Published on February 17, 2021
The Effect of COVID-19 on Clinical Trials for Cancer
A 60% decrease in new clinical trials for cancer drugs and biological therapies suggests that COVID-19 may be associated with long-term indirect effects on cancer mortality, according to the authors of a study that was recently published in JAMA Network Open.
The results raise concerns about the development of new cancer therapies, “to the extent that the findings are generalizable to other conditions, [affecting] the momentum of scientific progress for other disease areas as well,” the authors noted. It also adds to research on the direct impact of COVID-19 on cancer mortality resulting from infection of the novel coronavirus, disrupted treatment and delayed screenings.
Fewer Clinical Trials Were Started During the Coronavirus Pandemic
Using information from the Medidata Enterprise Data Store, researchers from Acorn AI, a Medidata Company, Johns Hopkins Bloomberg School of Public Health and Johns Hopkins Medicine aggregated all phase I through IV oncology trials of drugs or biological agents that launched during the eight consecutive months of October through May over five successive years (i.e., 40 months). The five months from January 2020 through May 2020 were considered the pandemic period, and the 35 months preceding January 2020 were considered the pre-pandemic period.
During the 40 months of observation, 1,440 phase I through phase IV oncology trials were launched in 91 countries. Of those, 1,249 were started in the years before the pandemic, but just 191 were started since the COVID-19 pandemic began. The findings reinforce the logistical challenges reported by several organizations in keeping existing trials running during COVID-19.
Impact of COVID-19 on Existing Clinical Trials
In March 2020, the American Society of Clinical Oncology (ASCO) conducted a survey to learn about the types of changes and challenges that clinical trial programs were experiencing early in the pandemic.
Most of the respondents reported conducting remote patient care when possible and remote visits and monitoring with sponsors and/or contract research organizations (CROs). However, numerous challenges were reported, including enrollment and protocol adherence difficulties with decreased patient visits, staffing constraints and limited availability of ancillary services.
“It is not surprising to see a decline in the launch of new trials,” said Dr. Richard Schilsky, chief medical officer for ASCO, in a piece for The Lancet Oncology about the recent study. “It is consistent with other work showing a 50% decline in enrollment during the early months of the pandemic.”
In December 2020, ASCO published Road to Recovery Report: Learning From the COVID-19 Experience to Improve Clinical Research and Cancer Care with recommendations for clinical research around five goals: (1) ensure that clinical research is accessible, affordable and equitable; (2) design more pragmatic and efficient clinical trials; (3) minimize administrative and regulatory burdens on research sites; (4) recruit, retain and support a well-trained clinical research workforce; and (5) promote appropriate oversight and review of clinical trial conduct and results.
“The COVID-19 pandemic quickly and dramatically transformed the conduct of clinical research,” the report stated. “Early disruptions in care delivery, demands on staff time and a necessary focus on protecting patients and care teams initially led many pharmaceutical companies to halt or delay trials without consideration for where patients were in the screening process or geographic differences in the incidence of COVID-19. This resulted in a steep fall in enrollment.”
The organization noted that there have been positive changes as a result of the pandemic, such as facilitating patient participation in research through telehealth, allowing the delivery of research-related care at clinical sites remote from research centers and closer to participants' homes and increasing flexibility in protocol requirements. The interactions of sponsors and CROs with research sites became more efficient via remote visits and monitoring and use of electronic signatures and documentation.
In addition, regulators, government agencies and journals streamlined research oversight and review to allow for rapid implementation of research studies and dissemination of emerging and important information related to COVID-19, according to ASCO.
Dr. Schilsky told The Lancet Oncology that, anecdotally, recruitment to trials has started to recover as sites adapt to new ways of working, even as cases have spiked again in many countries, including the United States and across Europe.
“This pandemic will come to an end and when it does, cancer will still be with us,” he said. “We had to redirect our focus, it had to be done, but we have to get cancer research back on track as soon as possible.”
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