Regulatory Focus - Woodcock: Post-COVID, new flexibility could boost cancer trial diversity
Though cancer clinical trials have taken a hard knock from COVID-19, preserving and extending pandemic flexibility may give oncology research broader reach than ever before, according to Janet Woodcock, MD, the acting commissioner of the US Food and Drug Administration (FDA). Woodcock spoke Friday at a webinar co-hosted by Friends of Cancer Research and the American Society of Clinical Oncology,
At the meeting, whose focus was how to improve patient access and representation in cancer clinical trials, Woodcock was asked about her most urgent goal for cancer trials in 2021. “I really believe that the most urgent thing to do is to figure out how we get research integrated into clinical practice and get started on that,” she replied.
Not for the first time, Woodcock called for cancer trialists to reach into their communities, relax exclusion criteria, and use platform trials when possible. The bulk of her remarks centered around big-picture and practical steps to increase trial accrual at the community level, an effort that stands to boost diversity in clinical trial participation along many axes.
Seeing “a call for change from multiple directions,” Woodcock said that as cancer researchers and pharmaceutical companies emerge from the pandemic, the opportunity exists to rethink the usual course of cancer trials.
Harkening back to her days leading the therapeutics side of the COVID-19 accelerator Operation Warp Speed, Woodcock spoke to the challenges of trial recruitment during the pandemic. “We had tens of thousands of people dying – and we couldn’t enroll patients, because we were relying on networks that had been stood up before…we just had a limited number of sites and we had a lot of constant competition for patients,” she said.
Clinicians and researchers recruiting patients for COVID-19 therapeutics trials faced frustration, she said: “They had community hospitals all around – affiliated with them – and they couldn’t enroll patients there, because there hadn’t been any training, and there weren’t any research personnel or study personnel.”
It’s not an “us versus them” scenario, Woodcock emphasized: “It’s not like community care is totally opposed to participation” in research; rather, the resources, training and support are currently lacking to enable smaller facilities – and, by extension, their patients – to participate in research.
FDA has been doing its part, said Woodcock, by issuing recent guidance on enrolling diverse populations in clinical trials that include everything from widening eligibility criteria to ensuring cultural and ethnic diversity – “you know, the whole ball of wax,” she said. (RELATED: FDA lays out strategies for promoting diversity in clinical trial enrollment, Regulatory Focus 09 November 2020)
Woodcock made the point that though these elements are necessary, they are not sufficient. Many practical hurdles still need to be overcome, but lessons from the pandemic may help speed the path to a 21st century approach to clinical trial conduct.
Everything from digitizing the informed consent process to enabling remote, “no-touch” visits to telemedicine and better use of the electronic medical record can help facilitate moving trial participation into communities, said Woodcock. “If we can move to those innovations we’re going to help those practitioners out in the community participate because they’re doing fewer forms. We were really impeded, and we still are, by too much trial bureaucracy.”
“We’re doing a lessons learned out of the therapeutics group that I was running at what was called [Operation] Warp Speed. It’s going to be a long list!” said Woodock. “But there are many opportunities to streamline.”
Friends of Cancer Research