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By DON LONG
Healthcare InfoTech Managing Editor
What happens to clinical trial data? That’s what drug and device companies and certainly the Food and Drug Administration must ask themselves when checking the reliability of clinical trial information, especially when that information doesn’t seem to add up.
But it’s a question that now can be answered easily and quickly with the PlexxNet Patient LogPad from PHT (Boston), to be rolled out at next week’s annual meeting of the Drug Infor ma tion Association in Baltimore.
The device is designed to take most of the paperwork out of clinical trial work so that, rather than a paper trail of clinical data, companies can produce a clean, clear, online trail to maintain continual quality control. This, in turn, will speed their products through difficult regulatory hoops. The problem with paper data, according to Jim Becker, chief operating officer of PHT (which stands for Personal Health Technology), is "degradation," meaning, "all the things that can happen to paper as it passes from hand-to-hand." He told Healthcare InfoTech, "Humans are inherently error-prone," a fact that creates a large margin for losing information and recording data incorrectly, possibilities which are compounded each time paper moves from one hand to another.
That problem becomes even larger when you consider the stakes a total of $2.5 billion spent on clinical trials, a figure Becker predicts to explode to at least $5 billion in just a five-year period.
PlexxNet provides a solution by allowing electronic input of patient data with a device so compact that it can be held in the hand. With the PlexxNet LogPad technology, information can be input either by physician/clinicians or by patients themselves. The data gathered can begin with patient enrollment and then be collected throughout the entire trial continuum including analysis through to transmission to the FDA via its new electronic data collection processes. "The system tries to eliminate as many transcription steps as possible," says Becker, while also providing an ongoing opportunity for "edit-checking" for errors as it moves throughout the data continuum.
The initial version of the company’s PlexxNet technology comes in two versions, an Investigator logpad and a patient logpad, the latter allowing the clinical trial participant to record his or her own data, such as symptoms, drug or device use and other significant elements required by the protocol. By allowing patient input, the patient logpad provides additional levels of accuracy in collecting trial information. Besides helping to increase patient involvement in the trial, the logpad is interactive, allowing nurses or other clinicians to observe data input in real time and contact the trial participant if data isn’t entered appropriately, a problem that often crops up in paper diaries, Becker notes. "It’s a matter of taking attendance, you might say," says Becker. Trial participants "learn they’re being watched every day, and if they don’t provide the data they hear about it quickly."
PlexxNet is currently being used by one Big Pharma company and another smaller firm, Stan Erck, president and CEO of PHT, told Healthcare InfoTech. And its rollout at next week’s DIA conference will mark a foray into broad distribution. Erck reports that PHT was formed as an incubator company in the mid-1990s and completed development of the PlexxNet system late last year with the help of institutional and "angel" investor funding that totaled approximately $3.5 million. The company is developing a second round of financing that will take it through the year 2000 and hoped-for profitability.
The PlexxNet LogPad system has met the FDA’s guidelines for electronic data capture and transmission, and the company has also developed the PlexxNet Clinical Network, a web-based system for data capture, data management and trial management. The network thus completes and complements the continuum of data accuracy, a cycle that too often breaks down and slows a product's path to commercialization, according to Stephen Raymond, PhD, co-founder and chief scientist for the company. Raymond says that the primary concept of PlexxNet technology is to validate data accuracy with the study subject. "The PlexxNet LogPad raises the bar," he says, "be cause it ensures that patients report information every day and enables researchers to begin evaluating data the instant it is transmitted."