June 27, 2014
MS Society of Canada Collaborates with CIHR in Call for CCSVI Clinical Trial Research Proposals
The Honourable Leona Aglukkaq, Minister of Health, and Dr. Alain
Beaudet, president of the Canadian Institutes of Health Research
(CIHR), announced today that CIHR is ready to accept
research proposals for the Phase I/II clinical trial on chronic
cerebrospinal venous insufficiency (CCSVI). The request for
research proposals will be available on CIHR’s website on
November 30, 2011. The request for research proposals is a
collaborative initiative between the CIHR and the MS Society of
Canada. CIHR will also continue to work with the provinces and
territories as it moves forward with this initiative. The MS
Society of Canada has committed funding towards the financial
cost of a clinical trial.
CIHR will announce the successful research team in March 2012. The selected team will then need to obtain ethics approval from relevant institutional research ethics board(s) before conducting the trial.
In general, the involvement of people in research (a clinical trial) is highly regulated by the Canadian government and requires a number of additional steps over a laboratory study. Some of the main steps include:
- Defining the overall purpose of the study, ensuring financial
resources and/or finalizing funding agreements to support the
study, and seeking out new collaborations with various experts
who haven’t necessarily worked together before.
- Developing a detailed protocol or blueprint of the study’s
design including exactly what to study, how, with what number of
participants and for how long. This step is particularly
important as a poorly designed study has no scientific value and
is therefore a misuse of time and funds. The specific step by
step procedures for each part of the study are essential to
ensure that each participant undergoes the same protocol and that
the information obtained is scientifically useful.
- Developing one or more “Informed Consent” documents. These
describe the study in detail, including what will be done at each
step and the risks and benefits of participation in the study.
Patients must be fully informed of all of this information, have
the opportunity to ask questions, be free from coercion regarding
participation and sign the consent form if they wish to
- Applying for approval to begin the study from a Research
Ethics Board (Canada), including approval of the Consent Form and
other plans. This step is required by the government to ensure
adherence to guidelines related to the protection of human
subjects in research.
- Hiring staff needed to conduct the study, and ensuring staff
are trained in the protocol and any relevant techniques to be
- Buying or renting equipment, clinic time, and/or extra space,
- Establishing a data and safety monitoring committee to
provide oversight and feedback on any research or safety issues
- Recruiting and screening participants that meet the study’s
criteria and obtaining their informed consent.
- Conducting the study, including performing scanning, clinical
evaluations and other data collection. Some protocols require
repeated scans or additional scans, meaning additional clinic
- Gathering, merging and evaluating the data from all
- Communicating and publishing results.
The MS Society of Canada is hopeful that the trials will deepen
our understanding of the CCSVI treatment theory and give the MS
community the definitive answers that we all seek. The MS Society
of Canada will continue to monitor all developments related to
CCSVI. Visit ccsvi.ca for the most up-to-date information. For an
FAQ on Phase I/II clinical trials, please visit: www.ccsvi.ca/en/pdf/ClinicalTrialFAQ.pdf
For more information about how the MS Society helps people affected by MS by funding cutting-edge research, bringing about change through advocacy, and providing programs and services to people with MS and their families, go to www.mssociety.ca.