Every four weeks for the last two years, Dan Greene and his wife drive 10 hours from their home in Wilmington, N.C., to the Ohio State University Comprehensive Cancer Center in Columbus so he can participate in a clinical trial.
The drive is taxing, but Greene said the trial has been the only effective treatment for his stomach cancer. He's been symptom-free since he enrolled in November 2018.
When COVID-19 struck in March, clinical trials across the country moved to telemedicine. Suddenly, instead of making the long trek to the Midwest, Greene was able to get all his labs, cat scans and electrocardiogram tests needed for the trial done near his home. His medication was mailed to him. And every four weeks he spoke with his oncologist Dr. Sameek Roychowdhury over video to go over his tests and ensure he's feeling OK.
Greene loved it. The arrangement lasted about three months. Then, policy changed, requiring Greene to get his CT scan completed every eight weeks at the cancer center in Ohio along with an in-person visit with Roychowdhury.
The National Cancer Institute funds the trial and the Food and Drug Administration approved the drug so both entities oversee the trial. During the coronavirus pandemic, the National Cancer Institute has been determining if a trial can transition to telemedicine and for how long. The FDA also issued guidance on the use of telemedicine in trials that use its approved drugs. Insurance companies and cancer centers also play a role in determining if telemedicine is part of the trial.
With COVID-19 cases still surging across the country and some recent health issues, Greene said he dreads the long drive. "During normal times, it's hard. During COVID, it's not only difficult but it's dangerous," he said.
Roychowdhury is now advocating for clinical trials going forward to have telemedicine baked in. "We have learned we can do this," he said. "We are trying to write new clinical trials that allow us to deliver a therapy to a patient by telemedicine."
Oncologists at other cancer centers also see a place for telemedicine in cancer clinical trials post-COVID. A May 2020 survey from the American Society of Clinical Oncology of 32 cancer research programs found 90.3% said telehealth visits was a potential improvement to clinical trials.
Transitioning some aspects of cancer clinical trials to telemedicine will open potentially lifesaving treatment options to more people and encourage more enrollment, according to oncologists. Its estimated that less than 5% of adult cancer patients enroll in clinical trials although 70% of Americans say they are willing to participate.
A major barrier to participating in clinical trials is difficulty with committing to the required appointments and tests needed to participate. Furthermore, some clinical trials are only sponsored at one or a handful of cancer centers in the nation. For people like Greene, that means traveling hours in order to participate, which isn't feasible for everyone.
With telemedicine part of a clinical trial it will be easier for people to participate because the number of in-person visits required can be reduced, said Dr. Paul Sabbatini, deputy physician-in-chief for clinical research at Memorial Sloan Kettering Cancer Center in New York.
"When you tell a patient, 'You don't have to come in twice a month, you can come in once a month, it opens up opportunities,'" he said.
Small trials for rare cancers may be more successful if telemedicine is applied, added Roychowdhury. Some treatments using precision medicine are for rare cancers that afflict a small population. A pharmaceutical company isn't likely to approve the trial at all or at many cancer centers because it's not financially advantageous for them. By using telemedicine, Roychowdhury said patients from across the country can get enrolled in a trial at one cancer site because they can see their provider routinely virtually.
"Telemedicine can create opportunities to bring novel therapies from pharma to these patients and overcome these barriers that institutions and pharma companies have," he said.
But there are caveats to the argument for telemedicine. Clinical trials can never be fully remote because most usually require routine physical examinations and tests to check how the patient is responding to the therapy, said Dr. Sandip Patel, experimental therapeutics deputy director at UC San Diego. "For cancer patients, telemedicine is more of a side dish than the main dish," he added.
Oncologists also gather important information from patients during an in-person visit they can't get during a telehealth visit, added Dr. Richard Schilsky, chief medical officer of ASCO. An experienced oncologist can usually tell when examining patients' mannerisms or physical appearance how they are doing, which is hard to accomplish during a virtual or telephone visit, he said.
Virtual visits also probably make most sense for patients with minimal or no side effects from the experimental drug, Sabbatini said. For those experiencing worsening symptoms, an in-person visit is probably needed.
"Telemedicine doesn't cut it for most of my patients" due to complications, Patel added.
Furthermore, oral medications are easier to transition to telemedicine. The medications can be easily shipped to the patient's home. But some clinical trials involve intravenous drugs, which likely need to be administered by a health professional, and therefore make telemedicine visits less likely.
"We don't want to start creating disparities of oral versus IV medications," Patel said. "It's not (the patient's) choice how complicated their treatment is."
There is the digital divide to consider as well. While most of his patients responded favorably to the virtual visits, Sabbatini said those who had issues with technology still prefer to come in.
Despite the current challenges, Roychowdhury said he and colleagues at other cancer centers are exploring how to include elements of telemedicine of clinical trials going forward because of its potential to create more access to patients.
"Telemedicine has a role and a place," he said.
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Cancer centers see a bigger role for telemedicine in clinical trials - Modern Healthcare
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