CLINICAL PROGRESS OF STUDIES

THE PURPOSE OF THIS RESEARCH IS TO USE THE RESULTS OF PRIOR RESEARCH AND DEVELOPMENT BY DEDICATED RESPONSE ON GENERALIZED DATA MANAGEMENT SYSTEMS, ALONG WITH THE SYSTEMS ANALYSIS AND DATA ENTRY SOFTWARE AVAILABLE FOR MINI - AND - MICROCOMPUTERS. THE PROJECT WILL CREATE A DATA PROCESSING TOOL KIT. THIS SET OF TOOLS SHOULD REDUCE DRASTICALLY THE TIME AND LEVEL OF EXPERIENCE NEEDED TO DESIGN DATA MANAGEMENT SYSTEMS FOR CLINICAL TRIALS AND EPIDEMIOLOGIC STUDIES OF VARYING DESIGN. SPECIFICALLY, THE RESEARCHERS PLAN TO CHOOSE SYSTEMS ANALYSIS SOFTWARE AND A DATA ENTRY PACKAGE AND USE THEM TO DESIGN A DATA MANAGEMENT SYSTEM FOR THE STUDY OF MENOGARIL (NSC 269148) IN A FUTURE PHASE II CLINICAL TRIAL OF PATIENTS WITH ADVANCED BREAST CANCER. THIS DEVELOPMENT PROJECT WILL SERVE AS A TEST BED FOR THE PROPOSED TOOL KIT. AT THE END OF THIS PHASE I CONTRACT, THEPROGRAM WILL DELIVER . A SYSTEMS DESIGN SPECIFICATION FOR THE MENOGARIL PROTOCOL . A DEVELOPMENT LOG DESCRIBING DAY- TO-DAY EXPERIENCE USING THE SOFTWARE . A QUESTIONNAIRE THAT STANDARDIZES THE SYSTEMS ANALYSIS FOR CLINICAL DATA MANAGEMENT SYSTEMS AND GUIDES PROFESSIONALS WHO ARE NOT FAMILIAR WITH DATA PROCESSING DETAILS OF SUCH SYSTEMS IN MAKING SUITABLE DESIGN CHANGES.