Streamlined System provides nimble, efficient ethics review of multi-centre clinical trials, while maintaining highest ethical standards
June 16, 2015 – Clinical Trials Ontario’s (CTO) ‘streamlined’ approach for the ethical review and oversight of multi-centre clinical trials was launched internationally today at the 2015 BIO International Convention in Philadelphia, PA with the announcement that the first industry clinical trial sponsor, GlaxoSmithKline (GSK), has successfully used the Streamlined System to receive ethics approval.
The CTO Streamlined Research Ethics Review System allows any single ‘CTO Qualified’ research ethics review board in Ontario, Canada’s most populous province, to provide ethical review and oversight on behalf of multiple research sites involved in a clinical trial.
GSK’s global multi-centre clinical trial has received province-wide ethics approval of the study protocol in Ontario in just two months from the time of submission.
With the ethics approval now in place, the study is ready to add on sites in Ontario that will take days to approve instead of months, which can be the case in jurisdictions where studies may need to undergo an ethics review at each site.
“The CTO Streamlined System provides a timely, efficient and effective approach for reviewing multi-centre clinical research in Ontario. It will improve the speed and reduce the costs of doing multi-centre trials, while maintaining the highest ethical standards,” CTO President and CEO Susan Marlin said today at the launch of the new system.
Dr. Ghislain Boudreau, Vice President, Public Affairs, Pfizer Canada added his voice of support and partnership at today’s international launch. He said: “Today is an important day for clinical trials in Ontario. The CTO Streamlined System is going to enrich the clinical trials environment in Ontario and open the door to more clinical trial activity in this province. We would like to express our support for the new system among the many advantages that Ontario offers as a location to conduct clinical trials.”
A stakeholder-led organization established with support from the Government of Ontario in 2012, CTO has been working with the clinical trials community over the past two years to design and build the CTO Streamlined System.
The Honourable Reza Moridi, Ontario’s Minister of Research and Innovation, said: “There are so many reasons to locate clinical trials in Ontario: world-class researchers and clinicians, established networks, high-quality research infrastructure – to name just a few. And now, Ontario will become an even more attractive place to conduct this important research. Clinical trials advance medical knowledge, enhance the health of Ontarians and are an important part of our innovation economy, attracting direct investments and creating jobs.”
The CTO Streamlined System can be used for both industry-sponsored and investigator-initiated multi-centre clinical trials and health research.
All research ethics review boards participating in the system are ‘CTO Qualified’ through the CTO REB Qualification Program. This program provides an external review of their governance, membership, operations and review procedures to ensure that a certain standard is met to deliver on high quality ethics reviews.
Although the system was finalized only a few months ago, 9 research ethics boards in Ontario have become CTO Qualified and 23 research sites have signed on to participate in the CTO Streamlined System. Facilitating the process is a web-based platform called CTO Stream.
“The new streamlined approach is expected to provide significant benefits to everyone involved in clinical trials by harmonizing processes and reducing the time and administrative burden involved in initiating research across multiple sites in Ontario. This is a tremendous opportunity to enhance the environment for conducting multi-centre clinical trials in Ontario,” said Marlin.
“Ontario has the capacity to take on more clinical research. CTO’s streamlined approach can help Ontario capitalize on its clinical research strengths and attract more global clinical trials.”
About Clinical Trials Ontario
Clinical Trials Ontario (CTO) is an independent not-for-profit organization established with support from the Government of Ontario. CTO’s mandate is to provide a streamlined approach to conducting multi-centre clinical trials in Ontario. The vision of CTO is to make Ontario a preferred location for global clinical trials, while maintaining the highest ethical standards for participant protection.
CTO is led and supported by the provincial community of stakeholders involved in clinical trials in Ontario. www.ctontario.ca
For more information:
Manager, Clinical Trials Ontario