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Re: This is a must read for all forum users.

Posted: Thu May 19, 2011 8:51 pm
by drsclafani
1eye wrote:
drsclafani wrote:
Cece wrote: There's a risk taken with no benefit to the patient.
cece
there must be no coercion, patients must be treated with dignity and privacy, and they must be appraised of the risks

Patients do not have to choose to be a trial patient.
This one is one I know something about. There is an unspoken coercion by the implication that the trial is the only hope you have. That is emphasized, I believe, unethically, when it is given last as a treatment option. I think denial of treatments that have worked in the past to patients who plead for them, regardless of the doctor's expectation of them working, is unethical, and is used unethically as part of the coercion to trials which are much more interesting to the doctor than to the patient. I was swayed by the last argument, that I did not have to do anything. I was interested in the result. Like the doctor, I was just plain curious. What a situation to be in!
gary siskin's trial requiredd that patients have the option of treatment outside of trial in order for the trial to be approved.

Posted: Fri May 20, 2011 2:18 am
by DrCumming
Sal, are you aware of any of the details of the methodoloy sisken's trial? ie how is a jugular or azygous vein stenosis defined? what are the end points of treatment? etc.

Thanks for the thread

Posted: Fri May 20, 2011 2:40 am
by MarkW
Thanks for the thread everyone, really educational. I had been told that ethics committee approval was getting tougher........

drsclafani wrote:
1eye wrote:
drsclafani wrote:
Cece wrote:
codefellow wrote:
MarkW wrote:

I challenge the need to sedate patients (extra drug usage) just to attempt to blind patients...........not ethical.
MarkW

If patient gives informed consent for blinding and extra drug usage and knows he/she may not get actual treatment, where is the ethical breach?
Codefellow

There's a risk taken with no benefit to the patient.
Cece

there must be no coercion, patients must be treated with dignity and privacy, and they must be appraised of the risks
Patients do not have to choose to be a trial patient.
Dr S

This one is one I know something about. There is an unspoken coercion by the implication that the trial is the only hope you have. That is emphasized, I believe, unethically, when it is given last as a treatment option. I think denial of treatments that have worked in the past to patients who plead for them, regardless of the doctor's expectation of them working, is unethical, and is used unethically as part of the coercion to trials which are much more interesting to the doctor than to the patient. I was swayed by the last argument, that I did not have to do anything. I was interested in the result. Like the doctor, I was just plain curious. What a situation to be in!
1eye

gary siskin's trial required that patients have the option of treatment outside of trial in order for the trial to be approved.
Dr S

Trial Design Issues

Posted: Fri May 20, 2011 3:00 am
by MarkW
This a question to myself to ponder and for anyone thinking about designing a trial to think about.

A diagnosis of CCSVI syndrome in a trial is likely to need different treatments according to what is found (valve problems, webs, septa etc) and where (IJV, azygous, iliac etc). Clinical trial design tries to use just one treatment protocol (in order to reduce variation). These two trial goals are in conflict.

My thinking says that however carefully trials are designed and performed, they will be challenged by Neuros. They will say there is no double blinding, no real control arm, etc etc.

I still think the only way to overcome the Neuros is to conduct a very large number of open label trials (5000+). A few simple measures of changes need to be performed - cognitive fatigue measure ?? temperature of hands/feet ??

I am in a wonderful position, I can ponder and comment without having to deliver results.

MarkW

Posted: Fri May 20, 2011 3:08 am
by DrCumming
Mark,

Trial design is very complicated. Its even more complicated when you don't understand what you are dealing with, how to diagnose it, how to best treat it.

I am not sure I agree with your comments on the ethics of the sham procedure (however I am not an ethics expert). Without a sham arm, it will be hard to convince anyone that the procedure works.

As we see payment for the procedure dry up in the US, it will be easier to have patients in a trial as they will not have options unless they can afford to pay. That being said, it will also mean that the trials will have to find big $ to pay for them rather then the off budget research that is going on now.

Trial Design

Posted: Fri May 20, 2011 11:15 am
by MarkW
Dr Cumming wrote:
Trial design is very complicated. Its even more complicated when you don't understand what you are dealing with, how to diagnose it, how to best treat it.

I agree. I am not sure that there is sufficient understanding to design a trial. In drugs trials you have ascertained dosage form, dose, dose interval/timing information before you design a trial. Part of me thinks Neuros are tricking IR/VSs into trials before sufficent understanding of CCSVI is gained. Could that be deliberate by Neuros ??

Dr Cumming wrote:
I am not sure I agree with your comments on the ethics of the sham procedure (however I am not an ethics expert). Without a sham arm, it will be hard to convince anyone that the procedure works.

My concern about sham procedures for CCSVI is mostly about the sham arm not being sham (because of the patient is awake). A cross over design may help but short term (3 months) improvements must be measurable (complex in MS).

As I said, I have time to ponder..................

MarkW

Re: Trial Design

Posted: Fri May 20, 2011 4:39 pm
by 1eye
MarkW wrote: My concern about sham procedures for CCSVI is mostly about the sham arm not being sham (because of the patient is awake). A cross over design may help but short term (3 months) improvements must be measurable (complex in MS).
MarkW
A) people have to learn to stop that habit of using those two initials

B) I agree completely about the measureable, non-placebo-able improvements: temperature, cognition, blood pressure, flow rate, oxygenation, lesion burden, your pick, lots of others...

Do not worry that the tests are more invasive even than the procedure. People want the truth very badly.

Do not worry too much about shams for the same reasons. I think people realize the good they are doing, and that some faceless drug vendor is not the stakeholder here. It's us.

If people had to be offered DMDs alternative to the procedure, in order to be in a trial, you could not treat progressive patients from Canada, who are not prescribed DMDs as a rule. That sounds to me like more of the same Machiavellian manipulation that is making people suffer needlessly already. I hope that is not the case.

Posted: Fri May 20, 2011 5:10 pm
by Cece
A) people have to learn to stop that habit of using those two initials
Made me smile.

If I had no other options, in order to get the procedure, I would have participated in a sham trial. I am glad I had other options.