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Clinical trials often represent a last-ditch lifeline for patients with cancer who have run out of other treatment options, so the closure of many trials during the pandemic has come as a desperate disappointment for many of them.
But one center has managed to continue despite the pandemic. Nearly all (95%) of the therapeutic clinical trials offered by the Holden Comprehensive Cancer Center (HCCC) at the University of Iowa are still up and running.
"COVID-19 to me was a brush fire — it was coming at us very fast, and I needed to make a decision — do we stay in the house or do we leave," oncology section chief Mohammed Milhem, MBBS, who is associate director for clinical research at HCCC, told Medscape Medical News.
"I decided that I was going to keep as many new trials that were necessary open and once we had our vision to keep our trials open, everybody went to the task," he added.
It's an unusual achievement, as the COVID-19 pandemic has "caused an unprecedented disruption throughout the cancer research community, shuttering many labs and slowing down cancer clinical trial operations," Ned Sharpless, MD, director of the National Cancer Institute noted recently. Globally, more than 200 cancer clinical trials have been suspended.
Vital Resource for Patients With Cancer
As the only cancer center in Iowa, the HCCC is a vital resource for patients who have no further treatment options.
Some 5% of the center's sponsors did want their trials closed, which the clinical research team did immediately.
Nevertheless, the HCCC still has about 200 ongoing trials — trials that represent a ray of hope for patients whose malignancy is no longer responding to currently available treatments.
"As a scientist, I truly want to find something that helps someone and I feel the whole team believes that they are helping — that offering something is valuable not only from a personal perspective but that we're offering something so patients won't lose hope," Milhem observed.
Streamlining Clinical Research
That decision to continue clinical trials didn't happen in a vacuum. Already from the time of his appointment at the HCCC in 2016, Milhem was well into his goal of revamping the University of Iowa's phase 1 and phase 2 clinical trials program. He was winnowing out all trials that were judged to be nonessential, keeping only those trials going in therapeutic spaces where there were no good treatment options for patients with advanced cancer.
Slowly and systematically, the center's clinical trials team were finding ways of making the research and their resources more efficient to better serve their patients, he explained.
"Then COVID-19 hit," Milhem said, mandating even greater efficiencies and creative use of resources to ensure that patients always had at least another treatment option.
First, members of the clinical research team sat down and came up with a way of streamlining the clinical trials available so that the same rules applied to all of them.
"For example, if a patient was just coming in for a pharmacokinetic study, we eliminated that," Milhem explained.
The HCCC team also consulted with the US Food and Drug Administration, the American Society of Clinical Oncology, and the trial sponsors, "so there was some forgiveness in not following protocols to the letter," he noted.
Of course, the clinical research team did have to come up with standard operating procedures for each of the trials they were running, but once procedures were in place and all players on board, the teams were able to proceed smoothly, he said.
The HCCC had a few unique features that allowed the center to keep their trials open — and patients and staff safe — during the pandemic.
Firstly, most hospitals in the US are built tall, Milhem pointed out.
"Iowa is a horizontal hospital," he observed, meaning that the cancer center is in one small spot at the end of the hospital where all of its adjunctive services, including the clinical trial core, are close by.
This means that patients can wait in their cars outside the cancer center until they are called in, come directly to the waiting room, and be put into an examination room immediately.
In so doing, "patients are not exposed to other parts of the hospital or even to different groups of people," Milhem noted.
Moreover, the chemotherapy center at HCCC contains about 70 unique pods and pods are spaced 12 to 15 feet apart.
The pod also has walls and providers can pull a curtain around it as well, "so it's very spacious and easy to do," Milhem said.
Each nurse takes care of only about two pods at a time so patients aren't exposed to several staff while they receive their infusions.
As for staff shortages, there actually weren't any because of the way the clinical trials program at the HCCC is structured, he commented.
"There are actually two parts of the clinical research program — a translational group that does all the biospecimen stuff and the clinical trials core that takes care of patients who are on the clinical trials," Milhem said.
At the start of the COVID-19 crisis, "The translational part of the program was completely shut down, so we declared biospecimen research to be nonessential and by doing that, half of the staff actually went home," he added.
Not that they remained idle at home. Staff were given work from the clinical trials core program which they could do remotely. This freed up a lot of space in the clinical trials core area where co-coordinators could spread out and stay safe.
"We even had physician teams from the cancer center move into the translational and clinical trials core area because there are big rooms in each space that can accommodate us," Milhem noted.
All this has kept their patients safe, he said. To date, the cancer center has recorded only about five cases of COVID-19; among hospital employees, about 100 have tested positive for the virus.
"If you ask me, 'Aren't patients afraid to come to the hospital because of COVID-19?', I would say that patients are more afraid of their cancer than the virus — so no, they are not afraid to come," Milhem said.
Milhem reports that he has served as a consultant or on the advisory board for Blueprints Medicine, Immunocore, Amgen, Trieza, Array Biopharma, BioNTech, and Novartis.
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Medscape Medical News © 2020
Cite this: How One Center Continues Cancer Clinical Trials Despite COVID-19 - Medscape - Jun 24, 2020.