Archimedes, FDA collaborate to develop computer model of clinical trials evaluating weight loss medications

Jan 20 2011

Archimedes Inc., a healthcare modeling company, announced today that it has entered into a Research Collaboration Agreement with the U.S. Food and Drug Administration (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 against the long-term risks of cardiovascular outcomes in patients treated with weight loss drugs.

“We are excited about the collaborative work we are conducting with the FDA to further understand the effects of weight loss medications in a population of 'virtual' patients”

The computer model will attempt to reproduce the results of the Sibutramine Cardiovascular Outcome Trial (SCOUT), which showed that patients receiving sibutramine were 16 percent more likely to suffer serious cardiac events than those who received a placebo. The model is expected to provide insight into the relationship between patient outcomes and cardiovascular risk factors such as blood pressure, heart rate and cholesterol. The model will then be used to explore outcomes over a 10-year simulated extension of the SCOUT trial.

"We are excited about the collaborative work we are conducting with the FDA to further understand the effects of weight loss medications in a population of 'virtual' patients," said David Eddy, M.D., Ph.D, founder of Archimedes, Inc.

Archimedes will build and validate the clinical trial model using published data from the SCOUT trial and patient information from the National Health and Nutrition Examination Survey (NHANES), a widely known and validated program of studies designed to assess the health and nutritional status of adults and children in the United States. The model will also include information about physiological pathways and disease symptoms in the targeted patient populations.