DEVELOPMENT OF A CLINICIAN'S INFORMATION SYSTEM

THE RESEARCH PROPOSED IS TO INVESTIGATE THE FEASIBILITY OF WRITING A SOFTWARE PACKAGE FOR PERSONAL WORKSTATIONS THAT WILL HELP CLINICAL RESEARCHERS AND THEIR ASSISTANTS CARRY OUT THE DESIGN, DATA COLLECTION, DATA STORAGE, AND FORMAL AND EXPLORATORY ANALYSES OF CLINICAL TRIALS. THE PURPOSE OF SUCH SOFTWARE WILL BE TO ASSIST THE SINGLE RESEARCHER OR THE SMALL GROUP DOING SMALL- TO MODERATE-SIZED TRIALS. TOOLS WILL BE DEVELOPED THAT ARE EASY TO USE AND TIME EFFICIENT; THEY WILL PROVIDE A FRAMEWORK SIMILAR TO (BUT MORE POWERFUL THAN) THE PAPERBASED SYSTEMS RESEARCHERS TYPICALLY USE. THE TOOLS WILL 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 REQUIRING MORE ASSUMPTIONS. TOOLS WILL ALSO BE INCLUDED TO DESIGN (OR EVALUATE THE DESIGN OF) CLINICAL TRIALS USING CLINICALLY UNDERSTANDABLE PARAMETERS, SUCH AS PERCENTAGES ORHYPOTHETICAL CURVES AS INPUT, WITH REGARD TO SAMPLE SIZE ANDSTATISTICAL POWER.