RE: Reporting Modeling Results

-----Original Message----- From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED] On Behalf Of Stephen Duffull Sent: 29 October 2007 20:21 To: 'James G Wright'; 'nmusers' Subject: RE: [NMusers] Reporting Modeling Results James I had hoped we would move on :-) > As you are holding up this enoxaparin work as a generalizable example, It is just a single example - there are many others. > I think your bold claims merit at least a token > challenge. When I review academic studies, the first thing I check for > is patients who are excluded from the data analysis. I am absolutely astounded that you consider academic studies in a more critical light than industry driven studies. Shouldn't all studies be taken on their merit - or are you suggesting that academic studies are naturally flawed in some way? > Did excluding these 4 subjects alter the results of the trial? Simply the patients were removed before analysis. They did not meet protocol requirements (e.g. some received unfractionated heparin). It is my best belief that if we continued to recruit patients that we would see the same signal as the trial found. The trial was adequately powered so we are not expecting bias inherent in underpowered studies (compare to the underpowered APPROVe study wrt CVS observations). In addition, the purpose of this part of the thread, for me, was to show that a) studies do arise in academic settings that improve patient care [to respond to Mark's comments] and b) that simplifying the dosing on the drug label to make the drug "easier to use" doesn't necessarily result in better patient outcomes. 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