Pediatric Clinical Research Amidst COVID-19
Ashley Dummer Jan 21, 2021
By: Reilly Wilson, administrative assistant, department of pediatrics
Most everyone’s daily routine came to an unnerving halt in March of 2020, as what was once an unknown illness discovered in China months before, rampantly spread across the world. This was no exception for clinical research in the Department of Pediatrics at Indiana University School of Medicine. The pandemic ceased most research studies conducted at Riley Hospital for Children for several months to ensure the safety of their staff and patients. Unless the study involved minimal interventions, no contact with the patients, investigational drugs that had already been administered, or a physical examination, research teams were told to discontinue their work for the time being. Once new procedures and safety guidelines were developed by the CDC, research was able to continue in late spring with minimal risk of spreading COVID-19.
When studies were able to resume, there was a different feel to the work and hospital environment. Many teams were downsized as staff members transitioned from working in the hospital to working from home where they would conduct virtual visits with patients. Several divisions agreed that this helped limit contact with patients to avoid spreading COVID-19 and served as a convenient, safe way to continue their work. Lisa Bendy, research manager for pediatric pulmonary, allergy, and sleep medicine said, “We have been very productive throughout the entire pandemic, even when working remote. Prior to the pandemic, we had a remote work policy in place for our group. This allowed some flexibility to people being able to complete work from home and still give 100% effort.” Bendy continued, “We worked to make remote [visits] and the virtual consent process as productive and effective as in person visits.”
Pediatric research team leaders reported that their staff were able to quickly adapt to working remotely and accommodating virtual appointments without many issues. However, these studies had to have amendments approved by sponsors, and added to their protocols, to allow for virtual visits or other types of home care. When asked how research practices may change after the COVID pandemic passes, Laura Carr, clinical research nurse coordinator for pediatric gastroenterology stated, “I think that research sponsors may allow for that [virtual visits] in their protocols and have realized how possible this really is to offer patients. Some sponsors have really investigated how home care can allow the protocol to meet its timelines and avoid conflicts with scheduling in person visits and some procedures.”
Most of the studies conducted by Pediatric divisions required physical examinations or administering investigational drugs during in-person visits. The pediatric oncology division was considered essential, even amid the spread of coronavirus, which led to patients continuing their treatment and new patients still being enrolled in clinical trials. Melissa Lee, director of clinical research operations with pediatric hematology and oncology, reported that there were 25 new trials opened during 2020 and there were nearly 70 patients enrolled in trials from March to June, when most other studies were at a standstill. The oncology research team utilized virtual appointments when appropriate, but also incorporated mailing out oral medications for the safety and convenience of the patients after the National Cancer Institute (NCI) approved these allowances.
Many individuals within Pediatrics believe that virtual visits will continue to be offered to some degree well after the decline of coronavirus. Parents of patients had obvious concerns about coming in for physical evaluations in fear of contracting the virus, but once the pandemic subsides, they believe that virtual visits will be a regular occurrence. Having virtual visits as an option is believed to help protocols meet timelines more regularly and has proved to help alleviate scheduling conflicts. Working from home also allowed employees to have more flexibility without seeming to affect efficiency or patient care. Pediatric pulmonology specifically implemented a Mental Health Wellness group created by James Chmiel, MD, and Deb Bagley. “It [mental health] is important in a time of separation to support each other,” Bendy shared, “Some days are better than other, but having our colleagues there to listen and share brings a little bit of normalcy to a very ‘tumultuous’ time.”
The Department of Pediatrics continues to weather the storm of this ongoing contagion, but the research itself has not changed much. Patients with COVID continue to receive treatment, while simultaneously being monitored to see if the virus has any adverse effects on them. The onset of coronavirus sparked some new research studies, one of which was developed by Chandy John, MD, and Alka Khaitan, MD, that looks at how the body’s immune system reacts over time to the virus. Lucy Miller, senior clinical research coordinator for the Department of Pediatrics and manager of the Children’s Clinical Research Center (CCRC), commented, “We completed enrollment last week and have enrolled 438 people (both adults and children). We’re asking participants to answer some questions about their health, exposure or lack thereof to COVID19, and to donate some blood so we can look at immunity markers.” It will take time to measure these results, as patients are tested four to six months after their initial bloodwork, another sample is collected after six months, and the final donation is collected 12 months later. “It’s a very interesting study that has been featured on WFYI and some of the local TV stations,” Miller added.
Although conducting clinical research went through a bit of a roller coaster last year, the Pediatric Clinical Research Divisions were able to quickly adapt and resume their work to help improve the lives of current and future patients. They found new ways to cope with adversity while still delivering high quality care to members of our community. Carr commented on how families have responded as well. “Parents of pediatric patients have been very flexible in continuing their participation in research by adjusting to these changes,” said Carr. Parents agree that research is an important mission for the hospital and are doing their best to follow changing protocols to accommodate these clinical trials.