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 participate.
- 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 used.
- Buying or renting equipment, clinic time, and/or extra space, as needed.
- Establishing a data and safety monitoring committee to provide oversight and feedback on any research or safety issues encountered.
- 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 visits.
- Gathering, merging and evaluating the data from all participants.
- 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.
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.