Clinical Trials for CCSVI and MS
Posted: Wed Dec 23, 2009 11:28 am
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
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