COVID-19 Slows Oncology Trial Enrollment Early But Rebounds Over Time

As a result of the COVID-19 pandemic, the northeastern US felt disruptions in oncology clinical trial enrollment because of delayed diagnoses and delayed therapy. Such disruptions also disproportionately affected the diversity of patients within the trials.¹

From December 2019 to June 2021, the Dana-Farber Cancer Institute, in Boston, Massachusetts, and the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai in New York, New York, enrolled a total of 4756 new patients in their institution-wide cohort to oncology trials. Investigators noticed a large decrease of 46% in new patient accruals early in the pandemic. This decrease was followed by a recovery and even an increase of 2.6% above the pre-pandemic levels. Investigators noted that this similar to what was seen in 467 newly activated trials from June 2019 to June 2021 with a 23.6% decrease followed by a 30.4% increase. Declines in new accruals affected academically sponsored trials more than industry-sponsored trials (P < .05).

Two cohorts were evaluated: an institution-wide cohort of all new patients and a smaller manually curated cohort which was linked to an electronic data capture platform. The institution-wide cohort included all new patients in oncological clinical trials at the 2 institutions, and the curated cohort included adult patients with current or past history of malignancy who had an outpatient medical oncology visit between March 2 and March 6, 2020, at Dana-Farber Cancer Institute or Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai.

The primary end point of this study was to assess enrollment and accrual to oncologic clinical trials. Secondary end points included changes in patient- and trial-related characteristics and incidence of trial deviations and serious adverse events (SAEs).

In the manually curated cohort (n = 2361),non-White patients were more likely to be taken off trial in the early pandemic period (March-May 2020; adjusted odds ratio: 2.60; 95% CI, 1.00-6.63).

After May of 2020, 40 patients deviated from trial: 32 were minor and related to the pandemic, 2 were major and related to the pandemic, and 6 were minor and not related to the pandemic. During the baseline period, investigators recorded only 9 deviations for the same patients (P < .001). Investigators found that SAEs were not more frequent (P = 0.117) during the pandemic period. There were 6 SAEs, 2 were pandemic related vs 1 non-pandemic related SAE recorded during the baseline period.

Patients in the institution-wide cohort had a mean age of 58.2 years (standard deviation [SD] 16.1 years]. Among the newly enrolled patients from Dana-Farber Cancer Institute (n = 4071), 3579 (87.9%) were White, 118 (2.9%) were Black, 123 (3.0%) were Hispanic or Latino, and 141 (3.5%) were Asian. Most patients newly enrolled at Dana-Farber Cancer Institute had hematologic (n = 944), breast (n = 714), or other solid tumor (n = 750) cancer types.

In the manually curated cohort, the mean age was 64.2 years (SD 13.1 years), and 46.0% (n = 1086) were female. Patients in this cohort were mostly White (n = 1342, 63.8%), 299 (14.2%) were Black, 297 (14.1%) were Hispanic, and the rest identified as other non-White (n = 167, 7.9%). Covid-19 diagnoses were found in 128 patients (5.5%) at a median follow-up of 85 days (95% CI, 82-84).

At the Dana-Farber Cancer Institute and Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, clinical trial disruptions were observed early in the pandemic compared with later. Enrollment gradually recovered over time. Academically sponsored trials experienced a greater decline compared with industry-sponsored trials, and there was evidence of racial disparities among patients taken off trial.

_REFERENCE

_{Bakouny Z, Labaki C, S. Bhalla S, et al.Oncology clinical trial disruption during the COVID-19 pandemic: a COVID-19 and cancer outcomes study. Annals of Oncology. Published June 14, 2022. doi:10.1016/j.annonc.2022.04.071}