UF-Developed Software Means Paperless Clinical Trials, Quicker Cures

October 13, 1997

GAINESVILLE — University of Florida researchers have designed an Internet-based electronic computer system to bring large scale clinical trials into the world of cyberspace, saving time, money and maybe even lives.

The computer system will allow pharmaceutical companies to bring prescription drugs to the market faster, and successful trials can produce and deliver cures for patients more quickly.

“It significantly reduces the amount of time and money that it takes to get research results from a clinical trial,” said Mike Conlon, chief information officer for UF’s Health Science Center and one of the system’s designers.

The system, which allows clinical research to be done electronically, can trim six to nine months off the five years needed to complete a typical clinical trial. It eliminates the need to hand-check the data and shortens the lengthy process of finding and recruiting patients to serve as study subjects.

Researchers using the Internet-based electronic data capture system need less time to complete a trial, mainly because data is correct as soon as it is entered and is available immediately for analysis and review.

Past trial systems were strictly paper forms, which were time consuming and expensive. Extra time and manpower were essential to the process of checking all paperwork by hand. Even more recent trials still had paper forms that were then entered into a computer. The new system is paperless.

“Data is ready to be analyzed as it is entered,” Conlon said. “Statisticians are involved in trial planning and final analysis of data, which can now begin as soon as the last patient is treated in the trial.”

The new system also will speed up the process of subject recruitment by identifying ineligible patients before they are entered into a study. With direct Internet links, physicians can enter subject information into a database, and the system determines eligibility. The process omits possible patient errors written on eligibility forms.

In addition, physicians and trial mangers can check the electronic database form around the world with access to up-to-the-minute information. There is now real-time participation with the Institutional Review Board, regulatory agencies and sponsors. All participants are online and can see the study as it develops.

“That database is live and available to the study participants under appropriate security control,” Conlon said. “Everyone has improved access to trial data.”

System designer Ron Marks said the system is unique because all of the research is done over the Internet.

The initial run of the system began in early September with the International Verapamil SR-Trandolapril Study for UF cardiologists in the treatment of high blood pressure. Patient treatment will last two years. Nearly 1,500 computers worldwide are collecting data on an estimated 27,000 patients.

A patent for the system has been applied for, creating an opportunity for large-scale clinical research at UF. Development of the system will give UF researchers a competitive advantage in applying for studies in the collection and management of human subject data. The UF Division of Biostatistics also has been involved in the creation of the primary data collection system, which has been ongoing at UF for the last 13 years.