Clinical Trials for CCSVI and MS

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Clinical Trials for CCSVI and MS

Postby MarkW » Wed Dec 23, 2009 12:28 pm

I start with an apology for those who know this but to avoid mis-education I will post it anyway.

Nearly all drug trials (testing of a new medicine) are DOUBLE BLIND. This means that both the patient and the supervising physician do not know who is taking the active and who gets the placebo. The observations and tests by patient and doctor are made without any knowledge of who receives the active or placebo.
After all results have been recorded the study is UNBLINDED. Then the results are analysed to see if there is a correlation between the active drug and positive or side effects.

A study which uses an investigational technique (eg MRV/Doppler) needs to blind the investigator and if possible the patient. Take the Buffalo NY study as an example. There will be 1700 people in the study, of whom 1100 have MS. Obviously the study subjects know if they have MS or not. If the investigator is not allowed to talk to the subject then he or she is blinded. Study subjects will not be given results of their Doppler/MRV so they are also blinded in respect of the study.

Investigating the impact of anioplasty is far more complex to keep blinded as it is not ethical to perform angiolasty on subjects without blockages. However by having the investigators perform only one role (Doppler/MRV or angioplasty or patient review) a degree of blinding is achievable.

If I lost you along the away, sorry. Study design is a complex business. I am not an expert, just trying to avoid mis-information.......

MarkW
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 11 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html
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Postby ozarkcanoer » Wed Dec 23, 2009 1:43 pm

Blinded studies are good !! But it seems to me that when the study is unblinded, then the participants should be allowed to get their study results. What if a control was discovered to have a brain tumor ? Or some other problem that can be detected by MRI ? What if a person with MS is found to have severe stenosis ?

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Postby Johnson » Wed Dec 23, 2009 4:52 pm

ozarkcanoer wrote:Blinded studies are good !! But it seems to me that when the study is unblinded, then the participants should be allowed to get their study results. What if a control was discovered to have a brain tumor ? Or some other problem that can be detected by MRI ? What if a person with MS is found to have severe stenosis ?

ozarkcanoer

Hi ozarkcanoer,

In Canada, our Freedom of Information Act gives us the absolute right to review any files on ourselves (and have copies) that are not subject to national security restrictions. You probably have that same right in the US. I have always requested, and received copies of all MRIs, reports, etc., though, my last MRI (on CD) cost me $60! Coulda got the Beatles re-mastered box set and got some change back for that. Gouged!

If they saw a tumour in an MRI, that would have to be revealed immediately. They would just have to remove that file from the study. If it was something else, like a venous angioma, or such, it could probably wait a few months until the study was concluded, or again, remove that subject from the study.
My name is not really Johnson. MSed up since 1993
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Gold Standard Clinical Trials

Postby MarkW » Thu Dec 24, 2009 4:44 am

Hello ozarkcanoer,
Double blind trial are the gold stardard when designing a trial for an experimental compound (new drug). Every scientist reading a research paper will expect to see placebo controlled double blind trials, otherwise we would be wary of the results.
For drugs such as anti cancer ones, the new compund is often tested against the standard drugs for that type of cancer. This is because it is not considered ethical not to treat a patient with cancer.
The same approach has been used for experimental monoclonal antibodies (MABs) in MS. The MAB may be tested against B interferon for instance.

The protocol for a clinical trial will document what to do if trial subject has a different medical problem during the trial. Usually this involves removing the trial subject from the trial, unblinding their treatment and offering the best available treatment for the condition found.

When entering a trial you are asked to agree to the trial terms and conditions. This could include not having access to your diagnostic data from the trial.

My advice on this site has been for people with MS (pwMS) to get a MRV/Doppler performed (probably privately). Then you have access to the results and can lead the choices on treatment.

Happy Christmas,
MarkW
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 11 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html
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