Numbers game

The average FDA approval process is long and expensive, and only one of every 5,000 compounds ever makes it to market.

Part of the problem with the process is that most pharmaceutical companies’ idea of high-tech reporting is filling out paper forms that eventually make their way to three-ring binders.

“In an average FDA study, there are about 98,000 pages of paper generated,” says Dr. Jeffrey Green, president and CEO of DATATRAK International Inc. “When the study is completed, those pages fill up a semi truck … and once the FDA sifts through, they have to store all of that in a warehouse.”

But word on the street is that even the director of the FDA is fed up with maintaining warehouses of binders. At a recent conference, he told the heads of the top pharmaceutical companies to start “getting comfortable with new technology.”

Cue in Green and DATATRAK’s software for the electronic collection, transmission, review and storage of clinical trial information via the Internet.

DATATRAK is one of a handful of companies vying for this burgeoning market, and with a contract that involves 3,000 patients at 350 research locations in multiple countries, it’s one of the leaders.

“With approximately 10,000 clinical trials initiated annually, sponsors spend $12 billion processing investigative data,” says Green about the potential of the clinical testing market. “We believe our market share could be about $4 billion in size.”

Beyond ridding the FDA of huge amounts of paperwork, electronic data capture (EDC) can facilitate getting much-needed drugs to market faster and more cheaply.

“Our product reduces overall time of the study by 30 percent (from eight years to five years) … and it improves the quality of the data by 85 percent,” says Green.

The custom program also reduces the number of queries the FDA has regarding data sent from doctors, which can number 100,000 per study.

“Do you know how many pregnant male patients come up in these studies?” Green says.

He refers to it as dirty data, which can happen with a simple check in the wrong box.

“With our system, the software talks back to you and says, ‘This is an incorrect answer … it corrects the problem instantaneously.'”

Information is stored on the Internet, accessible to any doctor involved in the study and recorded in real time.

“If you’re a doctor and you have patient with a problem, you can sit in front of a computer screen and go through the data,” says Green. “All the doctor’s office or hospital needs is a 20K speed Internet connection.” How to reach: DATATRACK International Inc., (440) 443-0082