FAQ on MS Society of Canada-Funded CCSVI Studies
MS Society of Canada
June 11, 2010

The MS Society of Canada has funded four projects. The total value of all projects is $700,000. Additional research projects will be considered in future research grant competitions administered by the MS Society of Canada.

All research applications underwent a rigorous expedited peer review process by an independent international review panel that included experts drawn from all key relevant disciplines including: neuroradiology, neurovascular imaging, MS imaging, vascular surgery, biostatistics, interventional radiology, interventional neuroradiology, and MS clinical neurology. The review panel used the Canadian Institutes of Health Research (CIHR) common scale for scoring. The MS Society of Canada and the U.S. National MS Society worked collaboratively to assemble the reviewers who considered scientific merit, responsiveness to the international request for applications, experimental design, likelihood of producing definitive data, and the experience of the applicant teams. The leadership of the Canadian and U.S. MS Societies followed the panel’s recommendations and undertook the funding of these studies.

Availability to participate in studies will be limited. It’s expected that participants will be recruited from existing patient rosters at MS clinics associated with the funded projects. Inclusion in studies may depend on a number of factors including: age, type of MS, geographic location, previous treatment history, patient status at an MS clinic and other medical conditions to name a few. The MS Society of Canada plays no role in selecting participants or determining the process of how participants are selected.

The MS Society’s role in this research is as a funder and as such will receive an initial six-month report as well as a one-year interim report from each of the funded studies. The MS Society will post on its website summaries of interim or peer-reviewed results as they become available. Please note, the MS Society of Canada plays no role in selecting individuals to participate in studies.

These studies are not designed to treat CCSVI but rather to understand the prevalence and significance of the condition as it relates to MS, and to identify the best imaging technology to evaluate it. These are critical steps toward a better understanding of the relationship between CCSVI and MS disease process.

The MS Society has committed to advancing this research through the funding of these four research projects. This is in addition to the $8 million the MS Society expended on research during the past fiscal year. The May 5 request to the federal government was made to urge the government to do its part. The MS Society feels strongly that the federal government has a role to play in advancing research on this front as some Canadians have gone overseas and have paid out-of-pocket to get the testing and procedure done in other countries. By funding research on a large scale, the federal government can both advance research and provide safeguards to those seeking diagnostics and treatment.

The studies are two years in length and researchers expect to publish results in peer reviewed scientific journals as outcomes are established. The timing of data analysis, peer review and publication can vary widely and thus it is not possible to predict when results will be available. However, in addition to a one-year interim report, researchers will be asked to provide an initial 6-month update to the MS Society on their grant progress from the date of funding. The MS Society of Canada will post information as it becomes available.

Projects were assessed by an independent international review panel using the Canadian Institutes of Health Research (CIHR) common scale for scoring. Considerations for not receiving funding might include issues such as research design, feasibility of research proposal, and outcome measurements. See also question 2 for additional factors.

There is a long and well established convention in the administration of scientific research funding programs that only successful awards are made public. This is a professional courtesy to the investigators who did not get recommended for funding. Researchers who have not been successful in this competition are invited to bring forward applications in subsequent competitions.

Pending acceptance of awarded grants, it is expected that funds will flow to institutions as early as July 1, 2010. From there, timing will vary by project. Considerations include acquisition of institutional or ethics review board approval, administrative infrastructure and development of recruitment and participation protocols.

The new projects take a comprehensive look at the structure and function of veins draining the brain and spinal cord in people representing a spectrum of MS types, severities and durations, and compare them to the structure and function of veins in people with other diseases and healthy volunteers. The studies incorporate accepted high standards of experimental blinding and controls designed to provide unbiased results.  They also use a variety of imaging technologies including the Doppler ultrasound technology originally used by Dr. Zamboni’s team.

Together, these studies aim to further understand the role of CCSVI in MS and identify optimal methods for screening for the condition, which would be necessary to determine the next steps required in advancing this CCSVI lead.  They will also be of value in designing protocols for possible therapeutic trials that might be independently undertaken in North America or abroad.