1. Nolen, Lindsey

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The novel coronavirus is impacting many aspects of health care, including the administration of and access to clinical trials. While oncological research trials are designed to help progress the standard of care, the safety of cancer patients and clinicians has prompted many trials to be placed on hold, if not canceled, in the interim.

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Following the guidance put forth by multiple national agencies, Randall A. Oyer, MD, Medical Director of the Oncology Program at Penn Medicine Lancaster General Health, said oncology stakeholders are working to address the real-world operational challenges and information gaps that are currently emerging. Since becoming President of the Association of Community Cancer Centers (ACCC) in early March, Oyer announced that this year's "president's theme" is that community oncology can close the gap in cancer research. Yet, as COVID-19 has caused clinical trial delays and interruptions across the country, this theme has taken on new meaning.


Across ACCC members and their respective programs, Oyer noted the community of more than 25,000 multidisciplinary practitioners and 2,100 cancer programs is seeing a number of trends as a result of the coronavirus. These trends include clinical coordinators not being allowed on campus, all new clinical trials being halted, and some open trials having no new accruals. Additionally, some members are reporting that their research staff members have been redeployed or otherwise occupied and that clinical trials are no longer a top priority amid the growing pandemic.


"All of our clinical trials teams of physicians and nurses are [being] pulled in other directions and have decreased attention for doing so," Oyer said. "For the distraction within our clinical trials office, all of the prevention trials that we're not doing, all of the registry trials that we're not doing, all of the new trials that we're not pursuing or the meetings were having with potential sponsors, we really are buckled down to stronger focus on continuing our essential treatment trials. Those are getting done very safely with good, strong attention."


In communication with the FDA, NCI Cancer Therapy Evaluation Program (CTEP), NCI Community Oncology Research Program (NCORP), NCI Central Institutional Review Board (CIRB), corporate groups, industry sponsors and internal organizational guidance, Oyer noted the ACCC's priority remains to continue oncology treatment trials. However, the organization understands the need to pull back on prevention and registry trials, and believes that patients directly benefit from treatment trials. Thus, providing the trials remains essential.


"One thing that we've noticed is that there are new COVID-focused trials that are being accelerated," Oyer said. "New ideas and some oncology drugs, such as graft-versus-host drugs, are being repurposed and quickly turned over by institutional review boards into COVID-19-focused trials."


Also in terms of the way clinical trials in oncology are being approached, Oyer stressed that clinicians must maintain Good Clinical Practice, try to get all of the data needed, not compromise the integrity of trial or patient participants, and always consult a sponsor. Another relevant strategy is to determine alternatives for patient contact, monitoring, and drug access (i.e. video, telemedicine).


"In the course of a week, [Penn Medicine Lancaster] went from using video health or telemedicine in the oncology clinic from 0 percent to about 45 percent, and now we're well above that in our second week. Our clinical trialists are using that as well," Oyer said. "It is likely to be protocol deviation. It needs to be documented but that's certainly expected, and our monitoring is being done the same way."


Upon review of the FDA website, NCI website, talking to sponsors, reviewing cooperative oncology group documents, conversing with academic partners and to some physicians and nurses on the frontline of clinical oncology trials, Oyer emphasized that the number one priority right now is to keep patients and staff as safe as possible. He noted that Penn Medicine Lancaster General Health has three doors available to enter the facility, but that right now two of them are closed. Admittance and screening are being done at the front door only.


"We try to keep our oncology patients and clinical trials patients safe, and our staff safe as well by dividing into separate teams," Oyer said. "We've divided into A, B, and C teams where we have enough people. At the end of the day, it's still all hands on deck, we have to do what we have to do to take care of our patients."


He further identified that COVID-19 testing may be mandated, or quarantine may be mandated in an area, and that these requirements and regulations take precedence. Oyer added safety changes always come first, and ensuring the safety of study participants should remain paramount.


"I'm an oncologist, which means by nature I'm an optimist. I think we all need to take this opportunity to look forward," Oyer said.


For more information about COVID-19 and the impact on clinical trials, visit the ACCC COVID-19 resources center at


Lindsey Nolen is a contributing writer.