Ontario has a lot to offer when it comes to conducting clinical trials. Industry looks to Ontario because of our world-class key opinion leaders, our expertise in a number of important research areas, our high-quality data and our diverse patient population. But these advantages only come into play once a trial is up and running. The typical trial can take more than five months to get started, which drains time, resources and energy for research institutions and industry sponsors.
QuickSTART, a program developed by Clinical Trials Ontario (CTO), is significantly speeding up this process. Launched as a pilot in early 2019, QuickSTART enables clinical trials sites and industry sponsors to set targets and establish standardized processes to improve efficiency and achieve activation within just 90 days.
The 90-day start-up target caught the attention of Novartis, one of the first industry sponsors to participate in the QuickSTART pilot. Novartis used QuickSTART’s innovative digital platform to expedite the start-up for two new clinical trials, in partnership with trial sites, University Health Network and St. Joseph’s Health Care London. The trial groups have now successfully completed the QuickSTART process, kicking off their trials faster than ever before.
“Novartis is pleased to have taken part in the first QuickSTART pilot as we continuously strive to improve efficiencies in clinical trial conduct so that more patients can have the opportunities to take part in our trials,” said Monique Lacroix, Country Head, Global Development Operations/Trial Monitoring. “The improved start-up timelines exceeded our expectations and we look forward to repeating the experience.”
“Going through this exercise showed us that a 90-day start-up goal is in fact achievable when all parties are actively engaged and work together toward a common goal,” said Dr. Bradly G. Wouters, Executive Vice President, Science and Research at the University Health Network. “We look forward to expanding the QuickSTART program across UHN.”
“Lawson Health Research Institute was delighted to be selected as a QuickSTART pilot site. With a dedicated research team and enhanced communication amongst stakeholders, we met the QuickSTART timeline of 90 days to initiation,” says Cheryl Litchfield, Manager, Research Administration at Lawson. “We use the Canadian model Clinical Trial Agreement and industry-sponsor master agreements which were key enablers. It was great to see what was possible with focused effort.”
Collaboration is key to expediting the start-up process
In addition to facilitating faster trial start up times, the QuickSTART platform presents other unique advantages.
“One of the most valuable things about participating in the QuickSTART process was the platform itself,” says Olivera Sutakovic, Clinical Research Manager at Department of Ophthalmology at University Health Network’s Toronto Western Hospital. “Being able to easily log in and see where the documents were in the process and who was responsible for next steps gave us the support to move forward faster, both internally and with our industry partners.”
Participants of the pilot noted that collaboration and shared responsibility were central enablers to the QuickSTART’s streamlined process.
“We are always looking for ways to make research more efficient to provide patients with better care,” says Julie Duncan, Lawson Research Coordinator for Dr. John Gonder’s team at St. Joseph’s Health Care London’s Ivey Eye Institute. “The QuickSTART system allows for greater organization of start-up activities, along with a means to assign and track progress. The combined efforts of all parties showed that collaborative teamwork can help to expedite the start-up process. We look forward to using QuickSTART again in the future!”
Key outcomes of the QuickSTART pilot:
- Shared interface enables authentic partnership between industry and institutions and helps to break down silos within institutions
- Dynamic and flexible platform does not disrupt internal procedures, but enables a more streamlined approach to setting milestones and meeting timelines
- Setting transparent targets, responsibilities and mutual agreement at the outset gives participants license and support to move the process forward
Start your next trial in just 90 days
QuickSTART enables pharmaceutical, medical device and medical technology companies to get their trials off the ground more quickly. The QuickSTART pilot is looking for more industry participation and input to help shape the program and ensure it is meeting the needs of sponsors. Ontario trial sites can work with Clinical Trials Ontario to become QuickSTART ready and eligible to participate in studies through this platform.
Institutions and industry interested in establishing a streamlined start-up process to achieve a 90-day target can contact the QuickSTART team.
Add rescue sites to your trial in less than two weeks
Part of Clinical Trials Ontario’s mission is to make clinical trials more effective and efficient, reinforcing Ontario’s role as a leading jurisdiction for conducting high-quality clinical trials. In addition to QuickSTART, our CTO Stream program is driving efficiency by enabling a single ethics review process for multi-site clinical trials in Ontario. With CTO Stream, industry sponsors have their hand on the steering wheel and are able to add rescue sites to multi-site studies in less than two weeks. Together, CTO Stream and QuickSTART help industry and institutions collaborate effectively and bring new treatments to patients and families more quickly.