Hello All,
I've been asked to partake in a Phase III clinical trial. Would I be
able to see the results of the Phase I and II portions of the trial
before I signed up? I understand that the trial looks at results for as
long as 10 years and the trial is only 6 years old from the Phase I
part and would have only 'so called' partial data. Still I'd love to
see what Phase I and II have shown so far.
Thanks,
WhiteSoxFan
dr2354 - 31 Mar 2006 21:47 GMT
You should ask the provider about the results for the phase I and II
studies.
If you have the Trial identifier you MIGHT be able to find some additional
info on-line.
DanR
Bob Anthony - 01 Apr 2006 03:42 GMT
So called, shmocalled....it's BS.
Yes, do not parcipitate if they cannot provide at the very least some
information. Not too much to ask if you are indeed "parcipitating".
B.A.
Steve Jordan - 01 Apr 2006 03:45 GMT
> So called, shmocalled....it's BS.
> Yes, do not parcipitate if they cannot provide at the very least some
> information. Not too much to ask if you are indeed "parcipitating".
And if you're really really upset, don't participate, either. ;-)
Regards,
Steve J
Bob Anthony - 01 Apr 2006 15:44 GMT
Oops, damn spell checker again!! Thanks for pointing that out.
Participate, participate, participate, participate, participate....
I think I've got it! Thanks Steve.
B.A.
Steve Jordan - 01 Apr 2006 18:01 GMT
On April Fools Day, Bob Anthony responded to me:
> Oops, damn spell checker again!! Thanks for pointing that out.
Just having a little innocent fun.
Also, in some circles it's known as a spill chucker.
(snip)
Regards,
Steve J
Alan Meyer - 01 Apr 2006 07:26 GMT
> Hello All,
>
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>
> WhiteSoxFan
As I understand it, a clinical trial will normally result in at least
one publication that presents the results of the trial. I would
expect that any Phase I trial that is followed by a Phase II, and
any Phase II trial that is followed by a Phase III, would have
produced such publications.
Ask the doctors for information about them and see if they
can get you reprints.
If you know the NCI or other ID of the Phase III trial, you can
look it up in cancer.gov or clinicaltrials.gov (the former may have
more complete information if it's listed there.) You may find
citations to the results of earlier trials. If not, you will at least
find the names of the principal investigators. Use those name
to look for their publications in PubMed and you should find
anything they have published in the past.
Scientific publishing is a slow process, so some of the publications
might not be out yet. The article is written, then sent in for
publication to a journal. It might go to multiple journals, one
after another. The journals will send the drafts out for a review.
If the reviewers recommend publication, they might also point
out weaknesses in the article to the author, who will then revise
the article for another review. Finally, when all is ready, the
journal puts it in their publication pipeline - which might already
be full for many months. So it takes a while.
If the articles have not been published yet, it may be hard
to get solid information. The journals don't like authors
circulating pre-prints of articles that haven't appeared yet.
You'll have to be a little persistent to get all the information
you want, but I think you should be able to get some.
If you need help finding things, email me and I'll see if I can
help.
Good luck.
Alan
MAS - 03 Apr 2006 19:09 GMT
All trials result in a publication.
Before a next stage trial commences, a previous stage trial has been
published. Your Doctor will have that publication.
Mike
> Hello All,
>
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>
> WhiteSoxFan
PHD1993 - 05 Apr 2006 00:30 GMT
As a Clinical Pharmacokineticist (how the drug acts in the body) I have been
involved in numerous Phase I, II, III, and IV clinical trials. They do not
always result in publications.
However, it is common for results to be presented in some form somewhere.
Use the internet to search for the drug name (even the code name assigned by
the drug manufacturer) and see if you can find any entries. The Principle
Investigator (the doctor) must have received a document called an
"Investigators Brochure" which will contain all known information about the
drug. There still may be studies that have been completed in the clinic
that have yet to have an internal drug company report written - but the span
of time between the completion of the study and the drug company internal
Clinical Study Report (CSR) should not be over 6-12 months.
The previously mentioned web sites from National Cancer Institute and
Clinical Trials are good places to start looking.
If all else fails send me the drug name and I can see if I can find
anything - even a small chance I might have been involved with some other
study on the drug (OK, very, very, very small chance...)
Good luck,
Sam H.
> All trials result in a publication.
>
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>>
>> WhiteSoxFan