How the Net Can Speed Drug TestingBy Perry Glasser | Posted 10-18-2002
The logistics of clinical trials to test new drugs are not the stuff for which Big Pharma companies are designed. Research, sure. Marketing, definitely. But maintaining painstaking records on the accuracy and legitimacy of double-blind experiments that can go on for more than a decade?
That's where new online clinical trial service organizations can help. Phase Forward Inc. in Waltham, Mass., and 1747 Inc. in San Francisco may be geographically split between the East and West Coasts, but the Internet has eliminated geography as a constraint to their core business: conducting clinical trials online for Big Pharma companies. Both have some venture capital money from Eli Lilly, but the pair claim independence from the Indianapolis-based drugmaker.
More than one voice has been raised in the U.S. claiming that FDA hurdles are too high and too frequently changed, but CEO Paul Bleicher of Phase Forward explains the historical origins of the FDA's notorious code for good clinical practices.
"In the 1930s, a hundred or so children were killed in a poorly run clinical drug trial," he says. "But the real impetus for the FDA came in the early 1960s when the drug Thalidomide was found to be the responsible agent for disfiguring birth defects." Thalidomide was administered to pregnant women to calm anxiety.
The firm 1747 is named for the year naval doctor James Lind of the HMS Salisbury, during experiments where he fed seawater, vinegar or citrus fruits to sailors, discovered how to avoid scurvy. The company's methodology is a bit more sophisticated that Lind's. In March 2002, 1747 wrapped up six months of trials of Lilly's Cialis, an erectile dysfunction drug Lilly expected to launch in 2002 as a competitor to Viagra. But due to manufacturing complications, its release is predicted no sooner than 2003.
Basically, subjects in the Cialis trial could, with confidence and privacy, report their results online via an electronic form rather than go to a doctor's office or clinic to fill out paperwork.
Naomi Fried, general manager and vice president for business development at 1747, says that 80 percent of clinical trials are delayed because subjects are hard to find. She says 1747 can cut the length of the recruiting process by 80 percent for big savings. Testing of two herbal compounds for sleeplessness and anxiety recently allowed 1747 to recruit 391 subjects in 45 states in a mere six weeksa proof-of-concept experiment for 1747 that demonstrated, says Fried, "a 13-week trial that without online methods might have taken a year."
Like 1747, data collected by Phase Forward is virtually paper-free. Bleicher reports that Phase Forward methods prevent data from being massaged by what Fried calls "overmotivated physicians."
The FDA requires that original data are maintained, filed and copied to compare with the data on file. "We supply a complete audit trail from application to the final analysis of all data changes," says Bleicher.
Best of all, instantly analyzed data quickly flags problems. If a survey question is somehow ambiguous, strange results will make themselves evident immediately and necessary steps can be taken to change the question's phrasingwithout days or months going by before being corrected. The same is true if a specific clinic has a recurring error.
"Knowing who did what and when, you can immediately calculate errors," Bleicher says.