Frequently Asked Questions - Multiple Sclerosis - Systematic Literature ReviewQ1: What are the conclusions of the recent CMAJ publication on multiple sclerosis?
A1: The meta-analysis published by Dr. Laupacis and his collaborators suggests a statistical relationship between multiple sclerosis (MS) and chronic cerebrospinal venous insufficiency (CCSVI). However, as the large variation in the results do not allow definitive conclusions to be drawn, the authors consider that more high-quality studies are needed to determine definitively whether CCSVI is more frequent in individuals with MS as compared to those without MS.
Q2: How will the federal position on MS/CCSVI be affected by the conclusions of this new article?
A2: The federal position to conduct a Phase I/II clinical trial on the CCSVI procedure was partly based on the draft results of this new publication.
On June 28, 2011, the draft results of the literature review conducted by Dr. Laupacis were presented to the CIHR Scientific Expert Working Group, along with data related to CCSVI presented at international meetings. Based on this scientific evidence, the Scientific Expert Working Group recommended that CIHR support a Phase I/II clinical trial on the CCSVI procedure.
On June 29, 2011, based on the Scientific Expert Working Group' recommendation, the Minister of Health asked CIHR to establish the terms of reference for a Phase I/II clinical trial involving individuals with MS.
The Scientific Expert Working Group will continue to monitor and analyze the data from seven MS Society-funded studies and other studies related to CCSVI and MS around the world.
Q3: How inclusive was the systematic literature review conducted by Dr. Laupacis?
A3: This systematic review conducted by Dr. Laupacis focused on studies published in the peer-reviewed literature. Dr. Laupacis and his collaborators undertook an extensive literature search of peer-reviewed publications, with no language restrictions, to identify eligible studies published up to June 2011.
Q4: When will the pan-canadian clinical trial of CCSVI take place?
A4: The timing is not determined at this time. The Scientific Expert Working Group met on June 28, 2011 to review research related to CCSVI and MS. Following the meeting, Dr Alain Beaudet, President of CIHR, advised the Minister of Health, the Honourable Leona Aglukkaq, that members of the Scientific Expert Working Group agreed that a Phase I/II clinical trial should proceed. On June 29, 2011, the Minister of Health asked CIHR to establish the terms of reference for the Phase I/II clinical trial.
CIHR will be working over the fall with its Scientific Expert Working Group to develop the terms of reference for the trial and will then select, through a competitive and rigorous peer-review process, a research team to conduct the clinical trial.
Q5: What is a Phase I/II clinical trial?
A5: In a Phase I trial, a small group of individuals with MS is selected to evaluate the safety of the intervention. Phase II trials are performed on a larger group of individuals and are designed to assess the efficacy of the intervention, as well as continue Phase I safety assessments in a larger group of individuals. The number of individuals with MS to be included in this study is not known at this time.
Q6: How can individuals with MS participate in the Phase I/II clinical trial?
A6: The team of researchers that will be selected to conduct the Phase I/II clinical trial will be recruiting individuals with MS once they have received approval on their research protocol by their Institutional Ethics Review Board. It is not possible to know at this time how many individuals will be recruited and where the study will be conducted.
Q7: When will the Scientific Expert Working be holding its next meeting?
A7: Members of the Scientific Expert Working Group agreed to meet every six months to monitor and analyze any new results from the seven MS Society-funded studies and any other related studies. It has met in November 2010 and June 2011 and will hold its next meeting late this fall.
For further details about the systematic review, please refer to the CMAJ publication entitled: Systematic review of the association between chronic cerebrospinal venous insufficiency and multiple sclerosis.
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