All clinical trials conducted in Canada, including phase IV trials, must follow good clinical practices, which include:
- having a sound research protocol
- obtaining the informed consent of all research subjects
- obtaining research ethics board (REB) approval of the trial and enabling its continued oversight
- ensuring investigators and staff have the appropriate qualifications
- monitoring and reporting serious, unexpected, adverse drug reactions
- maintaining accurate records.
Approval from both Health Canada and the REB at each clinical site must be obtained prior to the initiation of any clinical trial.
Research ethics boards
Canada has a stellar reputation for safety and for protecting patients who participate in clinical trials, in large part because of the quality of the country’s health system and the ethics review process, which includes the participation of REBs across Canada.
REBs are tasked with protecting trial participants, balancing the risks of research with the need to conduct it, and balancing the potential harms with the potential benefits.
However, when multiple REBs are tasked with reviewing the same clinical trial, the landscape for the trial sponsor can become confusing and complex. Trial sponsors may be faced with multiple forms and policies, and multiple protocols overseen by multiple people and organizations, each with very different requirements—yet all of them have the exact same goal. The consequence is time, cost, delay and, potentially, frustration and mistrust.
Current system a barrier to multi-site research
Several important reports, such as the 2013 report produced by the Streamlining of Health Research Ethics Review (SHRER) External Advisory Committee, have put forward recommendations to improve multi-site ethics review.
The SHRER report recommended greater harmonization and standardization of REBs. It also developed models for common elements, such as application forms and adult consent forms, to facilitate streamlining efforts.
In 2015, the CCTCC Research Ethics Board Accreditation Working Group was established to identify strategies to improve the efficiency of ethics reviews so as to reduce unnecessary confusion and complexity while maintaining safety and oversight. In a report published in August 2016, the REB Working Group made seven recommendations that it believes can advance the development of a national coordination mechanism relatively quickly, and for relatively low cost.
One key recommendation is to establish a national registry of the REBs that review and approve trials. This registry could be incorporated within the Canadian Clinical Trials Asset Map, and Health Canada is currently investigating the feasibility of this approach.