Clinical Trials Office juggles research work, life amid a pandemic
Michael Schug Oct 02, 2020
For all of us now, we mark our lives—both personal and professional—as life before the pandemic and life after the pandemic began.
Before the World Health Organization declared the spreading coronavirus outbreak a pandemic on March 11, the staff of the IU Simon Comprehensive Cancer Center’s Clinical Trials Office (CTO) was going about their important work.
While their work has changed since then, cancer clinical trials never stopped. In fact, in the face of uncertainty, the staff has increased patient accrual over last year and streamlined some administrative tasks.
The 100-plus staff members include data coordinators, clinical research specialists, research nurses, and others.
“Everyone plays an important role in supporting the principal investigators who conduct oncology clinical trials,” according to Mario Contreraz, M.B.A., M.S.N., R.N., director of operations of the CTO. “We have dedicated staff who are the backbone of our research efforts.”
It’s no small task considering that the PIs lead hundreds of trials. In addition to evaluating potential new prevention, diagnostic, or therapeutic approaches, these trials are often the last line of defense for patients when standard therapies have failed. The majority of these trials are only available at academic health centers and their affiliated cancer centers due to the rigorous demands of managing clinical trials and the complexity of patients’ health.
Accrual to both therapeutic and non-therapeutic trials remained strong in the beginning of 2020. But the new year, as everyone knows, brought with it a new virus that first hit the United States on the West Coast in January. The impact of the coronavirus, renamed COVID-19 in mid-February, reached the Midwest in early March. Indiana reported its first case on March 6.
On March 10, Contreraz held an emergency meeting with the CTO’s managers to identify essential staff who would be needed on campus. Around this time, the office was managing close to 300 trials.
The next day, IU suspended all in-person meetings, implemented visitor restrictions, and told employees who were able to work from home to do so.
“There was no playbook to manage a pandemic and work. Nobody knew what to expect,” Contreraz said. “For days, things changed hour by hour, day to day and week to week. The CTO staff did a tremendous job of overcoming a number of obstacles.”
With most of the CTO staff now working from home and adjusting to their new work routines in early March—as well as juggling personal lives amid a pandemic—the trials continued. However, not everyone could work from home. Many of the therapeutic trials meant that research nurses needed to meet with patients.
Contreraz praised those research nurses: “My hat goes off first to the research nurses who continued to provide the same level of quality patient care to our patients despite the pandemic.”
On March 24, non-therapeutic trials were suspended unless they could be conducted virtually or remotely. That allowed the CTO staff to shift their attention to the therapeutic trials.
By the end of March, the CTO’s hard work—work being done in the very early weeks of the pandemic—led to 31 patients accruing to a clinical trial. Accrual hit a low in May, but rebounded in June and has continued its upward trajectory. By late August, the CTO managed to accrue a total of 204 patients, which is a 10-percent increase from the previous year.
That’s impressive, considering new patient accrual decreased 30 percent in May. CTO leadership pointed to other cancer centers, which experienced accrual decreases up to 70 percent.
“I think part of our success was really quick action by the CTO leadership in realizing that we would need to have staff working from home and we would need to adjust and develop new procedures to be able to do that,” Kathy Miller, M.D., the cancer center’s associate director of clinical research, said. “I think the key was prioritizing the work.”
Contreraz added: “We ensured that the staff had the tools—computer, laptops, and VPN access—to be successful at home.”
Dr. Miller summed all of the uncertainty and the new world order perfectly in an e-mail that was sent to the CTO staff: “A huge thanks for the perseverance. Many are not ‘working from home.’ They are ‘home managing a crisis while trying to work.’ The difference might seem subtle, but it is very real.”
During a recent interview, she elaborated on the staff’s efforts. “The staff have a lot of other roles in their families and in their communities, so they are doing the same juggling act that we all are,” she said. “They have an incredible commitment to our patients and to the work the center does on behalf of our patients. And we have definitely seen that incredible commitment as they have continued to work with us. They've been incredibly flexible in how we get the work done. They've been incredibly creative in finding new ways for us to do things, some of which we've discovered work way better than the way we were doing before the pandemic.”
Tim Lautenschlaeger, M.D., medical director of the CTO, added: “The entire CTO staff has done an incredible job adapting to all the changes. Looking back, it is impressive how well the office continued to function, supporting our PIs and serving our patients. I am very proud to work with such dedicated individuals.”
“In oncology, clinical research is not just a standard of care, it is the standard of care. Until every patient diagnosed with cancer is cured, this sentiment will remain. Clinical research does not happen in a vacuum, it takes a team. In these uncharted times, I join with all of our members in expressing our deepest gratitude to the staff and leadership of our CTO,” Patrick Loehrer, M.D., cancer center director, said.
Much like elsewhere, the CTO has discovered ways to be more efficient because of the pandemic. They started electronic signatures for patient consent forms and e-signatures for regulatory documents. The pandemic also has led to remote monitoring of clinical trial results. Prior to the pandemic, monitors needed to be on-site to review study data. That’s not always the case now since the data can be reviewed remotely.
Some of the new changes are here to stay.
“Some of the changes are things we've wanted to do for some time, but there were security concerns and regulatory concerns,” Dr. Miller said. “The Institutional Review Board and IU Health have allowed us to do some things that are much more efficient for us. Some of those will continue.”
“We proved we can successfully work remotely to support clinical trials at the cancer center and will continue to do so,” Contreraz added.
Michael Schug, an award-winning communicator, is the communications manager at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center. In this role, he promotes the impactful research generated by the center’s nearly 250 scientists and physician-scientists to both external and internal audiences.