System provides nimble, efficient review of multi-centre clinical trials, while maintaining highest ethical standards
A new ‘streamlined’ approach for the ethical review and oversight of multi-centre clinical trials in Ontario was launched 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,” said Susan Marlin, President and Chief Executive Officer, CTO said at the launch of the new system.
A stakeholder-led organisation 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.
Reza Moridi, Minister of Research and Innovation, Ontario 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 the launch.
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 programme 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.
EP News Bureau – Mumbai