Of all the problems associated with electronic data capture (EDC), an investigative site's IT infrastructure has not been overlooked. Sponsors routinely try to assess clinical sites, talking to the staff of the investigator on the phone or sending a fax survey. The goal: discover if a prospective physician who wants to participate in a clinical trial has a Gateway PC, circa 1992, with a 9600 baud modem.
Now Scientific Software Tools Inc., of Media, Penn., has a better way. Via the Internet, for US$200, the company's Web-based applet can install itself on any PC and diagnose the computer's hardware, software, operating system and network connections. This can immediately tell a sponsor whether a particular clinical site has the basic technological wherewithal to participate in an EDC-based trial -- or not.
This largely removes the possibility of human error. Scientific Software's John Q. Griffith, director of sales at the company, notes that not all clinical staff may know how to swap out a bad hard drive: "Suzy, who comes in three days a week, is telling you that AOL is her operating system. The last patch that she saw was on the back of her kid's jeans."
eCliniqua checked out the company's Web-based, Active X-enabled tool. It's called Vista, which stands for Verifiable Investigative Site Technology Assessment. The software learned the following details about my computer: my user name; the clock speed of my Intel chip; total physical memory and available physical memory; file system type; available free space; browser version number; network connection speed; specific browser plug-ins (5) and scripting tools (3); specific patches for Windows 2000 (31).
Griffith is not at liberty to say which companies, but it sounds like two major sponsors of clinical research have used the Vista Web site to assure themselves that hundreds of investigative sites chosen for large, multicenter studies have the infrastructure to handle the technology used in a trial. In one case, handhelds were a key component.
Griffith says Vista can also troubleshoot once suitable sites have been chosen. "Suppose I'm using some sort of eclinical application at site #23 and it's been going fine for a few months," he says. "Now it's got a problem. I can run that machine through the assessment, take a look at the before and after and try to understand what's changed in the user environment that may be impacting the user experience."
This seems to be a potent instance of one technology supporting a decision to use a completely different technology. For as Griffith relates, some of the reluctance to use EDC comes from clinical trial sponsors getting less-than-accurate feedback from physician-investigators.
As Griffith tells me: "You've got some doc who has a pipeline right back into the sponsor, and he says, 'This application sucks. It won't do what I want it to do. I don't know what the problem is.' He throws his hands up. The sponsor's reaction is, 'Well, this EDC stuff doesn't work.' " In at least one such case, Griffith reports, the doctor in question had used one PC to get included in the trial -- and then switched over to a more antiquated machine to actually enter the data. "They were trying to use this 1995 PC on an AOL dialup account and were wondering why their page turns were terrible."
The Vista tool can be found at: http://www.vistasurveys.com/vista/VIST-1389.aspx