RE: WRES AND OUTLIER IDENTIFICATION/EXCLUSION

From: Michael.J.Fossler@gsk.com Subject: RE: [NMusers] WRES AND OUTLIER IDENTIFICATION/EXCLUSION Date: Tue, 26 Sep 2006 09:47:39 -0400 Hi Leonid; I have to point out that you are mixing up "outliers" with bad data. The two are not the same. Errors in the data should be tracked down and corrected, but these are not outliers. Outliers are data points that do not fit your "priors" of how the data should look. I still maintain that excluding data based on the fact that they don't fit into your pre-conceived notions of how they should look is a bad idea and should not be done. I'm not sure I agree with you about the relative quality of Phase 3 data. Electronic point-of-care data capture is definitely minimizing these kinds of errors (If not, why are we doing it?). Also, thorough training of nursing staff will go a long way toward minimizing mistakes. I'd argue for more of that and less outlier exclusion; I'm not sure I'd want to go to the FDA and say, "well, you know Phase 3 data, always full of errors, this is the best we can do." I have an idea of what the response would be to that... Mike ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Michael J. Fossler, Pharm. D., Ph. D., F.C.P. Director Clinical Pharmacokinetics, Modeling & Simulation GlaxoSmithKline (610) 270 - 4797 FAX: (610) 270-5598 Cell: (443) 350-1194 Michael_J_Fossler@gsk.com ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~