The research proposed is to investigate the feasibility of writing a software package to run on personal workstations that would help clinical researchers and their assistants carry out the design, data collection and storage, and formal and exploratory analyses of clinical trials, and to implement such software if its design and performance are attractive. The emphasis of such software would be to assist the single researcher or the small group doing small to moderate sized trials. The tools would be chosen to be very easy to use and very efficient of the clinician's time, and would provide a framework similar to (but more powerful then) the paper-based systems such researchers typically use. The tools would emphasize acquiring the highest quality data via data management methods specific for the clinical investigator, and using various graphical and """"""""exploratory"""""""" analysis methods that substitute computer-intensive techniques for classical techniques that require more assumptions. Tools would also be included to design (or evaluate the design of) clinical trials with regard to sample size and statistical power, using clinically understandable parameters such as percentages or hypothetical curves as input.
