"As you can see in this picture the original daclizumab trial was an open-label study, i.e. everyone gets treated with daclizumab and you simply count the number of gadolinium-enhancing lesions on MRI before and after treatment with daclizumab to assess whether or not the treatment is effective. At the end of the study the MRI images are assessed blind by a radiologist and the number of enhancing lesions are counted. This is called a bootstrap study. The MRI experts have now developed well defined protocols with power calculations, which allows us to use this type of study in early proof-of-concept studies. They are called bootstrap studies as MSers cross over from a period of observation to active treatment and they are not necessarily blinded. Bootstrap proof-of-concept studies are typical for academic or investigator-led studies because they are relatively cheap to perform (~$1.0-1.5M). Industry on the other hand prefers to do parallel double-blind placebo-controlled studies, which cost about 5-10x more. The table below is from the article that gives the numbers of MSers needed in these studies to get enough power to test whether or not a drug is effective or not."
We have talked about the need for randomized controlled trials but those are expensive and difficult to control. Perhaps what we need are more bootstrap trials where the patient is aware of the treatment but there is a blinded assessment at the end. The blinded assessment would have to be of the CCSVI, not the MS, wouldn't it? Anyway it seems there is a precedence in neurology for levels of evidence that are lower than RCT but still evidence.