This drop was followed by an initial recovery period lasting through the summer of 2020; in fact, by the end of the summer, enrolment totals actually slightly exceeded what would have been expected without the pandemic.

Enrolments again dropped during the wave of increasing COVID-19 infections in the winter of 2020/2021, but very slightly compared to the initial wave of the pandemic.

To assess changes in trial registration rates, investigators used interrupted time-series analysis to compare pandemic enrolment rates to expected rates based on data from the four previous years.

A total of 29,398 patients were enrolled to SWOG trials from January 1, 2016, through February 28, 2021. About two-thirds of these enrolments were to treatment trials, with the remaining one-third to cancer control and prevention studies.

Unger explained that early in the pandemic, the NCI and Food and U.S. Drug Administration had provided guidance allowing research sites more flexibility in enrolling and following patients on trials. Key recommendations included allowing remote consent of patients and virtual visits.

Overall, during the entire one-year pandemic period measured (March 2020 through February 2021), SWOG trials enrolled 5,344 participants, whereas an estimated 6,913 participants would have been enrolled had the pandemic not occurred.

Particularly steep drops in enrolment were seen within cancer control and prevention studies, which registered only 54 percent of expected enrolments, while enrolment overall to treatment studies was 91 percent of expected.

These findings show that the steps taken to maintain trial research programs were successful. It is a testament to the resiliency and resourcefulness of the physicians, nurses, and staffs at the sites.

The researchers guess that the maintenance of near-normal overall enrolment levels to treatment trials over the course of the pandemic may have occurred at the expense of support for cancer control and prevention trials.

The authors also assessed relative changes in enrolment by patient age, sex, race, ethnicity, and state of residence. Enrolments dropped substantially in states hit harder by the pandemic, but overall enrolment numbers remained relatively unchanged in less hard-hit states.

Enrolments of Black and Hispanic patients to treatment trials did not fall significantly over the pandemic year. In contrast, cancer control trials saw reductions in enrolments for all demographic groups of patients, especially for Black and Hispanic patients.

Researchers also observed that the decline in the enrolment of female patients to cancer control and prevention trials was notably greater than it was for male patients.

These findings also indicate that the question of whether enrolment overall remained significantly reduced is an important one, because long-term drops in clinical trial can slow the development of new therapies for all cancer patients.

Source: Medindia