Human testing of new drugs and medical devices, known as clinical trials, used to be a blizzard of paper, requiring hundreds of data collection forms, reports and audits. Now, thanks to two University of Florida researchers, it's a blizzard of bytes.
"This is the first system that can do a complete, on-line, Internet-based clinical trial," says Mike Conlon, chief information officer for UF's Health Science Center and one of the system's architects. "It significantly reduces the amount of time and money that it takes to get research results from a clinical trial."
"The old system was really an archaic way to collect research data," adds Ron Marks, a UF biostatistics professor who designed the system with Conlon. "Every piece of data that was input had to be double- and triple-checked for accuracy."
Marks' and Conlon's system is now being marketed by their company, MarCon Global Data Solutions of Gainesville.
UF has applied for a patent on the technology and licensed the exclusive rights to MarCon.
The MarCon system employs powerful new Internet software like Java script to guide doctors at personal computers around the world through recruiting subjects for a trial and subsequent data entry. Doctors enter data directly into the on-line program as they are taking it from the patient.
"All previous systems have involved some transcribing of the records," says MarCon President and Chief Executive Officer John King. "This is the first time that we capture data electronically at the source and it becomes the official patient record."
The system will not allow ineligible patients to be entered into the trial, and it ensures that data are entered in a proscribed format so that it is "clean" from the beginning, Marks and Conlon say.
"This allows data analysis to begin as soon as the last patient in the trial is treated," they say, trimming an estimated six to nine months off the trial, delivering successful drugs to patients sooner and saving pharmaceutical companies millions.
The ability to track data as they are coming in also offers researchers an opportunity to react to any unusual trends in the study, Marks says.
"This real-time system provides an unprecedented safety net," Marks says. "If trial administrators start seeing an unusual number of adverse events at sites a world apart, they can stop the trial immediately."
Conlon, the computer programming expert, says the system employs extensive security features to restrict access to records and protect patient confidentiality.
"The Internet, properly used, is very secure," says Conlon, who adds that all data are encrypted using techniques similar to those employed by the U.S. Department of Defense.
Another benefit of the MarCon system is that it allows UF's Institutional Review Board (IRB), which oversees all research involving human subjects, to carefully monitor the recruitment of patients and ensure doctors are following proper protocols.
The massive International Verapamil SR-Trandolapril Study (INVEST) - originated by Dr. Carl Pepine, co-director of cardiovascular medicine at UF's College of Medicine - is the first large-scale application of the system. The trial, which compares the safety and efficacy of two common anti-hypertensive treatment regimens, is funded through a $16 million grant from the German pharmaceutical firm Knoll AG, manufacturer of the cardiovascular drug verapamil. More than 1,500 doctors will enroll 27,000 patients from 10 countries in the two-year trial.
"This study was uniquely suited to the strengths of our system, because it involved a large number of sites with a small number of patients at each site," Marks says.
"Even though Knoll AG was one of the last pharmaceutical firms to begin conducting this research, we believe our system will allow the company to be the first to finish."
For the INVEST study, the researchers decided to provide each participating doctor with a personal computer specially configured with all the necessary software already installed.
"We had two reasons for this approach," Marks says. "First, we felt doctors would be more willing to participate in an experimental approach if we offered them an opportunity to connect to the Internet as a bonus. Second, we wanted all the systems to be the same so we could more easily pinpoint computer problems when they arise."
Conlon says another benefit of the MarCon program is that it requires very little training.
"Doctors must gothrough a tutorial and register a hypothetical patient before they can enter their first real patient," Conlon says. "We have found this tutorial to be entirely adequate."
By January, the INVEST trial had 50 sites operating and was signing up 30 to 50 new doctors a week, Marks says.
MarCon's continued close relationship with theUniversity of Florida offers university a significant competitive advantage in its efforts to conduct other studies that involve collection and management of human subject data, Marks says.
"A leading drug company brought a whole team of its senior people down here to look at our technology," Marks says. "While they were here they had an opportunity to see the university's facilities and meet our faculty. And we learned what kinds of studies they're interested in pursuing."
In addition, UF's license to MarCon ensures the university maintains ownership of all future upgrades or improvements in the system.
King, a former computer systems executive with IBM, says representatives of five of the top pharmaceutical companies in the world already have looked at the MarCon system.
"They've all seen it demonstrated, and there seems to be a lot of interest," King says. "They are looking at our system as a technology that could revolutionize the conduct of clinical trials."
Related web site: http://invest.biostat.ufl.edu/