Clinical trial sites and sponsors across the province have been tasked with the challenge of conducting clinical trials in a responsible way during the COVID-19 pandemic. One of the main challenges has been establishing remote monitoring access for study sponsors. Since the onset of the pandemic, Lawson Health Research Institute (the research institute of London Health Sciences Centre and St. Joseph’s Health Care London) has been working on developing innovative solutions for remote monitoring to allow for safe and effective research in our new reality.
Clinical Trials Ontario spoke with a couple of the key individuals at Lawson Health Research Institute responsible for developing remote monitoring solutions, including Cheryl Litchfield, Manager, Research Administration, and Janet Knechtel, Senior Quality Assurance and Education Officer.
Current preferred option for remote monitoring
“Our current guidance identifies source data verification through the hospital’s approved video conferencing platform as the preferred option for remote monitoring,” said Cheryl Litchfield. With this method, an authorized member of the research team and a sponsor monitor must both be in a private location. They can then conduct the monitoring through an approved video conferencing platform with screen sharing or webcams. The use of recordings and screenshots is not allowed throughout these monitoring sessions. This method for monitoring requires a new way of preparing for a monitoring visit, and there is additional upfront work for the research team. However, Lawson feels it is the best option at the moment for both research teams and monitors. “This is the safest option when it comes to protecting personal health information for monitoring,” said Janet Knechtel.
Working with sponsors to create innovative solutions
Lawson has been working closely with sponsors to ensure that their remote monitoring needs are being met. “Monitoring is the responsibility of the sponsor under the regulations, so early on in the COVID-19 pandemic, we reached out to the sponsors and CROs that we work with on a regular basis to find out what their expectations were for monitoring alternatives,” said Knechtel. During this outreach, one of the sponsors suggested the possibility of Lawson providing in-house monitoring on behalf of the sponsors. This innovative approach intrigued the team at Lawson, and they began exploring the possibility. Lawson is looking into providing a local team, independent from the research team, that could verify source data on behalf of sponsors. “We have identified a team internally that has the right expertise to offer this service, and we are in the initial stages of exploring the logistics of this option,” said Litchfield.
Sponsors have also expressed interest in remote Electronic Medical Record (EMR) access. “We are currently exploring this possibility with our Health Information Management and IT teams,” said Litchfield. This solution, however, could come with its own challenges. “Most of our source documents are still heavily paper based, so one of the challenges we are working on now is getting those documents into an accessible form electronically for monitors,” said Knechtel.
The future of clinical research at Lawson Health Research Institute
Both Litchfield and Knechtel believe this is going to lead to a new way of working across the board. “Clinical research needs to move towards an electronic world, and the COVID-19 pandemic has given us a push to get there” said Knechtel. “Remote monitoring is opening the door to look into the possibilities of using e-source data, e-consent and e-signatures within clinical research.”
Litchfield and Knechtel have also been impressed with the level of collaboration within the clinical research community that has resulted from this pandemic. “I’ve been really impressed with the cooperation and sharing of information among the institutions,” said Litchfield. “It’s been exciting to be part of discussions across Ontario and Canada to see how we can work together to come up with solutions in order to conduct good quality research,” said Knechtel.
Learn more: Ontario’s Working Group for Clinical Trial Restart
While Lawson Health Research Institute is one example of successful collaboration and innovation in remote monitoring, hospitals and sponsors across the province are also working on solutions. To learn more about remote monitoring solutions across the province, watch the recording of the webinar “Ontario Clinical Trial Restart: Sharing Solutions on Remote Monitoring”, led by Clinical Trials Ontario with participation from the University Health Network, Lawson Health Research Institute, Sunnybrook Health Sciences Centre, and Southlake Regional Hospital.