Today the Government of Manitoba made the following announcement: Funding for MS Clinical Trials. You can read the news at http://bit.ly/gmZKHx
We are pleased that the Manitoba government has made multiple sclerosis a top-priority health issue. Scientifically relevant clinical trials in MS typically take place across a broad range of sites and if a nationwide clinical trial is to take place, the Manitoba and Saskatchewan projects will be helpful in ensuring this aim could be achieved.
Funding for MS Clinical Trials
On Tuesday April 5, 2011, the Government of Manitoba made $5 million available to the Manitoba Health Research Council (MHRC) to fund clinical trials for for treating Chronic cerebro-spinal venous insufficiency (CCSVI) in patients with Multiple Sclerosis. The funding builds on Saskatchewan’s $5 million for clinical trials and builds a complementary approach between the provinces to support coordinated multi-site trials that will strengthen the conclusions about the effectiveness of the procedure.
Saskatchewan was the first province to initiate clinical trials for the MS CCSVI procedure when it launched a call for proposals in December 2010. The Saskatchewan Health Research Foundation (SHRF) is managing the publically funded health research process and will release the outcome of the process soon.
MHRC will issue a call for proposals following consultations with SHRF to ensure proposal criteria and review processes are complementary.
MHRC will provide the money in stages to a top-quality research team to be chosen in a competitive grant review process based on accepted standards of science, ethics and clinical care. The MHRC will manage the grant funds according to our well-established grants management processes.
Information for Researchers: Application and Review ProcessFirst step - Expressions of Interest
MHRC will call for expressions of interest from members of the research community to indicate interest in mounting, or contributing to a clinical trial on the liberation procedure. The process and deadline for the expressions of interest will announced shortly.
Second Step - Expedited Call for Proposals
An expedited call for proposals will be based on sound evidence and best practices. A call for proposals typically outlines the scope of the research, funding available, timelines, application requirements, and criteria for success. MHRC’s goal is to issue a call for proposals in May.
Third Step – Establish an Expert Peer Review Committee
The committee will consist of about six researchers from across Canada. Possible areas of expertise to be included are neurology, vascular surgery, interventional radiology, rehabilitation therapies, and clinical trials design.
Fourth Step – Assess Proposals
The expert peer-review committee will assess all proposals submitted to MHRC in response to the call and provide its funding recommendation in summer 2011. MHRC expects to announce the outcome of the competition in fall 2011. The successful research team will include clinicians and scientists comprising expertise in designing and managing clinical trials, providing medical care for patients with multiple sclerosis, and leading a multi-disciplinary, multi-site research team. A portion of the research team will be from Manitoba. Team members will have a demonstrated record of excellence in their fields.
The actual start of clinical trials will depend upon the successful research team’s plan and timeline.
Information for: MS patients and their familiesMS patients and their families in Manitoba will play an important part in any clinical trials research project that is carried out by the successful research team.
The goal is to have a process in place for proceeding with clinical trials by late fall of 2011.
Until a successful research team has been announced, there is no list or requirement for patients to register their interest in participating.
Information about how interested patients may take part in any potential trials will be available after a successful research team has been announced. Your physician or other care provider will not have any additional information regarding your ability to participate.
Patients are encouraged to watch for updates and announcements in the summer of 2011.
Frequently Asked QuestionsWatch this area for updates and answers to commonly received questions.
When do you expect trials to begin?
The announcement is step one – financial commitment. We are not announcing what the actual clinical trials will be or when they will be, that will come later once a successful research team has been selected. Over the next few months the application and review process and deadlines will be defined.
Is Manitoba big enough to host a clinical trial?
There are many major research initiatives going on in Manitoba right now, led by excellent researchers based at our top-notch institutions. While we expect the team to include clinicians and researchers from Manitoba, this is a major project that could benefit from having researchers from other areas of Canada involved. This is the way successful research is often carried out today.
How many people do you need for a successful clinical trial?
Successful trials are built around outcomes and the research question being asked. While there is no set size, obviously a large enough pool of potential participants is necessary. We expect this to be one of many important questions that the expert panel will address when it crafts the call for clinical trial research proposals.
I have MS and I want to participate in the clinical trials, what should I do?
Keep watching this web site for more information. Until a successful research team is selected, we won’t know what that team’s process will be. There is no list to get your name on or any expression of interest required. When the successful research team is selected, that will be one of the things they will look after. The actual start of clinical trials will depend upon the successful research team’s plan and timeline.
Why does a patient have to wait maybe another year until the trials go ahead?
Developing scientifically and ethically sound research doesn’t happen overnight. Having a strong research process with clearly defined criteria, an expert panel, and a range of responses takes time.
We know there is great interest in the CCSVI procedure, but we have a responsibility to make sure that if clinical trials proceed, they are done in an expert fashion with results that can be used to better inform patients and health care providers alike about the MS CCSVI procedure.
We know there is great interest in the CCSVI procedure, but we have a responsibility to make sure that if clinical trials proceed, they are done in an expert fashion with results that can be used to better inform patients and health care providers alike about the MS CCSVI procedure.
http://bit.ly/gmZKHx