"My argument here is how hard would it be to set up and run a clinical trial for this comparatively easy procedure
A get 50 MS sufferers
1) test to see if these MS patients have blocked blood vessels in the brain
2) perform procedure on the test group
3) see if any improvement over time 12-18 months
4) get feedback
5) publish results 2 years max "
Quote:
Originally Posted by dpastern
It wouldn't be hard at all Trevor. But doctors feed the pharmaceutical companies, and they like to make lots of money.
Dave
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I shake my head Mr Pastern, if you have something positive to say, go for it, if not you are displaying to the world your ignorance and angst on this issue, why bother
I am a medical researcher but not in neurological conditions. In my time I have seen many major breakthroughs in medical conditions both pharmaceutical sponsored and non-pharmaceutical company sponsored. I work with many researchers whose lives are devoted to discovering better treatments. Mr Pastern's comments are deeply offensive to me.
The difficulties of setting up a human intervention trial in Australia and most first world countries are enormous but not insurmountable. A well thought out scientifically sound and procedurally safe study will get through the many hoops to be registered with the TGA but then the logistics of procedural and study indemnity, having sites with expertise to collect the information and comply with GCP, approval from human research ethics committees etc are difficult. There is often an unrealistic expectation from those who are not involved in human research as to how easy it is to arrange. For those of us who are, patience and diligence (and funding) are the keys. Here is an idea of just 1 general document from TGA about doing trials on unregistered devices
http://www.tga.gov.au/docs/html/hrec.htm
For Trevor, don't be discouraged by the hurdles but keep an open mind about the possibilities. Unless a trial is already well advanced in the planning stages in Australia already it will take a long time to get going. You can check if there are similar trials going on currently in Australia by visiting this site
http://www.anzctr.org.au/