The health risks posed by SARS-CoV-2 to cancer patients have spurred changes in how cancer clinical trials are being conducted. Some of the alterations introduced by the National Cancer Institute (NCI) include using telemedicine visits, switching to electronic signatures for signing patient consent forms, shipping of oral medications to patients,1 and allowing researchers to skip collecting certain data. While the modifications may help to expand access to trials and lead to greater economic and geographic diversity of trial populations, they may also limit the amount of key information about the patient experience. Meanwhile, the pandemic itself may dissuade some groups of patients from enrolling in new trials altogether, thus negatively impacting the make-up of trial populations.
Like all other experts interviewed for this story, Hala Borno, MD, assistant clinical professor in the genitourinary oncology program at the University of California, San Francisco, was in favor of the changes that improved patient access to trials, such as the greater use of telemedicine. “In the context of a pandemic, there’s an opportunity to rethink the burdens that we place on patients and an opportunity to redesign the way in which we deliver cancer treatment in the context of the clinical trial,” Dr Borno said.
Dr Borno’s previous research showed that access to clinical trials was particularly challenging for disadvantaged social groups.2 Her 2018 study found that patients from lower‐income areas had to travel longer distances compared with patients from higher‐income areas to participate in cancer clinical trials. “What I observed is that patients coming from low-income neighborhoods are shouldering the largest burden of travel in order to participate in clinical research,” she said.
But the new measures may also lead to missing key information that is normally recorded during trials when they are conducted in person. Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, D.C., noted potential complications with capturing the patient experience via videoconferencing compared to in-person visits. For example, it might be more difficult for researchers to notice potentially concerning symptoms that would otherwise be easy to see. “For example, if, as a doctor or researcher, I’m meeting with a patient in person, I might notice that they’re slumping in their chair or they look pale or they seem uncomfortable,” she said. “I might notice a lot of things about them that won’t necessarily be so obvious in a telehealth visit.”
Problems like bad lighting in a patient’s home may contribute to visibility issues. Children bursting into the room or a dog jumping on a patient’s lap may distract the patient from the purpose of the virtual visit. Finally, Dr Zuckerman wondered whether patients might not be as candid during online appointments as they would be during face-to-face visits about how they really feel while receiving treatment.
Jonathan Kimmelman, PhD, a professor and director of the biomedical ethics unit at McGill University in Montreal, said he wondered whether the decreased frequency of in-person interactions between patients and investigators might affect detection of adverse events. “I would imagine you’re probably going to pick up more adverse events if there are more frequent interactions, and if there’s more of face-to-face interaction,” he said. Similarly, the less frequent visits may contribute to loss of information on events of progression that might occur in between visits, he noted.