trials can be more resource-intensive endeavors, often requiring research biopsies and more visits, which could have limited accrual.”  

Newly activated trials—of all three types—saw the same steep drop off in the March to May 2020 period as enrollment, then gradually recovered, reaching levels higher than before the pandemic by June 2021.  

Racial Questions 

The authors saw no statistically significant shifts in the racial distribution of newly enrolled patients or in the age range of newly enrolled patients during any of the time periods. But in the manually curated cohort, non-white patients were more likely than white to be taken off trial during the first pandemic period. 

“The differences in clinical trial enrollment during the pandemic based on race warrants further investigation, though this finding aligns with prior studies suggesting significant racial disparities in care during the time,” the authors write.