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Friday, May 11, 2012 9:20 PM | CCSVI in MS Toronto Volg link

With respect to clinical trials for chronic cerebrospinal venous insufficiency (CCSVI):

(a) what was the deadline for receiving applications for clinical trials for CCSVI and has the application process closed;

(b) how many applications were received, and, for each application received, (i) from what institution and country was it received, (ii) are the researchers who submitted the application practiced in the diagnosis and treatment of CCSVI;

(c) why was it decided that an international review panel was needed to assess applications for clinical trials;

(d) what was the specific process for and who was involved in choosing the members of the international review panel;

(e) who had the ultimate decision-making authority on the appointments to the international review panel;

(f) has the international review panel been chosen, and, if so, (i) who is on the panel, (ii) why was each member chosen, (iii) for each member, is he or she practiced in the diagnosis and treatment of CCSVI;

(g) how will all potential conflicts of interest of members of the international review panel be (i) recorded, (ii) confirmed, (iii) publicly declared;

(h) has the review process of applications begun,

(i) is it in progress, (ii) by what date is the review expected to be finished; (i) what specific criteria have been established to review applications;

(j) by what date is an announcement expected to be made regarding the chosen research team or teams;

(k) what, if any, monies have been set aside for clinical trials, (i) how was the required amount of money decided, (ii) will the monies allow for an adequate number of patients to be included to demonstrate clinical efficacy at the 0.05 level of significance;

(l) what timeline is being allowed for ethics approval;

(m) by what date is patient accrual expected to take place;

(n) by what date are clinical trials expected to commence; and

(o) what is a detailed timeline of what can be expected over the next year in terms of significant dates for clinical trials, as well as any dates for meetings regarding CCSVI?

Kirsty Duncan Etobicoke North, ON