Investigators point to a 'newfound flexibility' that may impact future clinical research
By the University at Buffalo
Almost all research at the University at Buffalo other than that focused on COVID-19 was paused on March 23. The move, a direct result of the growing pandemic, was made to reduce the risk of viral transmission. When UB administrators made that announcement, they noted it was a difficult but necessary decision made after a great deal of thought.
Now, more than three months later, a “research ramp-up” is underway.
“We are fortunate that UB’s research support infrastructure has been 100% operational through the research pause and subsequent staged ramp-up,” said Venu Govindaraju, Ph.D., UB’s vice president for research and economic development. “This enabled us to create and implement the research ramp-up plan in collaboration with our campus partners.
“UB researchers have been very responsive to the phased ramp-up plan and, through a cooperative process with the academic units, every investigator who needs to conduct essential research and time-sensitive research has the ability to return to their research facilities,” he said. “We encourage those who can function remotely to continue to do so. This limited return to facilities combined with ongoing remote operations allows us to resume time-sensitive research while focusing on the health and safety of our employees.”
“We’re very excited,” said Teresa Quattrin, M.D., senior associate dean for research integration in the Jacobs School of Medicine and Biomedical Sciences at UB and director of the Clinical and Translational Science Institute (CTSI) Special Populations core. She pointed, for example, to clinical trials in diabetes and endocrinology “that are very cutting-edge. We want to give the opportunity (to participate) to our patients in Western New York and beyond.”
For a clinical researcher like Quattrin, one element of the “return” means reopening clinical trials that were put on hold. In addition, some research that was handled remotely – or could not move forward at all – can now happen in person.
“It has been challenging,” she said. “Some of the visits that were scheduled for patients who were already enrolled in clinical trials had to be conducted remotely, the best we could.”
CTSI Director Timothy F. Murphy, M.D., SUNY Distinguished Professor in the Jacobs School and senior associate dean for clinical and translational research, has high praise for the researchers and staff members who have worked diligently to prepare for the return to clinical research.
“Our clinical researchers are anxious to get their studies restarted,” Murphy said. “Having said that, I am impressed with the careful and thoughtful planning that clinical research teams are doing to maximize the safety of participants and staff.”
Kimberly Brunton is co-associate director with Pamela Anderson of UB’s clinical research office, which provides expertise and support to investigators conducting human subject research.
“We are anxious to get all of our research ramped up to full potential,” Brunton said, together with hospital affiliates and partners’ reopening plans since UB’s studies often involve use of these services and facilities.
The agenda also includes studies related to COVID-19 and its devastating effects in Western New York and beyond.
“As we ramp up clinical research studies that were paused, we will also continue to bring new clinical trials of drugs and vaccines related to COVID-19 to Buffalo,” Murphy said. “We are investigating approaches to conducting these studies safely, including remote sites for enrollment and follow-up.”
Ensuring Safety for Patients, Staff & Researchers
At the Clinical Research Center, an outpatient research clinic located in UB’s Clinical and Translational Research Center, Brunton said all necessary precautions have taken place for the safety of the visiting participants as well as the safety of staff.
That includes screening for anyone coming into the unit. The center also established guidelines on personal protective equipment use, disinfecting and social distancing.
To ensure health and safety, UB has established defined protocols for all researchers, staff and patients.
In addition, strict protocols are in place regarding who is interacting with the patient. Considerations include the path the patient will travel to come to the center and identifying the most effective ways to limit contact between patient and staff.
“These are all steps that we’re putting in place in compliance with UB regulations and state regulations,” Quattrin said. “It’s essential to reopen, and to reopen safely and carefully, because this situation is here to stay. So, it would be a shame for people not to be able to take advantage of new potential advancements in a safe manner.”
Lessons For the Future
Clinical Research Office Director Sanjay Sethi, M.D., professor and chief, pulmonary, critical care and sleep medicine in the department of medicine in the Jacobs School, said COVID-19 has caused a re-think in terms of how individuals can and will participate in research studies.
“We have to think outside the box because of the pandemic,” Sethi said. “The traditional model has mostly been to bring the participant to the research site. We should now be figuring out how to take the research site to the participant.”
Sethi said the recent adoption of new technologies to connect at-home individuals and health care professionals may have an impact on the future of clinical research.
“The use of technology to conduct remote visits for clinical purposes could be adopted to conduct research visits,” he said. “There has been newfound flexibility because of the pandemic in many of the processes we had for establishing and conducting clinical research. It would be important to retain some of those enhancements and efficiencies once the dust settles down.”