Clinical trials in cancer at Iowa barely lose a step

Last week, the American Society of Clinical Oncology (ASCO) released a special report titled “A Guide to Cancer Care Delivery During the COVID-19 Pandemic.” It details an approach for oncologists and other care providers to ensure their own safety and that of those they treat, given the higher likelihood of a patient’s immuno-compromised status. 

For providers at University of Iowa Health Care in the Holden Comprehensive Cancer Center (HCCC), these guidelines were welcome but they did more to confirm what has already been settled routine for a couple months. Strict care precautions within the HCCC and throughout the rest of UI Health Care allowed a significant portion of care for people with cancer to continue. When most clinical trials around the country had to halt because of worries over the availability of protective equipment and other safety concerns, more than 95 percent of all therapeutic clinical trials within the HCCC were able to continue.

Oncology Section Chief Mohammed Milhem, MBBS, is associate director for clinical research in the HCCC and a principal investigator on more than twenty open clinical trials. He marveled at the difference between what Iowa achieved versus what other institutions were forced into. “Some places just closed everything. We did the opposite.” Iowa had a plan and support for keeping as many of the trials going as possible. Discussions between HCCC leadership and J. Martin Scholtz, PhD, UI Vice President for Research, were productive. “[Scholtz] told us, ‘If you can say it’s life-saving therapy, you can keep the trial open.’” And for almost everyone whose cancer brings them to Iowa City for care, Milhem explained, participation in trials really is essential. “I felt we could keep going, and we did it. Very nicely.”

But just putting a stamp on a trial that read “essential” was not enough. Calling the initial work in that period of transition “labor intensive,” Milhem acknowledges and is grateful for the work of many to ensure compliance, that every contingency had been addressed. “Coordinators, PIs, the pharmaceutical companies sponsoring some of these trials, everyone had their own regulations, the FDA. But everyone was consulted.” With so many stakeholders, he says, a comprehensive plan was established and agreed upon in an unusually short period.

Milhem also allows that a lot of variables broke in Iowa’s favor to make continuing trials safe. A relatively slow rise in COVID-19 cases in the region gave providers time to prepare. In addition, the main campus of University of Iowa Hospitals & Clinics design is spread out, and a carefully monitored entrance near the cancer center reduced patients’ time and exposure on site. The patients themselves were unconcerned about the risk; few hesitated making the trip onto campus. “They have a bigger fear,” Milhem said. “They tell me, ‘I’m already fighting for my life.’”

One challenge that providers did have to overcome was the hospital’s restriction on visitors, imposed mid-April. But hospital administration was willing to make exceptions for many patients coming to the HCCC. With cancer, especially a new diagnosis or a change in treatment strategy, Milhem said, “You need to have someone present. More ears in the room.” If that additional set of ears could not be there in person, patients often opened up a video call on their phone or tablet to bring support into the room.

Similarly, telemedicine was another tool in the HCCC’s ability to maintain continuity in their trials. After initial “intense” visits at the beginning of an investigational drug, which often requires blood tests and close monitoring for hours after administration, many trial participants do not need to keep returning to campus. Instead, regular check-ins over phone and video help trial participants stay out of any public spaces at all. And, Milhem points out, many travel to Iowa City from far away just to participate in these trials. Preventing their need to travel and helping them remain with their families is good under any circumstances, but especially in a pandemic.

As people return to their primary care providers and new diagnoses begin to increase again, Milhem sees a similar increase in the number of new trials making their way to HCCC. “We have been opening trials at our regular pace,” but he finds an environment now more conducive to resolving typical bottlenecks. This discovery, that hard things do not always have to be hard, combined with the imminent return of biospecimen, observational, and translational research may leave cancer research at Iowa even stronger than before.