FDA will use computer tech to guide trial design

The FDA will deploy new computer technology from Entelos to simulate the activity of experimental medications so the agency can get an earlier read on the safety and efficacy of drugs in the pipeline. The Wall Street Journal reports that the FDA will announce the pact later today, highlighting how new computer simulations can be used to guide developers in the design of clinical trials. At a later point, the agency may also use the information it gleans to help define prescribing guidelines.

"What this study is about is trying to anticipate bad scenarios before they occur," Robert Powell, associate director in the office of translational sciences in the FDA's Center for Drug Evaluation and Research, told the WSJ. The new technology gives the agency a chance to better study the data gathered in a clinical trial by "plugging it into a virtual model of the disease." Entelos' Cardiovascular PhysioLab simulates the effect of cholesterol on the human body, illustrating the accumulation of plaque and likelihood of arterial rupture.

It also gives the FDA a better shot at heading off another safety fiasco like the one it experienced with Vioxx. And it's a big plus for the whole field of drug simulation technology, which has been wooing developers by touting its ability to look at how virtual humans will respond to a drug before they give it to living volunteers. The data is available in a matter of days and the FDA plans to start using it by focusing on the new drugs designed to treat cardiovascular conditions.

- read the story in the Wall Street Journal

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