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. 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.
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.