?the dose-concentration-effect relationships for the drug.The main motivation for developing computer simulations for clinical trials is cost-reduction. Currently, research and development costs for drug are estimated to be around $1 billion US dollars, the majority of which was associated with the conducting of clinical trials. Clinical development accounts for about 30% of the cost and 50% of the time (7.2 years) necessary to bring one new drug through approval of the Food and Drug Administration (FDA).One of the main causes for such high costs of clinical development is that clinical trials often have flaws in design and have to be repeated. Clinical trial simulations can be used to reduce the risk of failure of a clinical trial. They can be used to identify weaknesses or limitations in a proposed study design, so the design can be improved prior to implementation of the actual clinical study.Currently, there are a few commercial simulation software products dedicated to simulation of clinical trials. They include Pharsight Trial Designer, ACSL Biomed, Entelos and Archimedes. Archimedes, in particular, has been used to evaulate and to design clinical trials for diabetes and heart diseases. It is a complex, integrated model that brings together many aspects of the health care systems. Many pharmaceutical companies develop in-house software for simulation of clinical trials. The FDA has recently accepted simulation results as part of the evidences provided by pharmaceutical companies in their applications for new clinical trials.The Use of Advanced Computer Simulations in Clinical Drug Trial Management
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