RE: Reporting Modeling Results
Hi Steve,
I think it would be a good idea for you to cite the randomized studies
that back up your points in order to move this discussion forward.
When citing a number need to treat, we also need to consider the
actually cost of doing so. It's not that the staff in hospitals around
the world are not skilled, it's just that they are already very busy.
I'm trying to imagine a world where every hospital has a specialist
department for individually optimizing drug dosing for a wide variety of
drugs. What staff and equipment would it require? Are these staff
available? Would we require new procedures in the hospital to implement
all of the different drug protocols? What are the actual numerical
costs?
I am not asking these question rhetorically, I just think that this is a
very complex economic (rather than scientific) question and I would
value additional insight.
Best regards, James
James G Wright PhD
Scientist
Wright Dose Ltd
Tel: 44 (0) 772 5636914
www.wright-dose.com
Quoted reply history
-----Original Message-----
From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED]
On Behalf Of Stephen Duffull
Sent: 25 October 2007 23:53
To: 'Mark Sale - Next Level Solutions'
Cc: 'nmusers'
Subject: RE: [NMusers] Reporting Modeling Results
Mark, Nick
I think there are two issues here.
First,
> I would, of course, have to disagree that regulatory and
> marketing are minor shadows in the big picture - that is how
> new medicine come to improve health. I would suggest that
> better use of existing medicine is not much more than a minor
> shadow,
I think we may have to agree to disagree here. There is mounting
evidence in a variety of therapeutic areas that post-marketing
optimization of existing drug treatments by skilled clinical staff can
improve patient outcomes. Indeed, there is growing research that
indicates that the numbered needed to treat (NNT) may be in the order of
10-15 patients (i.e. treat 10 patients with optimized care on existing
drugs to save 1 additional event). This value of NNT is about as good
as any new drug is usually able to claim (treating AFib with warfarin
has an NNT of about 100).
So - I think the pre-marketing and regulatory aspects are as important
as the post-marketing clinical aspects. Clearly we need new drugs - but
we also need to use them better. And I don't think we can hope to learn
everything there is to know about a drug during the drug development
process.
Second,
> and while I think you're almost certainly right (as
> usual), I can think of only a couple of examples where this
> has been empirically shown that pk/pd informed dosing insight
> GENERATED AFTER APPROVAL is better.
There are also a growing number of examples where dosing that has arisen
out of PKPD studies, that were gained after marketing, has provided
significant patient benefits. We have seen this in patients who are
obese (and often not included in pre-marketing trials) and with a
variety of disease pathologies.
It is (for me) without question that industry, regulatory and academia
all play equally important roles in improving patient care.
Regards
Steve
--
Professor Stephen Duffull
Chair of Clinical Pharmacy
School of Pharmacy
University of Otago
PO Box 913 Dunedin
New Zealand
E: [EMAIL PROTECTED]
P: +64 3 479 5044
F: +64 3 479 7034
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