Columbus-based Ohio State University Comprehensive Cancer Center–The James researchers are preparing to launch a first-of-its-kind cancer clinical trial for a "smart drug" over telehealth.
The virtual trial will utilize a drug that targets the gene that causes fibroblast growth factor receptors to mutate in people with pancreatic cancer. Patients will be shipped an oral drug, which has already been approved by the FDA for liver cancer, participate in regular telehealth visits with the researchers, but do all their normal follow-up care and tests, such as blood work and CAT scans, with their local oncologists, Sameek Roychowdhury, MD, a medical oncologist at The James and lead researcher, told Becker's.
"There's a lot of inertia to go back to the way trials used to be as the COVID-19 pandemic has ended," Dr. Roychowdhury said. "We're trying to fight that inertia. We learned how to do [virtual trials]. Why can't we still do it?"
Dr. Roychowdhury said he and his team were inspired by patients during the COVID-19 pandemic to spearhead this change in trial operation.
"In the first days of the pandemic, we had a patient who reached out to us because she had a gene that matched our trial, and we needed to find a way to offer it to her," he said. "For the first six weeks of the clinical trial [which was a basket trial for another oral FGFR inhibitor] she participated all by telehealth. The first time I met her, we were like, 'hey, it's you,' and we gave each other a hug. She did well on that treatment for over two and a half years. That experience stuck with me. I realized that [virtual trials] are feasible, and we were allowed to do that in an emergency situation. But it made many of us start to think, 'maybe we should be doing it on purpose.'"
For trials of specific cancers, such as pancreatic cancer with a FGFR mutation that occurs in roughly 0.5 percent of patients, telehealth not only reduces costs, but it can give access to patients regardless of location. "It can help advance this idea of individualized, personalized cancer therapy based on your cancer," Dr. Roychowdhury said.
Although telehealth trials are virtually unheard of now, Dr. Roychowdhury said they may have an important part to play in the future of clinical trials.
"I think [our trial] is a good place to start for a prototype, but as we evolve and gain experience this question is going to be important: What things are appropriate for a telehealth enabled clinical trial? We'll learn as we go. There may be certain treatments that might not be ready for that, but I'm looking forward to that challenge."
Dr. Roychowdhury's trial is expected to open by the end of the year. He said they are currently accepting referrals on their registry. He encourages all patients to get genetic testing to see whether smart drug trials may help them.