Enrollment and screening for cancer clinical trials have largely come to a standstill amid the SARS-CoV-2 outbreak, but oncologists and others are mapping a way forward and remote monitoring and visits are emerging as a common thread to resume therapeutic research while maintaining patient safety.
When the COVID-19 outbreak started in the US, medical centers across the country took swift action to reduce nonessential visits to hospitals, research facilities and clinics, resulting in the suspension of visits for clinical trials.
According to the American Association for Cancer Research (AACR), a recent study showed that cancer patients could be more susceptible to severe outcomes due to COVID-19, the illness caused by SARS-CoV-2. Results published on April 23 showed that 105 cancer patients infected with SARS-CoV-2 had higher rates of death, ICU admission and at least one severe critical symptom when compared with age-matched patients also infected with the virus.
While avoiding exposure to the virus is important, oncologists have voiced concern about possible negative consequences of the outbreak for some cancer patients for whom participation in a clinical trial may be the only opportunity for treatment.
According to a survey by the American Society of Clinical Oncology (ASCO), nearly 60% of research programs have reported halting screening or enrollment into cancer clinical trials. However, oncologists and trial sponsors are turning to digital methods to help connect patients to studies.
Two-thirds of the 32 institutions that responded said they were using remote visits to replace clinical trial visits, but they also had challenges in organizing, implementing and conducting telehealth. In cases where sites were permitting visits, patients were unable or unwilling to come to the site and that there was limited availability of “radiology, surgery, cardiology and other ancillary services that are essential for some clinical trials,” according to ASCO.
As a result, ASCO has started a Road to Recovery initiative to chart a course for “returning to a new ‘normal.’” The project will include two multistakeholder groups—one focused on research and the other on care delivery—to evaluate how practice changes in these areas due to COVID-19 could inform new approaches to cancer care and research. The groups will produce recommendations by September.
“The pandemic has led to several far-reaching federal, state, institutional and practice-level changes in process and policy,” the group wrote. “It is important to understand their impact and to identify whether and how modifications made to care delivery and research during an emergency could be adopted as new standard practices to support safer, more effective, and higher quality care and research in the future.”
The Clinical Trials Transformation Initiative (CTTI), a public-private partnership, has also started to put together best practices for clinical trials regardless of disease focus and is incorporating the new FDA guidance that has been issued related to the conduct of trials during COVID-19.
The group published an initial list of seven best practices on April 14 and said it will update the document regularly based on findings from its surveys and webinars. Switching to remote patient monitoring and pivoting to remote study visits are among the initial best practices highlighted by CTTI.
HRI impact analysis
Cancer studies make up a large proportion of clinical trials, and a move to virtual trials for this cohort of patients could be the start of a bigger shift as trial sponsors and researchers attempt to balance keeping patients safe from infection and giving them access to potentially beneficial new therapies.
As of Tuesday, cancer clinical trials account for 22% of the trials listed at ClinicalTrials.gov. An HRI analysis found that over half of the trials are in Phase I (16,474) or Phase II (26,977). However, only 104 of the 74,214 total cancer trials had been suspended between March 1 and 31.
As physician groups like ASCO begin to transition to virtual visits with clinical trials during the pandemic, HRI’s consumer survey found that consumers have started to access telehealth in greater numbers as well to manage chronic conditions and other health concerns.
PwC’s partners have highlighted that companies and institutions that embrace this transition to remote visits could emerge stronger and better prepared for the changing healthcare ecosystem. On the commercial side, companies are starting to shift to remote territory management, while on the R&D side some pharmaceutical and life sciences companies are starting to accelerate trial virtualization.