Mr. Speaker, with regard to milestones and the reporting process in the Canadian MS clinical trial supported by the Canadian Institutes of Health Research as queried in questions (a), (b), (c), (d), (n), and (r), the Canadian MS clinical trial supported by the Government of Canada is taking place in four sites across the country: Vancouver, Winnipeg, Montreal, and Quebec City. The trial led by Dr. Anthony Traboulsee from the University of British Columbia started on November 1, 2012; two sites, Vancouver and Montreal, received ethics approval in 2012, and the other two sites received ethics approval from their research institutions by February 2013.
The four teams have met on a regular basis to ensure harmonization of the protocol among the sites. Protocol training, ultrasound technician training, and interventional radiologist training took place at the four sites over the course of 2013 and were completed by September 2013.
The recruitment of patients has started at the four sites and is expected to be completed over the next year. In all, 100 patients are expected to participate in the trial.
In August 2013, Dr. Traboulsee announced that researchers had been able to assess approximately 50 patients to determine whether they have the CCSVI condition and that procedures had been done on fewer than 10 patients.
It is important to note that the study is a double-blind study. In other words, neither the subjects of the experiment nor the persons administering the experiment know the critical aspects of the experiment. This process is important, as it guards against both experimenter bias and placebo effects. In this context, the researcher team will be unable to analyze and share preliminary data before the study is completed.
Dr. Traboulsee expects to reach final conclusions on the safety and efficacy of the CCSVI procedure by 2016. It is expected that the results of this study will be published in peer-reviewed journals. Under CIHR’s open access policy, researchers awarded CIHR funding are required to ensure that all research papers generated from CIHR-funded projects are freely accessible through the publisher's website or an online repository within 12 months of publication.
As indicated in the request for applications, the principal investigator will have to submit a final report to CIHR. He is also required to submit annual progress reports.
With regard to the protocol and funding of the MS clinical trial as queried in questions (e), (f), (g), (h), (i), (j), (k), (l), (m), (o), (p), and (q), funding of the $6 million study over four years is a collaborative effort of CIHR, the MS Society of Canada, and the provinces in which the trial will take place. The Provinces of British Columbia, Manitoba, and Québec and the MS Society of Canada have each pledged $500,000 towards this clinical trial.
Details regarding the funding opportunity developed by CIHR to support a phase I/II MS clinical trial, including the selection criteria, are available on CIHR’s website.
The proposals submitted to CIHR for the funding opportunity were rigorously evaluated by a panel of international experts. The panel recommended supporting the application submitted by Dr. Anthony Traboulsee, which ranked first in the competition.
It is important to note that all of the 100 MS patients participating in the trial will receive the CCSVI procedure at some point. During the first year of the trial, half of the patients will receive the CCSVI procedure, while the other half will undergo a placebo procedure. In the second year, MS patients who received the placebo procedure in the first year will undergo the CCSVI procedure, while those that received the CCSVI procedure in the first year will undergo the placebo procedure. MS patients participating in the double-blind clinical trial will be monitored over a two-year period. Specific questions regarding the protocol of this independent research project or the cost of the clinical procedures should be addressed directly to the principal investigator of the study.