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Bloomberg Law – Coronavirus Forces Cancer Trial Changes Patients Long Sought

Bloomberg Law – Coronavirus Forces Cancer Trial Changes Patients Long Sought

Rebecca Stephens last checked in with University of California San Francisco researchers running her cancer trial by video, and the coronavirus could make that routine.


The Covid-19 pandemic is forcing cancer trials to get creative, accelerating changes patient advocates have long sought to make it easier for more people to join the studies.


For patients like Stephens, who’s battling colon and liver cancer, that means she got her lab work and vital signs done by local providers in Santa Rosa, Calif., rather than making the two hour trip to San Francisco, which would require her husband or father to drive her.


Cancer centers are trying to limit the time cancer patients like Stephens, who are particularly vulnerable to infectious diseases such as Covid-19 because of their underlying health condition and because cancer treatments can suppress the immune system, spend in hospitals.


Increased telehealth options and allowing local doctors to handle routine work could go a long way toward encouraging eligible patients to join cancer trials. Currently, only 2% to 5% of adult cancer patients enroll in clinical trials. Financial and logistical reasons are listed as some of the most common barriers to enrollment and the cancers centers are often in urban areas, creating regional disparities for outlying residents who can’t regularly make the trip.


“In the rear view mirror, we may discover that the Covid‑19 response was an unintended catalyst for change, for future clinical trial protocol development, and most importantly, the reduction of the burden of participation for cancer patients,” Dana L. Dornsife, founder and CEO of the Lazarex Cancer Foundation, which helps patients with financial and other barriers to clinical trials, said.


Cancer centers like UCSF’s Helen Diller Family Comprehensive Cancer Center limit the amount of time patients spend at the clinic by cutting down visits for infusions and other procedures where they have to be there. “That’s really a radically different model for monitoring patients,” Hala Borno a medical oncologist at the center, said in an interview.


The pandemic is laying the groundwork for a world where more cancer trials are conducted virtually, easing travel and inconvenience for participants, Dornsife said.

The Food and Drug Administration recently issued guidance highlighting flexibilities for clinical trials during the Coivd-19 pandemic. The National Cancer Institute also issued guidance for researchers on how to manage their studies.


Stephens’ monthly trips usually involve several appointments with one-hour waiting periods in between. “It’s just taxing. Doing it this way, in my mind, is a really nice way,” she said. “I get you can’t do it all the time,” but she said it would be a treat to have remote care as an occasional alternative.

Highlights Ongoing Challenges

Before SARS-Cov-2, the virus that causes Covid-19, broke out, there was interest in making clinical trials more accessible to patients by having the trial closer to them, Jeff Allen, president and CEO of of Friends of Cancer Research, said.


“While all of that continues to remain true, you have a scenario here where that’s really being amplified,” he said. “Everyone still wants to not put additional burden on the patient. But when the hospitals are besieged with other cases of a highly contagious virus, for the safety of the patients, the safety of the health-care workers, and keeping space for hospitals being a key consideration, that’s adding pressure to begin to look at this.”


Challenges could arise as cancer centers ramp up remote medicine, Borno said. Some patients may be inexperienced and therefore uncomfortable with communicating digitally. Others may not be proficient in English, and researchers must ensure they are being heard clearly and accurately. Ultimately, researchers must gain trust and engage in shared decision making of their patients when they’re using these different communication platforms, she said.


“There’s a lot of things we have to think through as we use these,” Borno said. “Covid is hopefully going to lead to a radical redesign in the way that clinical researchers create their clinical trial protocols, and maybe allow clinical researchers to rethink burden in a way that they have not before.”…