Happy_canuk wrote:
UBC is only talking of doing angioplasty surgeries and, with a double-blind study, they will need to fake that part too.
I am not sure why this discussion is developing in this thread, and I am not a clinical trials expert, here is what we did at my last company and what I believe what will need to be done here(I think it is correct that sham surgery where the person in anesthetized and anything invasive is done would be unethical):
1. The patient had to first qualify as fulfilling the requirements of the test, i.e. be the right type of patient;
2. An envelope was selected from a number of randomly generated envelopes set up at the beginning of the trial that said either treatment or non treatment, and opened only after the patient had qualified. The ratio of treatment and non-treatment is set up at the beginning of the trial and isn't necessarily 50/50. In our case it was about 1/3 nontreatment, 2/3 treatment.
3. The treatment cases get the new treatmentl The non-treatment get the standard of care. If there is an established standard of care the patient's will always get that, both treatment and non-treatment, and the test results will compare the recipient's of both vs. just the standard of care. That is why in drug cases they are usually comparing a patient that recieves both A and B with a patient that recieves just A. A is usually the standard of care and the doctor won't treat the patient without providing at least the standard of care.
4. The results are blinded. In our case the results were radiographs at 3 months and 6 months, and the people who read and interpreted the results don't know what type of patient they are seeing, treatment or non-treatment.
You may remember that one of Zamboni's trials had the results blinded. All the x-rays from the 254 (?I am not sure) MS patients and all the results from the 600 ort so non-MS patients were shown to researcher's who didn't know, and they were determined to either have 1-5 stenosis. The results were still virtually 100% MSers had CCSVI and 0% nonMSer. Frankly that statistic was what absolutely convinced me.
Where there is no established standard of care and they are evaluating a new technique, as would be the case here, they compare the new treatment to historical data or those who chose non-treatment (which is not random but better than nothing.) In this case I speculate that different doctors will try different things and the results will be compared to each other and over time something will win out. That is what is already happening. Zamboni does veinous angiplasty, Drake was putting in stents, etc.
In case anyone is intertested, in my company's case the radiaologist swore they could tell the difference between testr and nontest with a glance at the x-rays, and the differnece was huge. When the results were unblinded it turned out there was no difference at all, statistically. The company (small start-up)failed and no longer exists. The system works.