Have your say and help design a clinical trial? #MSBlog #MSResearch
"In view of the current interest in HSCT I have made a first attempt at designing a trial to ascertain whether or not HSCT (hematopoietic stem cell transplantation) is non-inferior to alemtuzumab. The latter is the only realistic way of powering the study. For this to be developed into a protocol each section needs work. Any volunteers? It also needs a name; I have come up with ZEUS, but as with all community-designed trials I think we should have a competition with a vote to name the trial. Therefore suggestions are welcome."
"I assume a lot of of you will still disagree with the need for a comparator trial; I think it is essential. Without data from at least one, and preferably two, well-designed phase 3 studies the MS community, the regulators and the payers won't accept HSCT as a treatment for MS."
"Some of you will say that HSCT is too risky and that this proposal is crazy? I would have said so myself, until a week ago; the recent poll on this site about risk and HSCT has made me reassess my position. It is clear that MSers are much more willing to take risks than I realised. There is one caveat; MSers who follow this blog are unlikely to be representative of the wider MS community."
"Finally, at some point in time we will need to assess the wider communities appetite for a trial of this nature; without buy in from a larger group of people this study even as a fledgling concept is going nowhere. We can do some quantitative and qualitative work once we have a workable trial protocol in place."
Labels: Alemtuzumab, BMT, Clinical Trials, head-2-head, HSCT, ZEUS Trial