Comparison of simulated trials to real trials

From: mark.e.sale@gsk.com Subject: [NMusers] Comparison of simulated trials to real trials Date:Tue, 6 Aug 2002 13:21:38 -0400 Dear Colleagues, I'm look for examples where clinical trial simulations have been done, and the trials then done (as simulated), with both results published. An example is the (now famous) work by Mike Hale on Mycophenolate with the simulation published (as a technical report) and the actual trial results published (van Gelder T. Hilbrands LB. Vanrenterghem Y. Weimar W. de Fijter JW. Squifflet JP. Hene RJ. Verpooten GA. Navarro MT. Hale MD. Nicholls AJ. A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation. 68(2):261-6, 1999 Jul 27) for comparison. There seem to be a few abstract: we have one presented as an abstract. "A method to assess congruence of a clinical trial simulation and a phase II clinical trial" There also were two abstracts by Peck et al at ASCPT 2000 ("PK/PD modeling of moxonidiena and simulation of a phase 3 trial" and "Simulation of Clinical Trials: Lessons Learned"), and one full paper (Kimko HC. Reele SS. Holford NH. Peck CC. Prediction of the outcome of a phase 3 clinical trial of an antischizophrenic agent (quetiapine fumarate) by simulation with a population pharmacokinetic and pharmacodynamic model Other examples? Thanks Mark Sale M.D. Global Director, Research Modelling and Simulation Clinical Pharmacology and Discovery Medicine GlaxoSmithKline