Professor Ian Davis. Source: ANZUP

Participation in clinical trials for oncology is beginning to return to pre-pandemic levels after major disruptions in 2020 and 2021, researchers are reporting.

Data from two large US cancer centres show the number of newly activated trials fell by a quarter (24%) between March and May 2020 compared to the previous three months. New patient accruals, a measure of trial subjects excluding withdrawals and those screened out, fell 46%.

But a year on, trials had bounced back on both measures, with new patient accruals reaching 30% higher than pre-pandemic levels by May 2021.

Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) chair Professor Ian Davis said there was probably a similar story locally, despite Australia’s relatively low COVID case numbers early in the pandemic.

This reflected the overall drop in presentations, said Professor Davis, a medical oncologist and Professor of Medicine at Monash University’s Easter Health Clinical School.

“There was a 30% reduction in the number of new prostate cancer diagnoses for example,” he said.

“People weren’t going to see their doctors, they weren’t getting PSAs done, and it was similar for melanoma.”

Maintaining staffing levels was another key issue, with some researchers either forced to take time away due to COVID-19 or redeployed to cover clinical staff in other areas.

“A lot of centres were also reluctant to take on new trials because they didn’t know what sort of resources they would have or were nervous the hospital would end up full of COVID-19 cases,” Professor Davis said.

“In my hospital in Melbourne, we had to close down wards and re-open them as dedicated COVID wards. And we had plans for opening a whole lot more in the worst case scenario.

“It was very much planning for survival mode across the health system.”

The figures from the Dana-Farber Cancer Institute in Boston and the Tisch Cancer Institute in New York showed greater falls in the number of academically-sponsored trials, rather than those funded by industry.

“This perhaps shows a better adaptation among industry sponsored clinical activities,” researchers from the two centres reported in Annals of Oncology.

“Also, academic trials can be more resource-intensive endeavours, often requiring research biopsies and more visits, which could have limited accrual.”

While there was no Australian data, there was a strong chance the same was also true locally, Professor Davis said.

“Our experience with ANZUP was we were trying to open academically-funded trials during this period and sites were coming back saying they did not have the resources,” he said,

“That probably underlying that fact was that these trials generally don’t pay as much per patient as those sponsored by industry.”

Nevertheless, he said he was proud the group had managed to open an international prostate cancer trial in Australia, even at the height of the pandemic in 2020.

“People in the US and Europe looked at us and were amazed, but we did try to keep business as usual as much as we could,” he said.

“The reason for that is we view clinical trials as a key part of quality health care, not a luxury.

“And if you look at it that way, you would no sooner stop a clinical trial than you would stop doing surgery.”

The US researchers said the lessons learned from the challenges of COVID restrictions may improve patient clinical trial access and protocol adaptability in the long term.

Many studies with strict time points for clinical examination, blood tests, and imaging were forced to deviate from protocol due to the pandemic, they noted.

“Although the impact of these changes on results remains unknown at this time, this flexibility has been viewed favourably by patients and researchers,” they said.

“In the future, it is likely that trials could be designed with more flexible timelines and reduced data collection requirements without negative consequences. Furthermore, efforts to sustain clinical trial enrolment and safely adapt research practices during the pandemic through the use of telehealth, remote monitoring, and shipment of therapeutic agents are crucial to both ensuring patient access to novel agents and to advancing clinical science.

“Measures including increased patient, physician, and trial sponsor acceptance of telehealth and postal delivery of oral experimental medications may decrease geographic barriers to clinical trial enrolment and allow greater flexibility in the setting of future disruptions,” they suggested.