Archimedes to Develop Computer Model of Obesity Clinical Trials for FDA
Model will pit benefits against cardiovascular risks and specifically look at Abbott's Meridia trial.
Archimedes entered into a research collaboration agreement with the FDA to develop a computer model of clinical trials evaluating weight loss medications. The model will be used to obtain a better understanding of the benefits of weight loss drugs against the long-term risks of cardiovascular outcomes.
Specifically, the model will attempt to reproduce the results of the Sibutramine Cardiovascular Outcome Trial (SCOUT), which showed that patients receiving sibutramine were 16% more likely to suffer serious cardiac events than those who received a placebo. Sibutramine was marketed as Meridia by Abbott Laboratories but was pulled from the market last year after the cardiovascular risks became obvious.
Archimedes will build and validate the clinical trial model using published data from the SCOUT trial, patient information from the National Health and Nutrition Examination Survey, and information about physiological pathways and disease symptoms in the targeted patient populations. The model will then be used to explore possible outcomes over a 10-year simulated extension of the trial.
The company's technology, called Archimedes Model, is a full-scale simulation of human physiology, diseases, behaviors, interventions, and healthcare systems that utilizes mathematics, computing, and data systems to represent human physiology and the effects of diseases. At the core of the model are a set of ordinary and differential equations that represent physiological pathways and the effects of diseases, tests, and treatments. Whereas statistical models such as Markov models describe associations between small numbers of variables, Archimedes says that its model describes the underlying causal relationships of systems of physiological variables.