RE: Reporting Modeling Results

-----Original Message----- From: Stephen Duffull [mailto:[EMAIL PROTECTED] Sent: 26 October 2007 19:57 To: 'James G Wright'; 'Mark Sale - Next Level Solutions' Cc: 'nmusers' Subject: RE: [NMusers] Reporting Modeling Results James, Mark I don't have time to go through all RCTs in this manner. But I will provide a single recent example that I was involved with. For Mark, the special population was obesity and renal impairment. In both situations a continuous dosing scale was used rather than the recommended "cut-off" value idea (i.e. change dose if CLCR < 30ml/min) ... All studies were performed in academia, post-marketing, without industry support * Background study (model for LBM): Janmahasatian et al. Clin PK 2005;44:1051-1065 * PKPD studies: Green et al BJCP; 2002:54:96-103 & Green et al BJCP 2004;59:281-290 * Clinical study: (an RCT individualising dose to LBM) Barras, CPT 2007 [advance online publication 10 October 2007] NNT: 4-8 (to reduce adverse outcomes) Requirements, a dose calculator or nomogram to calculate LBM (see background study), Cockcroft and Gault formula to calculate CLCR (based on LBM). Otherwise limited impact on already busy clinical pharmacy services. There are other examples (but I'm marking exams right now) but I'm sure others can comment here too. 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 Design software: www.winpopt.com > -----Original Message----- > From: James G Wright [mailto:[EMAIL PROTECTED] > Sent: Friday, 26 October 2007 10:22 p.m. > To: 'Stephen Duffull'; 'Mark Sale - Next Level Solutions' > Cc: 'nmusers' > Subject: RE: [NMusers] 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 > > > -----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 > > Design software: www.winpopt.com > >