Clampdown On Clinical-Trial Costs

Pharmaceutical companies pay a high price to develop new drugs, including conducting the lengthy clinical-trial process required by the Food & Drug Administration to ensure product safety. It costs about $800 million to develop a prescription drug, a recent report from the Tufts Center for the Study of Drug Development says. A big part of the problem is that clinical-trial information is often scattered throughout a number of different systems, making it difficult for clinicians to get a complete view of the data.

Oracle, Pharsight (which specializes in software for the pharmaceutical and biotechnology industries), and PricewaterhouseCoopers said last week that they'll begin working on a data repository product that will make it easier for pharmaceutical-industry employees to find and analyze the trial data they have accumulated. Companies that better understand the research early in the process can more easily contain costs by reducing the number, size, and complexity of clinical trials of promising products, as well as more quickly pull the plug on drug failures. Lowering development costs could be a boon not only to the drug companies but potentially to health-insurance providers and consumers, who are pushing for lower prescription-drug prices.

The packaged software and services, which aren't due for more than a year, are expected to include Oracle's 9i database, Discoverer, Reports, Warehouse Builder, and Workflow products, as well as Pharsight's Clinical Workbench, Knowledge Server, and Trial Simulator software.

The Trial Simulator software, which creates mathematical models for managing data that simulates drug performance based on different variables, also cuts costs by reducing the number of human participants needed for a clinical trial.

Using software to simulate drug performance also can shave time off a process that can take anywhere from eight to 15 years, says Mike Pavia, chief technology officer for Millennium Pharmaceuticals Inc. in Cambridge, Mass. The $196 million company conducts research and development for Bayer, Abbott Laboratories, and American Home products.

Clinical-drug trials are typically conducted in the same time-and resource-intensive way that automobile crash tests were mainly handled 15 years ago, before carmakers began using simulation software. "Car engineers built a prototype and smashed it against a wall. Then they would look at where the damage was and create a new prototype," Pavia says.

There's another clear need for a package such as this, Pavia says. Understanding clinical-trial data is expected to become more complicated as human genome research progresses. Drugs on the market today are designed with knowledge of only about 500 of the 40,000 genes within the human genome. "We've only scratched the surface," Pavia says.

IBM, which expects its new life-sciences unit to be a $7 billion business by 2004, is also busy establishing a foothold in the market for clinical-trial technology. IBM disclosed last week that it's sealed a deal for its global-services unit to host data capture, clinical research record keeping, patient tracking, and reporting software from Phase Forward Inc.