publication date: May. 8, 2020
With the COVID-19 pandemic, the cancer clinical trials—they are a-changing
Gregory Masters, MD
PI, NCORP grant;
Lung cancer specialist, Helen F. Graham Cancer Center and Research Institute,
Associate professor, Thomas Jefferson University Medical School
Nicholas Petrelli, MD
Bank of America endowed medical director,
Helen F. Graham Cancer Center and Research Institute,
Kandie Dempsey, DBA, MS, RN, OCN
Director, Cancer Research,
Helen F. Graham Cancer Center & Research Institute,
This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.
Prior to the COVID-19 pandemic, NCI estimated that about 3% to 5% of adult cancer patients participated in clinical trials.
The reasons for this low accrual rate have been discussed and debated ad nauseam, with a lot of energy and resources devoted to improving adult clinical trial participation. Efforts to increase accrual have included more lenient entry criteria, a more robust support staff to identify eligible patients, and resources for physicians and caregivers to set aside time needed to make these studies available to their patients.
Patients enrolled on clinical trials often receive equivalent or better care, perhaps due to the standardization of care and close monitoring, even on standard arms of these studies.
Programs such as the NCI Clinical Oncology Research Program, or NCORP, provide resources to support the time and effort needed to enroll patients on clinical cancer trials.
But the current coronavirus pandemic has interrupted this program, too. In addition to the tragic toll this disease is taking on the general population, it had also led to a 44% decline in cooperative group trial accrual as of early April, according to an NCI communication.
At the Helen F. Graham Cancer Center & Research Institute, various programs and policies have been implemented to support accrual to NCORP trials, and strong institutional support has allowed our accrual rate to rise over the last 15 years to 20% or more—prior to the pandemic.
But what can we do now with new barriers to enrollment imposed by the COVID-19 pandemic?
Patients express fear of coming in for evaluation, tests and treatments due to the risk of infection. They have heard the message: stay home if you want to stay safe.
But for cancer patients embarking on a treacherous path back to health, these lost visits can mean fewer opportunities to understand their options to participate in trials, to get the needed testing to become eligible, and to receive the therapeutic interventions they need.
Recent data from the Alliance for Clinical Trials in Oncology suggests that clinical trial enrollment may be down 40% to 60% across the country due to these new, unique challenges. Patients are often seen by telemedicine, and that may make it more difficult to fully explain the clinical trial and its implications, and to give patients fully informed consent.
Many of our patients cannot or will not come to the office, and it is therefore more difficult to identify appropriate clinical trials for that population.
Clinicians at our institution are burdened with new guidelines and distractions as well as the increased stress of dealing with personal and family health issues and concerns. This may take their attention away from the extra effort often required to enroll patients on a clinical trial.
One complicating factor is many of our nurses are working from home, leading to a decrease in personnel power available at the point of care. We all have some component of excess anxiety, fear, and even complaints of burnout with these new stresses during the pandemic.
We also have to deal with the concern about patient safety if they enroll on a clinical trial and may need additional visits, scans, labs, thereby increasing potential exposure to COVID-19 infection.
Fewer patients are being seen due to a decrease in screening testing, surgical biopsies, and patients going to their primary care physicians to follow-up on routine complaints.
There may be delays in the required testing to enroll in a clinical trial including labs, scans and molecular testing results. This can make it more challenging to get all the required criteria completed for clinical trial eligibility.
At the Helen F. Graham Cancer Center & Research Institute, we focus on a collaborative approach to identify appropriate patients for clinical trials, and a systematic process to encourage enrollment when appropriate.
This has led to a team effort amongst the three disciplines, including surgery, radiation and medical /hematologic oncology, with multidisciplinary disease site teams that include research trial nurses. With this approach, along with continuing to activate new trials and supporting our affiliate institutions, we have noticed a favorable trend to maintaining our high accrual in the last two months during the COVID-19 pandemic.
While some institutions have placed clinical trials on hold, at our institution there remains strong support for enrollment. Maybe we see this as a collective challenge to beat this invisible foe. Our research nurses are actively assessing eligibility, helping to identify new patients. The current pandemic offers an opportunity to face these challenges head-on and continue to improve an imperfect system.
We can work to identify the blockades to optimal patient care, including barriers to enrolling patients on clinical trials at our institutions, and move forward with improved ways to screen for eligible patients, and identify the most appropriate treatment approaches, especially as part of a clinical trial.
With fewer patients coming into the office, we may be able to spend more time explaining the value of clinical trials for their situation, and how their participation is good for them and others in their community. We have found that many patients want to know how they can contribute—and participating in a clinical trial is one such opportunity.
With the option of telemedicine, we may be able to divide information sessions into visits with shorter encounters that may not be as overwhelming to patients. Several discrete conversations may increase the chance to fully explain the value of clinical trial participation. We can harness our collective wisdom and experience to take advantage of the crisis, and rethink how to make the system better.
Yes, there are devastating losses with this international health crisis, but let us not miss a chance to serve our patients, and use clinical trials to move medicine forward for our current and future patients.
At our cancer center, we did not stop clinical research, but saw a challenge that has led to a favorable trend to a sustained high clinical trial accrual. We now talk about eventually getting back to a new normal.
From what we have learned from COVID-19, that new normal should lead all of us to reducing barriers to clinical trial participation and increasing clinical trial accrual.