By Arturo Loaiza-Bonilla, MD
Cancer doesn’t stop. So what happens when clinical trials for cancer treatments do? The question looms as the coronavirus brings trials across the country to a halt.
About one-third of Phase III clinical trials in the United States are cancer related. Because of COVID-19, few are actively enrolling. Patients who would otherwise enroll are constricted not only by lockdown orders and social distancing but by a healthy understanding of their own risk. Cancer treatment can suppress patients’ immune systems, making their bodies less able to fight off the novel coronavirus.
In some cases, patients themselves are becoming caregivers. I think of a stage 4 pancreatic cancer patient whose spouse contracted COVID-19. His role at home rapidly shifted, as he became responsible not only for his sick spouse but also for tasks like keeping the house in order, the refrigerator stocked, the house plants watered and the bills paid. Joining a clinical trial is hardly feasible in such circumstances.
These barriers compound an existing challenge. Low clinical trials enrollment and awareness already plague the medical world. Even in normal circumstances, only about 3-to-5% of patients enroll in an oncology clinical trial. Amid a pandemic, I suspect, these numbers are probably dismal.
And it’s not just enrollment issues at play. Clinical trials require strict adherence to protocol. Patients have to come to the cancer center at specific times; labs and imaging must occur at precise milestones. Schedule, procedure and precision give the trial integrity. But predictability is all but lost during the COVID-19 pandemic.
What if a patient’s caregiver gets sick and can’t accompany him or her to the trial site? What if staff at the lab or imaging center are reassigned, overwhelmed or have their hours altered under hospitals’ COVID-19 policies? As hospitals forego elective procedures to minimize COVID-19 exposure, they are feeling the financial impact. In some cases that means cutting back staff and hours.
What if trial staff themselves get sick? In the unfortunate situation where a primary investigator or member of the clinical team is infected by COVID-19, the trial can face staff shortages, or even transmission to trial participants. Both are dangerous and deeply disruptive.
Until we get a COVID-19 vaccine, there’s a strange new normal in the world of oncology clinical trials.
But there’s a positive impact too.
These challenges are forcing ongoing clinical trials to take on a new level of flexibility. I’m thinking of access to telehealth, remote assessments, getting scans and labs elsewhere and then reviewing them locally. The threat of the novel coronavirus is pushing us to think outside the box. More than ever before, I sense medical professionals working together, collaborating with renewed dedication to see that patients are taken care of. We are resolved to provide patient-centered care no matter the circumstances.
My hope during this year’s Clinical Trials Awareness Week is that, as COVID-19 barriers are lifted, we will continue to see more telehealth available, more flexibility, a more open and collaborative and digital era. This could help boost clinical trials enrollment down the road, and make sure that oncology research comes back from COVID-19 more vibrant and promising than ever.
Arturo Loaiza-Bonilla, MD, is a medical oncologist from Pennsylvania and a member of the Alliance for Patient Access.
Clinical Trials Awareness Week is a project of the Coalition for Clinical Trials Awareness. In the interest of social distancing and disease prevention, this year’s awareness week will take place through digital events and publications. Learn more at CCTAwareness.org.