> Advancing clinical research in the age of COVID-19
Advancing clinical research in the age of COVID-19
In clinical trials, both patients and faculty have to carefully balance potential benefits against potential risks in deciding who should be in a clinical trial—and this year the Byers Eye Institute at Stanford faced a new risk in that calculation. The first case of novel coronavirus (COVID-19) in the Bay Area was diagnosed near the end of January 2020. Case numbers continued to grow locally and on March 16, six Bay Area counties announced a shelter-in-place order. Since then, COVID-19 has changed lives for people worldwide. Students adapted to online education, celebrations switched to a virtual format, and masks and distancing became the new way of life.
Teams at Stanford also made necessary changes as faculty and clinical leadership prioritized the safety of patients, employees, and the community. University and health system leaders worked closely with government and public health agencies and continue to follow guidelines from the U.S. Department of State, the Centers for Disease Control and Prevention, the World Health Organization, and state and local authorities.
“We have to protect our patients today, but also continue our mission to lead a path to the future. Clinical trials are critical to getting there, and I’m grateful to have a skilled and committed team at the Byers Eye Institute.
Some of the important safety changes that took place because of COVID-19 included identifying essential clinical research, training staff and patients to new protocols, and changing to remote work when possible—but for those involved in clinical trials, not all work could be done remotely.
While closely monitoring the outbreak, the department sought ways to continue clinical trials during the pandemic with minimal extra risk to health—balancing the risk of virus transmission against the risk of delaying potentially vision-saving therapies. With everyone’s safety as the top priority, the department clinical trials team leapt into action.
Delivering therapies and prioritizing safety
“At the beginning of the shelter-in-place order, we had to react quickly. We only kept studies open where human subjects were already enrolled and whose ongoing treatment was considered essential for the subject’s vision and safety,” Mariana Nuñez, Clinical Research Manager, said. “We had to temporarily pause some clinical trials, and for those that continued, we temporarily didn’t enroll new subjects.”
Nuñez helps lead a team of over a dozen clinical research coordinators (CRCs) and clinical research fellows who are part of the Mary M. and Sash A. Spencer Center for Vision Research at the Byers Eye Institute. When Nuñez first joined the department nearly five years ago, there were about eight open trials, but now faculty clinician-investigators are running over 40.
“The growth in clinical trials reflects our department’s focus on translational research,” Heather Moss, MD, PhD, associate professor of ophthalmology and director of clinical research, said. “The only way to move advances in the laboratories into advances in patient care is through clinical trials.”
Nuñez and the other CRCs act as a liaison between all parties involved in a clinical trial, and are responsible for the day-to-day work of running clinical trials, including enrolling and guiding subjects in the studies and helping them understand and navigate being a study participant, managing data, and ensuring compliance with the IRB and the U.S. Food and Drug Administration.
In April, strict guidelines were set in place for clinical trials. Subject testing and in-person visits were reduced, many visits were switched to video, and for some studies, medications had to be shipped directly to the patient’s home.
By May and early June, there was better understanding of how to reopen for in-person clinical trials in a safe manner. Personal protective equipment, universal masking, and physical distancing protocols were established. All research staff were tested negative for COVID-19 before coming back to work in person. A detailed calendar was used to stagger who was in the building. General hygiene was continued by washing hands, wearing gloves, and sanitizing work spaces. Subjects who came in for trials were screened prior to their visit for symptoms, fever, illness, or recent travel—just as all staff did a similar daily screening and attestation.
“We took a lot of extra steps to make sure study subjects and ourselves were kept safe,” Nuñez said. “There is a general fear that anyone could get infected, so anything we can do to reassure patients is helpful.”
An investigator’s perspective
The faculty clinician-investigators have been integral to assessing potential risk and benefit to patients and adapting trial design and data collection and analysis procedures. Theodore Leng, MD, MS, associate professor of ophthalmology and director of clinical and translational research, researches novel treatments for macular diseases and machine learning applications for tele-ophthalmology. Although he had to temporarily pause patient visits during the initial stages of the pandemic, he quickly adapted to avoid negative impact on research progress.
“We had to make changes, such as create new procedures to keep research subjects and research staff socially distanced, establish new health screening/hygiene protocols and introduce appropriate PPE to the workflow, but we were still able to continue providing therapies to these patients.” Leng said.
Diana Do, MD, professor of ophthalmology and vice chair for clinical affairs, is a national leader in retinal therapy-related research studies. Do worked collaboratively with industry sponsors of clinical trials to ensure that in-person patient visits were minimized to only the absolutely necessary study procedures.
“Clinical research is a very critical component of care of patients with vision threatening eye diseases, and access to the latest therapies and diagnostics is why patients come to Stanford,” Do said. “Our team has been dedicated to create a safe environment for our study subjects to ensure that they receive these study therapies that can save patients’ vision.”
Through a team effort, they hope to continue growing the number of ongoing trials in the future while still prioritizing patient safety and care.
“We have to protect our patients today, but also continue our mission to lead a path to the future,” Moss said. “Clinical trials are critical to getting there, and I’m grateful to have a skilled and committed team at Byers.”
By KATHRYN SILL
Kathryn Sill is a web and communications specialist for the Byers Eye Institute in the Department of Ophthalmology, at Stanford University School of Medicine. Email her at email@example.com.