Frequently asked questions on the work of the CIHR Scientific Expert Working Group

Scientific Expert Working Group Meeting
June 28, 2011
Toronto, Ontario

Q1: When will the pan-canadian clinical trial of chronic cerebrospinal venous insufficiency (CCSVI) take place?

A1: The Scientific Expert Working Group met on June 28, 2011 to review research related to CCSVI and multiple sclerosis (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.

Q2: What is a Phase I/II clinical trial?

A2: The Phase I/II clinical trial will assign human participants to the CCSVI procedure proposed by Dr Paolo Zamboni to evaluate the effects of this procedure on health outcomes.

In a Phase I trial, a small group of people is selected to evaluate the safety of the intervention. Phase II trials are performed on a larger group of patients and are designed to assess the efficacy of the intervention, as well as continue Phase I safety assessments in a larger group of people. The number of patients to be included in this study is not known at this time.

Q3: How can MS patients participate in the Phase I/II clinical trial?

A3: The team of researchers that will be selected to conduct the Phase I/II clinical trial will be recruiting patients 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 patients will be recruited and where the study will be conducted.

Q4: Will the Scientific Expert Working Group continue to monitor the results of the 7 studies?

A4: Yes. The studies have been funded for a period of two years and have been underway since the summer of 2010. The Scientific Expert Working Group will continue to monitor and analyze the data from the seven funded studies and other studies related to CCSVI and MS around the world.

The Scientific Expert Working Group will also hold a consensus workshop on ultrasound imaging to share information and determine a standard method for imaging the veins in the neck and brain that can be used in the seven ongoing studies and in the design of the Phase I/II interventional trial. A standard method will help ensure consistency and the comparability of the results of these studies.

Q5: When will the Scientific Expert Working be holding its next meeting?

A5: 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 in the first quarter of 2012 with a teleconference call in fall 2011.

Q6: What is the mandate of the Scientific Expert Working Group?

A6: The Scientific Expert Working Group monitors and analyzes the results from seven US and Canadian MS Societies funded studies, as well as from other related studies from around the world related to venous anatomy and MS. The working group is mandated to reach conclusions regarding: (1) a common standard for reliably diagnosing the proposed CCSVI condition using imaging or other techniques; and (2) a potential association between impaired cerebral venous drainage and MS. The working group will also make recommendations on further studies including, if appropriate, a pan-Canadian interventional trial that would evaluate the safety and efficacy of venous angioplasty in patients with MS.

Q7: Who are the members of the Scientific Expert Working Group?

A7: The Scientific Expert Working Group is comprised of the principal investigators and vascular experts from the seven studies funded by the US and Canadian Ms Societies, the scientific leadership from CIHR and the MS Societies of Canada, US and Italy, and other Canadian experts. See CIHR web link for members.

Q8: How were members of the Scientific Expert Working Group selected?

A8: The principal investigators and vascular experts from the seven studies went through rigorous reviews by an international review panel that included experts from various disciplines including interventional radiology, vascular surgery and neurology. The other international and Canadian experts were selected based on their clinician trial expertise, relevant research disciplines and research track-record.

Q9: Did the members of the Scientific Expert Working Group sign a declaration of conflict of interest?

A9: Yes, all members signed a declaration of conflict of interest at the last meeting of the Scientific Expert Working Group in June 2011.