Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
San Francisco Chronicle - The Voice of the West, 901 Mission Street, San Francisco, CA 94119 - Tuesday, March 25, 1997 - Page C3
Peter Sinton, Chronicle Senior Writer
Pharsight, of Palo Alto, said its Trial Designer software could cut the time it takes to bring new drugs to market, save manufacturers millions of dollars and reduce the number of human "guinea pigs" needed for conventional trials.
Under today's agreement, a North Carolina subsidiary of London-based Glaxo will use Pharsight's software to conduct "virtual clinical trials" before deciding whether to commit huge sums of money toward developing drugs.
On average, it takes eight to 12 years and more than $360 million to bring a new drug to market, and clinical trials account for about half the time and one-third the cost.
Computer technology is used extensively to help design airplanes, semiconductors and even certain areas of drug development, such as discovering useful compounds. But until now it has not been used to design human clinical trials.
Right now, a new drug goes through an average of 64 trials before it is submitted to the Food and Drug Administration, but up to one-half of the trials fail due to poor design or unclear results.
Glaxo Wellcome figures that using Pharsight Trial Designer software will help it increase both the efficiency and likelihood of success of its drug testing.
"For example," said Glaxo clinical pharmacology manager Keith Muir, "we can synthesize data from early development studies of a new drug with information from previous trials on similar compounds to forecast the results of a clinical study in advance."
Pharsight's software is hardly a shrink-wrapped product that you would find for $79.99 at a computer store. It is likely to cost $1 million or more. However, Pharsight figures that its technology might save a company six months and millions of dollars.
Because about 25,000 clinical trials are conducted worldwide each year -- each one involving 10 to thousands of participants -- new computer modeling techniques also could spare many thousands of human guinea pigs.
"We're injecting science into the clinical trial process," said Pharsight co-founder and Vice President Camilla Olson."The goal is to get product to market faster, save money and expose fewer patients unnecessarily to speculative drug testing."
Scientific Consulting of Apex, N.C., and MGA of Concord, Mass., are two other companies working on computer modeling to assess the impact of new compounds on the human body and other aspects of clinical trials.
970325
SC970314
Copyright © 1997 - San Francisco Chronicle Press. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the San Francisco Chronicle, Permissions Desk, 901 Mission Street, San Franciso, CA 94103. You may also send a fax to (415) 495-3843, or an email message to chronperm@sfgate.com. http://www.sfgate.com.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.
Always watch for outdated information. This article first appeared in 1997. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 1997. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .