Are you ready for Virtual Clinical Trials?

By Daniel R. Matlis 

The Kaiser Permanente Northern California Division of Research announced yesterday, February 14 2007,  that it is launching one of the largest research projects in the United States to examine the genetic and environmental factors that influence common diseases such as heart disease, cancer, diabetes, high blood pressure, Alzheimer’s disease, asthma and many others.

The goal of the Kaiser Permanente Research Program on Genes, Environment and Health (RPGEH) is to discover which genes and environmental factors are linked to specific diseases.

During the Press Conference David Kessler, former commissioner of the U.S. Food and Drug Administration and current dean of the University of California at San Francisco School of Medicine (UCSF), commented: “Increasingly we are moving into a world of personalized medicine. What does that mean? Right person, right disease, right drug and right dose”

Researchers hope to explain how genes and environmental factors work together to influence the risk of getting a disease or affect its severity or outcome. The Research Program will also include studies of genetic and non-genetic factors that affect how people respond to specific medications, including the occurrence of side effects.

Cathy Schaefer, PhD, director of the RPGEH and a research scientist at the Kaiser Permanente Division of Research in Oakland, added “Our research could help us identify not only what diseases a person may be at risk for, but also identify how to reduce that risk, or how best to treat the disease. This research program provides an exciting opportunity to make significant progress toward improvements in health and medical care.”

The RPGEH initiative represents a major step towards virtual, life-long clinical trails and personalized medicine.


Imagine the level of knowledge researchers and healthcare practitioners will gain from running clinical trials in-silico based on the data gathered by projects like RPGEH.

We would all benefit from safety and efficacy profiles that are orders of magnitude more precise than those available today. Product testing would shift from clinical trials run on 5-10 thousand volunteers to trials run on millions of virtual volunteers based on real people and the environmental condition surrounding them.

This level of knowledge does not come without its problems. To address security and disclosure issues, Kaiser Permanente said that participation in the RPGEH is completely voluntary. Individual’s genetic information will not be used in genetic studies without their written consent. Furthermore, no research data is stored with identifying information.

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