New medications and medical procedures must undergo clinical trials before they can be certified by the FDA. The gathering and processing of trial data, as well as the general administration of the clinical process, can be both time-consuming and error-prone. Our goal is to reduce the time and administrative burden placed on researchers by providing them with a computerized method of tracking and reporting these data consistently, freeing them to perform more research. We will develop a PC-based, user-friendly software system that allows individual researchers to customize CRF'S, collectdata automatically via telecommunications from trial sites, and perform validity checking, statistical analysis, and reporting. Existing systems are expensive, often deviate from evolving industry standards, and provide incomplete solutions. The Phase I effort will define the features and functions of the final system, identify appropriate existing software packages to integrate as components, specify new software, and prepare an initial prototype.Awardee's statement of the potential commercial applications of the research:There are no adequate and affordable PC-based clinical trials software packages on the market. The system will be accessible to end users, not only to programmers, and will provide all necessary functions through a single integrated user interface. The system will expedite the clinical trials data acquisition, entry, and analysis process-particularly by collecting data automatically from remote sites via telecommunications. It will shorten the time for research results to be accepted by the FDA.National Cancer Institute (NCI)
