Re: Pharmacoeconomic simulations

Pete, The best paper I know is by Hughes et al - see below with abstract Hughes DA, Walley T. Economic evaluations during early (phase II) drug development: a role for clinical trial simulations? Pharmacoeconomics. 2001;19(11):1069-77. Abstract Faced with increasing demands on demonstrating cost effectiveness, pharmaceutical companies are required to conduct pharmacoeconomic evaluations throughout the drug development programme. At present, there is particular emphasis in the literature on burden-of-illness studies and on economic evaluations conducted alongside phase III clinical trials but not on those conducted during phase II clinical trials. This article describes modelling techniques, namely clinical trial simulations (CTS), which are gaining popularity in the clinical research community, but which might also prove to be beneficial during the conduct of these early pharmacoeconomic evaluations. The basic concepts and structure of CTS are described by using published examples of simulations of antipsychotic and anticancer drugs. With the use of an illustrative example of a hypothetical cholinesterase inhibitor for Alzheimer's disease, an integrated CTS-based pharmacoeconomic evaluation is presented. The results demonstrate how the modelling may be of value in 'go/no-go' decisions during the drug development programme. Regards, Jeff Jeffrey S. Barrett, Ph.D. Research Associate Professor, Pediatrics Director, Pediatric Pharmacology Research Unit, Laboratory for Applied PK/PD Clinical Pharmacology & Therapeutics Abramson Research Center, Rm 916H The Children's Hospital of Philadelphia 3615 Civic Center Blvd. Philadelphia, PA 19104 KMAS (Kinetic Modeling & Simulation) Institute for Translational Medicine University of Pennsylvania email: [email protected] Ph: (267) 426-5479 >>> "Bonate, Peter" <[email protected]> 4/23/2009 10:37 AM >>> Is anyone aware of any papers or abstracts using computer-assisted trial design that incorporates a pharmacoeconomic component to the simulation? Or any pop pharmacokinetic-pharmacodynamic papers that include the same? Thanks Pete bonate Peter L. Bonate, PhD, FCP Genzyme Corporation Senior Director Clinical Pharmacology and Pharmacokinetics 4545 Horizon Hill Blvd San Antonio, TX 78229 USA [email protected] phone: 210-949-8662 fax: 210-949-8219 crackberry: 210-315-2713 "Beware of geeks bearing formulas". Written by Warren Buffet as part of Berkshire Hathaway's 2009 Annual Report to Stockholders. BEGIN:VCARD VERSION:2.1 X-GWTYPE:USER FN:Barrett, Jeffrey ORG:;Clinical Pharmacology EMAIL;WORK;PREF;NGW:[email protected] N:Barrett;Jeffrey END:VCARD