COVID-19: Ontario’s clinical trials community rising to the challenge
This story was originally published in Life Sciences Ontario’s (LSO) 2020 Success Stories.
With a highly efficient clinical trials system already in place and world-class institutions and sponsors working collaboratively, Ontario has been able to move COVID-19 research forward quickly. There are more than 75 COVID-19 clinical trials and observational studies underway across 240 trial sites in Ontario, according to data collected from CTO Stream, the province’s research ethics approval platform powered by Clinical Trials Ontario (CTO). These studies have been and continue to be central to Ontario’s response to this global pandemic. They are showing the efficacy and safety of interventions and are guiding our understanding of the disease.
CTO is enabling these trials to get up and running quickly by providing single ethics review for multi-centre studies, and Ontario’s clinical research community is ensuring that trials are conducted safely in our new reality. A high level of collaboration among researchers, trial sites and study sponsors has allowed for innovation in clinical research conduct that will lead to an even stronger clinical research environment in Ontario.
COVID-19 studies occurring across Ontario
Ontario is known as a leader in conducting innovative clinical trials, and the research community’s response to this pandemic has proven our strength in this area. Studies being conducted in Ontario are assessing a wide range of medications, mobile monitoring programs, smell and taste, and more. These studies are offering today’s patients access to potentially beneficial treatments while allowing doctors and researchers the opportunity to increase their knowledge of COVID-19. The studies highlighted below are just a glimpse into the important COVID-19 research occurring in Ontario:
- The REMAP-CAP trial, led by Dr. John Marshall of St. Michaels Hospital, is using a novel trial design known as a platform trial to analyze multiple interventions simultaneously. Dr. Marshall and the global critical care research community began working on this research platform in 2011 in order to expedite research in the face of future pandemic need. In the current COVID-19 pandemic, the goal is to generate evidence that will reduce morbidity in severely ill patients with COVID-19.
- The Palm Berry Extract in COVID-19 Patients trial, led by Ontario researchers Dr. Michael Farkouh and Dr. Ana Andreazza of the University of Toronto, is testing whether an early intervention of acai palm berry extract can improve the recovery of patients with COVID-19 and help to prevent complications caused by inflammation.
- An observational study led by the Royal Institute of Mental Health Research is examining the psychological, social and financial impacts of the COVID-19 pandemic at various stages of the outbreak. This study, titled “How are you coping”, is using an online survey distributed by multiple hospitals including the Ottawa Hospital, the Children’s Hospital of Eastern Ontario, Sunnybrook Hospital, Southlake Regional Health Centre, and the Centre for Addiction and Mental Health.
To learn more about the multi-site COVID-19 studies occurring across Ontario, visit CTO’s COVID-19 Resources and Updates page.
Enabling COVID-19 trials to start quickly
Enabling timely and effective clinical trials is vital to discover effective treatments for COVID-19 patients. This does not mean shortcutting safe research, but rather streamlining research processes to get effective treatments and vaccines to people faster. CTO, Ontario’s designated clinical trials organization, plays a critical role in improving our health research ecosystem by enabling a single ethics review for multi-centre studies through its CTO Stream platform.
Research ethics reviews of new COVID-19 studies in CTO Stream are being completed in 16 days on average, and sites are approved to join these studies in six days (avg). “Efficiency and speed are of critical importance in the race for solutions against COVID-19. CTO Stream was built for this moment. It is thanks to the efforts and support of Ontario’s clinical trials community, and especially our Research Ethics Boards, that the CTO Stream program is available as a tool during this challenging time,” said Susan Marlin, President and CEO of Clinical Trials Ontario.
CTO’s mission is to strengthen the clinical trials environment by streamlining processes to help make high-quality clinical trials more timely, efficient and cost-effective. In the context of the COVID-19 pandemic, the urgency of this mission is amplified. CTO is proud to support the research community and advance COVID-19 research as quickly as possible.
Ensuring safe, socially distanced conduct of trials during COVID-19
While CTO has been working to get multi-site COVID-19 trials off the ground quickly, clinical trial sites, sponsors, CROs and Private Research Networks across the province have been tasked with the challenge of conducting clinical trials in a responsible way during the COVID-19 pandemic. Since the onset of the pandemic, hospitals such as the University Health Network and Lawson Health Research Institute have taken on this challenge with great success. These hospitals are only a couple examples of the many sites across Ontario working on solutions to allow for safe, effective and socially distanced clinical research in our new reality.
One of the main challenges these hospitals have tackled is the establishment of remote monitoring access for study sponsors. In order to conduct clinical trials, study sponsors must be able to perform monitoring of the trials. To limit the number of non-essential visitors within hospitals, this monitoring must now be done remotely. Prior to the COVID-19 pandemic, UHN and Lawson did not have systems for remote monitoring in place. However, through collaboration with study sponsors, they were quick to adapt. CTO spoke with representatives from both UHN and Lawson about their innovative remote monitoring solutions. Both hospitals have established remote monitoring through screen sharing, and both are establishing direct, secure, remote access to electronic medical records.
The future of clinical research in Ontario
Despite the challenges brought on by the pandemic, we have seen encouraging signs from the clinical research community in Ontario as they leverage technology to conduct trials safely and efficiently. CTO is taking on a lead role in helping to steer our community through this challenging time by facilitating cross-stakeholder working groups to establish best practices and harmonized solutions for Ontario’s clinical trials community.
The COVID-19 pandemic has provided the opportunity to establish a ‘new normal’ for clinical trials conduct in Ontario. The community is looking ahead to a more virtual future through new approaches to research, including the use of remote monitoring, electronic site files, electronic consent and electronic signatures. The high level of collaboration within Ontario’s clinical research community is making these changes possible, and Ontario’s clinical trials environment is well positioned to come out of COVID-19 even strong than ever.