March 4, 2015 – A new ‘streamlined’ approach for the ethical review and oversight of multi-centre clinical trials in Ontario was launched today by Clinical Trials Ontario (CTO).
The CTO Streamlined Research Ethics Review System allows any single ‘CTO Qualified’ research ethics board in Ontario to provide ethical review and oversight on behalf of multiple research sites involved in a clinical trial.
The current approach in Ontario has been to conduct a research ethics review at each and every research institution participating in the same clinical trial.
“The CTO Streamlined System provides a timely, efficient and effective approach for reviewing multi-centre clinical research in Ontario, while maintaining the highest standards for participant protection,” CTO President and CEO Susan Marlin said today at the launch of the new system.
“This is a tremendous opportunity to enhance the environment for conducting multi-centre clinical trials in Ontario,” said Marlin.
A stakeholder-led organization established by 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: “Ontario is an ideal location for clinical trials because of our leading researchers and clinicians, established networks and high-quality research infrastructure. Now, with a new streamlined approach for ethical review and oversight, Ontario will be an even more globally attractive place to conduct clinical trials.”
Clinical trials play a crucial role in advancing medical knowledge, enhancing the health of Ontarians and advancing our innovation economy through direct investments in research facilities and job creation.
The Council of Academic Hospitals of Ontario (CAHO), which represents the province’s 24 research hospitals, added its voice of support and partnership at today’s launch. CAHO’s Chair, Leslee Thompson, 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 congratulate Clinical Trials Ontario on this achievement and express our support for the new system.It is the intent of our 24 member hospitals to use it.”
The CTO Streamlined System can be used for both industry-sponsored and investigator-initiated multi-centre clinical trials and health research.
All research ethics 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. The qualification process is important as it allows institutions and research ethics boards to feel confident delegating ethics review and oversight to each other.
In recent months, several research ethics boards in Ontario have become CTO Qualified. One of those boards is already reviewing a newly submitted clinical trial protocol. Facilitating the process is a web-based electronic 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. It will improve the speed and reduce the costs of doing multi-centre trials, while maintaining the highest ethical standards,” 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.”
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