The efforts of local experts moved clinical research into high gear to respond to an urgent need.
The race to find treatment approaches to improve patient outcomes and end the COVID-19 pandemic has involved the coordination of research teams and patients across British Columbia. At the helm of this undertaking is the COVID-19 Clinical Research Coordination Initiative (CRCI), of which Vancouver Coastal Health Research Institute (VCHRI) scientist Dr. Theodore Steiner is a member.
“The CRCI facilitates clinical research between all six health authorities in the province,” says Steiner.
“The way we did things previously was not as nimble, which is why we needed to harmonize processes to match the urgency of the present situation.”
The CRCI consists of several health research-based working groups, including psychosocial, biomedical and data coordination working groups. Steiner co-leads the clinical research arm, which is primarily concerned with studies that rely on patient recruitment.
Group members are physicians, health authority representatives, scientists, Clinical Trials BC representatives and patient partners who have experience representing the interests of patients and research participants.
As an oversight body for COVID-19-related clinical research studies, the CRCI helps avoid the duplication of efforts and overtaxation of a single health authority and particular group of patient participants.
“For example, a pharmaceutical company may require that scientists lead a study. If they put out a call to several investigators at a hospital, many may volunteer to take on the project when there should only be one lead investigator per medical site,” explains Steiner.
This resource was a welcome helping hand for VCHRI researcher Dr. Sara Belga, who connected with the CRCI about the mild CONTAIN COVID-19 study that she is working on as the Vancouver-based principal investigator.
“The process was very efficient and easy,” recalls Belga. “After I submitted my proposal in June 2020, the CRCI responded with an email stating that the committee supports my research and finds it important and valid. They also directed me to the REACH BC platform for study participant recruitment, as well as other resources.”
“It was good to have their stamp of approval to make sure that I was not going to pursue a study that may not be as relevant or may duplicate the efforts of other researchers.”
Laying the groundwork for changes that could last into the future
By acting as a clearinghouse for studies—as well as an information hub for any concerns investigators may have about study operations—the CRCI also helps manage and streamline the great deal of paperwork that can slow operations.
“There is a huge amount of work that goes into contracts and confidentiality agreements that can be overwhelming for health authorities,” recalls Steiner of the pre-CRCI days.
Every clinical trial has a sponsor who designs and oversees the study and its data interpretation, notes Steiner. The sponsor recruits investigators who carry out the work. Their respective roles and responsibilities, along with costs associated with the study and other aspects of the research undertaking, are described in a contract.
By parsing through studies in advance and avoiding competition between researchers for resources, the CRCI has been able to speed up the launch of vital COVID-19 research.
“Working with experts around the province, we are seeking a way forward to facilitate research while observing the legislation and guidelines around patient confidentiality and privacy.”
“In this way, we aim to move the research coordination processes established through the CRCI into areas outside of COVID-19 to put into place lasting changes.”
Researchers can learn more and submit a proposal via the CRCI website.