The agency plans to use new computer technology to simulate how some drugs in development are supposed to work, in hopes of identifying safety and effectiveness issues before late-stage clinical trials are completed, The Wall Street Journal writes.
Entelos, the biotech that developed the technology, claims this will allow researchers to obtain computer-generated test results in a matter of days or weeks, compared with years required for most major clinical trials. Far more “simulated patients” also can be tested than in conventional human trials.
Under an agreement with the FDA, three drugs now being studied for heart-related conditions in large human trials will be tested by the simulation technology, the paper writes, although the drugs involved in the project are not being disclosed.
The agreement is part of a broader effort by the FDA to get a bead on safety and efficacy, and to identify characteristics of patients that lead some to benefit from a drug while others are at risk of a bad outcome. A particular aim of the project is to see if simulated studies might indicate if the drugs could be linked to heart attacks and other cardiovascular events in cases too rare to be picked up in conventional clinical trials, the paper writes.
“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, tells the Journal.
He adds that regulators “wouldn’t make a decision to kill a drug based on a simulation,” but the findings could be used in discussions with drugmakers to influence decisions such as the design of clinical trials. Eventually such info also could affect prescribing information included in drug labels.
Both the FDA and drugmakers have used computer simulation in drug development, but have typically been limited to analyzing data generated in actual clinical trials, he notes. This project is different because it will evaluate drug data by plugging it into a virtual model of disease.
The effort follows controversies over Vioxx and the Avandia diabetes pill that were linked to increased heart-attack risk long after they were approved for the market. Merck withdrew the painkiller in 2004, while Glaxo’s Avandia remains on the market, the paper points out.
Entelos says its technology, called the Cardiovascular PhysioLab, uses a mathematical model to simulate how cholesterol functions in the human body and how deposits of fatty material called plaque develop in the artery walls and become prone to rupture, the Journal writes. By running certain chemical characteristics of drugs through the model, the hope is to be able to predict whether the compounds might cause cardiovascular problems and, if so, in what types of patients.
The program is “a flight simulator” for drug testing, Entelos ceo Jim Karis tells the paper. “What we’ve done is created underlying technology to mathematically represent human biology, and then you can do things to it to see what happens.” And guess what? He believes the program, which was finished in 2007, could have detected the issues that ultimately doomed Vioxx.
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