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As the COVID-19 pandemic rolled across North America earlier this year, cancer clinics shut their doors, patients stayed home, and oncology researchers contemplated an unthinkable setback as laboratory closures and trial freezes threatened the demise of years of research.
“Around 1000 organizations have reported trial disruption, consistent with a reported ~80% decrease in new patients entering trials per site in April 2020 compared with April 2019,” said John Xue and his group from the management consulting firm McKinsey & Company.
Even if the trials didn’t completely stop, enrollment often slowed or substantially declined. There has since been some recovery, but today’s clinical trials do not look the same as before the pandemic: rules have been tweaked, bent, or abandoned altogether, steps have been streamlined, and red tape has been slashed.
Could it be that these sleeker, pandemic-style clinical trials represent an improvement over what we had before?
Many researchers think so.
When the American Society of Clinical Oncology surveyed its members about how COVID-19 has affected cancer care, many answered positively to questions about clinical trials.
More than 90% said telehealth visits during clinical trials were an improvement, and more than three quarters (77.4%) said that remote patient monitoring of symptoms was as well.
Remote site initiation visits and remote monitoring by sponsors/clinical research organizations were also seen positively by a strong majority (71.0% and 64.5% of respondents, respectively).
“You can expect these findings to be reflected in future guidelines,” said ASCO’s chief medical officer, Richard Schilsky, MD, and colleagues in a commentary. “ASCO already has a roadmap for conducting clinical trials going forward.”
ASCO’s Road to Recovery recommendations ― which are expected soon ― will touch on how the adaptations that have been made as a consequence of the pandemic could be used to improve clinical care and clinical trials, he said.
A leader from the pharmaceutical industry is in agreement. “COVID-19 must catalyze changes to clinical development,” wrote Rod MacKenzie, PhD, Pfizer’s chief development officer and executive vice president, in a recent commentary in Nature Reviews Drug Discovery.
“The response has already taught us what we are capable of when the chips are truly down,” MacKenzie continued. “Sponsors and regulators have been galvanized by the COVID-19 pandemic. Flexibility, boldness in capital deployment, responsiveness, parallel processing and speed in decision-making have been the hallmarks of the work to date.”
That’s true beyond the United States.
“Most [Canadian] centers have now scrutinized their prepandemic practices and incorporated novel adjustments, such as digital sign-offs and telemedicine consults,” confirmed Geoff Watson, MD, from Toronto’s Princess Margaret Cancer Center.
“Academic interactions have gone largely virtual to maintain collaborative opportunities among investigators, researchers, and sponsors when physical distancing restrictions are still in place. Protocol adaptations have also resulted in fewer travel and hospital visits for patients, for example, the collection of bloodwork locally when it is appropriate,” Watson told Medscape Medical News.
Even the basic designs of clinical trials need a dramatic overhaul, Watson and colleagues from the same center argue in an essay published in JAMA Oncology entitled, “The Day After COVID-19 — Time to Rethink Oncology Clinical Research.”
The message from the pandemic wake-up call is clear — our society can no longer accept incremental clinical trials.
“The message from the pandemic wake-up call is clear — our society can no longer accept incremental clinical trials. The scientific community must share its collective wisdom to raise the bar to conduct clinical trials that have the greatest potential to yield meaningful outcomes, supported by strong biological hypotheses and guided by validated predictive biomarkers,” they write.
“Poorly designed clinical trials unlikely to address clinically meaningful hypotheses should be discouraged,” coauthor Daniel Araujo, MD, told Medscape Medical News.
“These changes should come from all stakeholders engaged in clinical research, including but not limited to investigators, sponsors, regulatory bodies, and patients,” added coauthor Lillian Siu, MD.
As the pandemic grinds on, with some trial sites now mired in an ominous-looking second wave, these calls for clinical trial improvement are becoming louder. But will these commitment to change remain when the virus is gone?
There’s no reason why not, says Clifford Hudis, MD, ASCO’s chief executive officer.
“For example, if, in the face of the pandemic, it became possible for sponsors to ship drugs to pharmacies or directly to patients, you have to ask why that can’t be a permanent efficiency,” he told Medscape Medical News.
“Or if we decided in April that telemedicine was safe and effective for patients, why would we ever decide later that it’s not safe and effective as the COVID pandemic fades? I’m not saying it’s the only way to give care, but our flexibility around that is something we might want to preserve,” he added.
Schisky and Hudis have disclosed no relevant financial relationships. Watson has received travel grants from Bristol-Myers Squibb and AbbVie and honoraria from Pfizer. Araujo has received honoraria from GlaxoSmithKline. Siu received compensation in 2020 from many pharmaceutical companies and her spouse is a stockholder in Agios Pharmaceuticals and the cofounder of Treadwell Therapeutics.
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