BUSINESSWEEK ONLINE : DECEMBER 11, 2000 ISSUE
BUSINESS WEEK E.BIZ -- SPECIAL REPORT An Rx for Drug Trials Drugmakers waste millions on antiquated methods for testing new products. The Web is changing that The specially built floor-to-ceiling shelves covering the wall in Edna Hutchings' office are crammed full of binders. Hutchings, a registered nurse at the University of Alberta Hospitals, has conducted some 60 clinical trials on new pharmaceuticals in the past decade. Most of them were done the old-fashioned way: clinicians laboriously recording clinical data on paper forms. One of Hutchings' current trials involves 20 patients, and by the time it is done, she says: ''I will have 60 binders per patient.'' Antiquated as this pen-and-paper approach may be, it is still used for 95% of the thousands of clinical trials started each year. It gobbles up time and money as well as shelf space. Drug-development experts figure that just cleaning up the mistakes in those binders takes up to six months. And for drugmakers, the process costs a million dollars in lost sales for every day of delay in getting an important new drug on the market. That's why a growing band of entrepreneurs and drug company researchers think there must be a better way. ''We believe there is tremendous power in the Internet to change the clinical-trial process,'' says Dr. Robert J. Spiegel, chief medical officer at the Schering-Plough Research Institute. Drug giant Schering-Plough (SGP) itself has teamed up with Waltham (Mass.)-based Phase Forward Inc. on systems that allow clinical investigators to enter patient data directly onto a Web site. By eliminating the time-consuming error-checking of paper records, ''we can shave one to two years off getting a drug to market,'' says Phase Forward CEO Shiv Tasker. Scores of other trials are now under way with technology from Cleveland-based Datatrak International Inc. (DATA) and PHT Corp. in Boston, two more leaders in the field. One of the beneficiaries is the University of Alberta's Hutchings. She is doing trials online for arthritis and osteoporosis drugs using Datatrak's software, which reduces her writer's cramp and makes her life a lot easier, she says. Datatrak's metrics show that the online approach cuts the total trial time by 30%. Despite the potential, however, online trials such as Hutchings' still represent a tiny faction of all trials, on which drugmakers spend about $20 billion each year. ''There is not really a market yet,'' says Datatrak CEO Dr. Jeffrey A. Green. ''There are no companies that are profitable yet, with revenues over $5 million.'' Why? Blame a conservative industry. ''It's often said that the pharmaceutical industry is 15 years behind in the uptake of technology,'' says Anne Wiles, executive vice-president of e-Business at Quintiles Transnational Corp. (QTRN) in Durham, N.C., which does drug development for the pharmaceutical industry. It's not for lack of interest, adds Quintiles CEO Dennis Gillings. ''But it's a bit chicken-and-eggish,'' he says. ''Everyone wants to see it work before they change.'' This conservative stance may be partly warranted. For one thing, developing workable technology isn't easy. The early systems required drugmakers to ship out dedicated laptops, often with cumbersome software, to every doctor in a trial. The Internet helps, but designing software that's speedy and intuitive is still a challenge. ''Everyone is waiting for a Quicken for clinical trials,'' says analyst C. David Hardison of the First Consulting Group. Big savings. And even the best software won't work if clinical investigators can't or won't get on the Web. Michael Conlon, the chief information officer at the University of Florida Health Science Center, ran into this problem when he and statistician Ronald G. Marks were setting up a huge heart-drug trial with 17,000 patients and 800 physician sites in 10 countries. ''The Web was the easiest part,'' recalls Marks. ''It was the contacts with humans that were the hardest.'' When it does work, the Internet offers dramatic savings. Recruiting patients over the Web can cost $35 per patient, compared with the $350 per person now spent on ads, phone calls, and other means, says First Consulting's Hardison. And once trials are under way, recording the data online can save months of effort. Paper records typically contain numerous niggling mistakes--blood pressures recorded on the wrong line or mysterious weight gains between patient visits. These aren't spotted until representatives from the trial's sponsor make treks to each site. ''The problem with paper is that it doesn't talk back,'' says Conlon. That's why it takes months just to clean up the paper data. In systems such as the one designed by Conlon and Marks, the software automatically checks the information being typed in, catching most mistakes. ''This is the wave of the future,'' says cardiologist Carl J. Pepine of the University of Florida, lead investigator of the 800-site trial using Conlon's software. To be sure, the Web can't speed up everything. After all, says Spiegel, ''if you treat cancer patients and need to find out how many survived after two years, you still need a two-year study.'' But even that could change as scientists learn enough about biology to accurately simulate the effects of an experimental drug in the computer. In some cases, preliminary trials could then be done in a few hours instead of taking months in real people. As the tide of new information technology begins to finally change the stodgy pharmaceutical industry, Edna Hutchings may have to find something else to put on her shelves. By JOHN CAREY Contributing: Ellen Licking _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ BACK TO TOP					e.biz Contents for Dec. 11, 2000 issue RELATED ITEMS An Rx for Drug Trials TABLE: Testing Drugs at Web Speed INTERACT E-Mail to Business Week Online

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