This Is MS Multiple Sclerosis Community: Knowledge & Support

Today the CCSVI Coalition announced its Scientific Advisory Board (SAB). The advisory group of diagnostic, treatment and pathology experts has extraordinary insight into CCSVI and MS and a wealth of practical experience in assessing and treating people with CCSVI. They have been assembled to be an expert resource for researchers and government on these issues and to facilitate a balanced and open dialogue regarding CCSVI and MS.

The CCSVI Coalition Scientific Advisory Board of experts includes:
• Dr. Bill Code, Duncan, BC, Can - MD and chronic pain specialist
• Dr. Mark Godley, Vancouver, BC, Can - anaesthesiology, cross discipline medical interventions
• Dr. Sandy McDonald, Barrie, ON, Can. - Cardiovascular & thoracic surgeon; Dopler sonography protocols
• Dr. Mark Haacke, Detroit Mich, USA - Phd, MR research & MRV protocols
• Dr. David Hubbard, San Diego Calif., USA - MD, neurologist & sponsor CCSVI multi-centre registry
• Dr. Salvatore Sclafani, Brooklyn, NY USA, Interventional Radiologist; Intravascular Ultra Sound (IVUS)
• Dr. Gary Siskin, Albany, NY, USA - Interventional Radiologist; CCSVI safety co-author
Taken together, Drs. Sclafani and Siskin have performed over 400 CCSVI treatments as practicing Interventional Radiologists.

The Scientific Advisory Board is Chaired by Dr. Michael E. Shannon, an acknowledged expert in designing and running large clinical trials. He is well known to government and medical experts in Canada through his past positions as Deputy Surgeon General, Director General of The Laboratory Centers for Disease Control and Senior Medical Advisor to the Canadian Public Health Agency.

"We are delighted that there are to be CCSVI trials in Canada. This is an exciting new area of study that has aroused many hopes and much controversy," said Dr. Michael Shannon. "We wish to contribute constructively to the process of preparing an RFP for the Phase I/II trial for CCSVI and MS by offering our expert help to the Canadian Institutes of Health Research and Health Canada to make the trials the best they possibly can be."

I am so honored and pleased to have this opportunity to help the Canadian trials. Whatever they ask or need.

More specifically, I am talking about what is known as an adaptive Phase II/III trial which would permit a very rapid and seamless transition from the Phase II trial, subject of course to interim assessments of safety and efficacy, to a full Phase III trial. This would still address all the regulatory requirements, answering all the key safety and efficacy questions, but save significant time and cost.

So let’s talk about that framework or protocol for a moment. Putting together the protocol is probably the most critical process for any trial and requires highly experienced, well informed subject matter experts working collaboratively with clinical trial design specialists, statisticians and regulatory experts. Together they produce a document that defines in great detail every aspect of the trial, from patient selection to data analysis. Issues such as the number and type of patients are central to success. Determining what will be measured as an outcome must be carefully thought out with full agreement from all stakeholders. The determination of primary, secondary and tertiary outcome measures is essential if the real benefits of a treatment are to be fully appreciated. Finally, the actual therapeutic intervention must be made clear and in many cases, investigators need to be trained on the experimental procedure to ensure standardization. The intervention for CCSVI can be no exception.

Do you see this particular clinical trial as posing more than the usual challenges?

Yes I do. There are controversies regarding the most appropriate diagnostic approach. There is also a problem with the level of experience among Canadian investigators, which can only be resolved through proper training. But if we have no depth in this country, who will provide the training? It is noteworthy in this regard that many members of the CCSVI Coalition’s Scientific Advisory Board have had a great deal of experience with both the diagnosis and treatment of CCSVI. Most are very familiar with the treatment procedure and many routinely train other professionals.

Studies involving CCSVI intervention have proven very complex to interpret and the treatment presents some interesting challenges from a “blinding” perspective. Ideally, clinical trials should be double blinded, that is to say, neither the patient nor the investigator knows whether the actual treatment was received. Although both of these can be addressed using the concept of primary and secondary investigators, it will be a challenge to control.

Finally, I am somewhat concerned that the controversies regarding the role CCSVI may play in the pathogenesis of MS and the therapeutic merit of CCSVI treatment may have extended beyond the boundaries of healthy scientific debate. I think that everyone needs to humble themselves a little in the interest of good science and ultimately to realize the best possible outcome for our MS patients.