Hi,
I recieved a few answers to my question about clinical trials:
From Phil Mc Shane:
I think you have to treat that as an endpoint, not a dropout.
What is this wonderful surgical treatment anyway?
From Dave Andrae:
You may check into the oncology literature. New oncology treatments,
sugical, chemotherapy, or other, tend to plan around the issue you are
seeing. That is, that denial of the new therapy is avoided by designing
a single-arm study and comparing results against historical controls.
These types of studies, however, are typically used to plan for large
randomized double-blind or placebo controlled trials (ie, Phase III
type).
A lot will depend on where the research program is in its development
and the overall goals of the current trial.
From Sue Richards:
If the method is new and there is a lack of information on its effectiveness,
although it might theoretically be better, then it would be ethical to deny
surgery. If the trial is ethical, then it must be true that there is doubt
about
whether surgery is better. If this was a new drug, rather than a procedure, it
would not be allowed to be used until tested. However, if the politics does
not
allow the withholding of surgery, then the only option might be to think of
the
trial as a comparison of 'early' versus 'delayed' surgery. Whether this is
worth
doing will depend on the details of your particular trial.
From Vicky Ryan:
I am about to embark on a similar trial where standard tmt is compared with
a prophylactic antibiotic which has no down sides and hence we may have
similar problems - we may not even get patients in the trial with proper
informed consent!
--------------
Thak you all! I will now sort this out together with the medical staff.
About the surgical method which Phil was interested in: - I have to
ask, and come back to you.
Yours sincerely
Göran Granath
My original question:
>Date: Mon, 12 Sep 2005 21:01:28 +0200
>To: [log in to unmask]
>From: Goran Granath <[log in to unmask]>
>Subject: Problems in clinical trial
>
>Dear all,
>
>We have a considerable problem with dropouts, if you can call them so. - A
>clinical trial is being conducted where one half is treated in the
>traditional way with medication and the the other half is treated by a new
>surgical method. Apparently the new, surgical, method is very popular
>among the patients as, after half time, almost 50% wanted to stop
>medication and get surgery instead. The problem is that the medication
>group becomes far too small but for ethical reasons it seems difficult to
>deny surgery.
>Anybody experienced something like this before?
>
>Thank you in advance
>
>Göran Granath
>
>Goran 'Joe' Granath, PhD Phone: +46-18-30 16 67
>Ariadne Exploration AB E-mail: [log in to unmask]
>Malma Ringväg 1
>S-756 45 Uppsala
>Sweden
Goran 'Joe' Granath, PhD Phone: +46-18-30 16 67
Ariadne Exploration AB E-mail: [log in to unmask]
Malma Ringväg 1
S-756 45 Uppsala
Sweden
|