“We’ve built a high-speed legal highway for researchers to use to share their data and samples.”Research organizations across Canada are encouraged to sign onto the new governing Data and Samples Sharing Agreement (gDSSA), a game-changing approach that will help get clinical studies started much faster for the benefit of patients.
Created by the Contracts Working Group of the Accelerating Clinical Trials (ACT) Consortium, this agreement has already been signed by more than 30 organizations from across Canada, and ACT hopes to reach over 250 signatories over the coming year.
“We heard loud and clear that it was taking too long to finalize contracts to move data and samples between Canadian research institutions. It was really slowing down research, but we are legally required to have these contracts,” said Jennifer Cox, Co-Chair of the ACT Contracts Working Group and Legal Counsel & Manager, Research Contracts at The Ottawa Hospital’s research institute. “So, our solution was to create this pan-Canadian master agreement where most of the legal work has already been done. Researchers just need to plug their study details into a two-page checklist which can be quickly reviewed by their institution’s contracts or legal office. It’s like building high-speed legal highways for researchers to use to share their data and samples.”
The Ottawa Hospital’s research contracts team handles around 800 data and transfer agreements every year. After signing onto the gDSSA, they found the time needed to finalize these agreements fell dramatically to just 10 days.
“There is no downside to institutions signing onto this agreement,” says Breanne Stewart, Co-Chair of the ACT Contracts Working Group and Network Director, RareKids-CAN, affiliated with the Maternal Infant Child and Youth Research Network (MICYRN). “It will not override institutions’ existing contracts processes and it’s optional to use for any given project. However, it does give their researchers the chance to speed up their data and sample transfer contracts with other institutions that are part of the agreement. The more institutions that sign on, the better it will be for Canadian research and patients.”
Addressing the challenge of slow study starts
Starting a clinical trial can take a long time, especially for multi-site trials that must accommodate different procedures at each site. Because of this, some clinical trial sponsors decide not to have sites in Canada and patients miss out on accessing new therapies. This is exactly the type of barrier that the ACT Consortium is aiming to tackle. Streamlining our processes across the country will make Canada more attractive to clinical trial sponsors.
The ACT Consortium, co-led by Population Health Research Institute (PHRI) of McMaster University and Hamilton Health Sciences, The Ottawa Hospital, and nine other institutions across Canada aims to transform Canada’s clinical trials landscape by removing barriers, streamlining approvals, enhancing support and facilitating the engagement and participation of patients and other stakeholders.
“This gDSSA will not only speed up contracts, but it helps protect institutions from staffing turn-over and high workloads. It gives institutions the capacity to actually focus on the issues that matter,” said Dr. Dean Fergusson, senior scientist at The Ottawa Hospital and professor at the University of Ottawa and one of the key architects behind the ACT Consortium.
The gDSSA also makes clinical research participation more accessible to smaller research entities that do not have lawyers on staff to review contracts, as they can trust the agreements are legally compliant.
“Fundamental to multi-site trials and research is being able to share and transfer patient data and samples between organizations,” said Dr. PJ Devereaux, ACT Operations Committee Co-Chair and senior scientist at the Population Health Research Institute (PHRI) of McMaster University and Hamilton Health Sciences. “With this new legal tool, we are revolutionizing how clinical research contracts work in Canada. As more and more research organizations sign on, we hope this efficient new way of working will ‘go viral’ and spread across the country.”
The gDSSA is only the first of a series of "legal highways" that the ACT Contracts Working Group is developing. The working group includes over 70 people from over 30 institutions.
If a Canadian research entity wants to become a signatory on the gDSSA, they should contact contracts@ohri.ca.
Funding: The Accelerating Clinical Trials Consortium is generously supported through multi-year funding from the Canadian Institutes of Health Research’s Clinical Trials Fund, as part of Canada’s Biomanufacturing and Life Sciences Strategy to ensure that Canadians are well served by a national clinical trials network.
The Ottawa Hospital is a leading academic health, research and learning hospital proudly affiliated with the University of Ottawa and supported by The Ottawa Hospital Foundation
