Implementation of clinical trials to assess new treatments involves collection and processing of formidable amounts of patient data. Currently, well over 90% of all primary patient data collected in clinical trials is recorded using paper forms, thus imposing numerous fundamental inefficiencies and costs. Computerization of clinical trials has been largely limited to enrollment tracking and various database processing operations. Computerized acquisition of physician-administered, structured interview and rating processes is more complex, especially for rating scales that require entry of multiple data types (e.g. written text, analog scales, check boxes). The project objective is to develop a solution for computerization of the patient interview process in clinical trials at the point of contact. The proposed system would be the first of its kind to replace paper forms in face-to face clinical rating interviews, support entry of multiple data types and mark the introduction of several new technologies into controlled clinical trials of antidementia compounds, including the tablet PC. Advantages of computerization include: immediate electronic capture of written interview narrative; computer-based review of and flexible access to stored electronic forms through a powerful, fully relational database; automatic generation of case report forms; and automated project reporting and documentation. The clinical interview data acquisition system will include a standardized assessment interview instrument as well as ancillary software utilities to assist implementation and management of clinical trials, including those required to meet FDA guidelines. In Phase I, the comparability, technical utility and user acceptability of the system will be determined in both simulated and live patient interviews.
