DATA ASSOCIATED WITH PRECLINICAL AND CLINICAL TRIALS THE PURPOSE OF PHASE I IS TO DEVELOP A PROTOTYPE, MICROCOMPUTER-BASED, DATA MANAGEMENT SYSTEM TO SUPPORT CLINICIANS CONDUCTING PRECLINICAL AND CLINICAL TRIALS OF POTENTIAL THERAPEUTIC AGENTS.

DATA ASSOCIATED WITH PRECLINICAL AND CLINICAL TRIALS THE PURPOSE OF PHASE I IS TO DEVELOP A PROTOTYPE, MICROCOMPUTER-BASED, DATA MANAGEMENT SYSTEM TO SUPPORT CLINICIANS CONDUCTING PRECLINICAL AND CLINICAL TRIALS OF POTENTIAL THERAPEUTIC AGENTS. EXPERIENCED COMPUTER PROFESSIONALS WILL WORK WITH GOVERNMENT PERSONNEL TO DETERMINE THE TYPES OF DATA REQUIRED FOR RAPID, CONCISE REVIEW OF THE PROGRESS OF CLINICAL AND PRECLINICAL STUDIES. TAILORED SOFTWARE SYSTEMS WOULD PROVIDE INVESTIGATORS WITH ONLINE DATA ENTRY AND RETRIEVAL IN COPY, GRAPHIC, OR STATISTICAL FORM. THE RESULTANT DATA BASED MANAGEMENT SYSTEM (DBMS) WOULD BE MENU DRIVEN FOR EASY ACCESS AND RAPID DAY ENTRY. SPECIFIC DATA FILES WILL ALLOW FOR DATA RETRIEVAL IN VARYING FORMATS WITHOUT DUPLICATE DATA ENTRY. MONTHLY PROGRESS REPORTS WOULD BE ENTERED EITHER DIRECTLY ONLINE OR AFTER RECEIPT BY THE PROJECT OFFICER. ALL ADMINISTRATIVE REPORTS COULD THEN BE EASILY GENERATED BY RECALLING SELECTED SUMMARIES AS REQUIRED. IF DESIRED, THE DBMS COULD BE INTEGRATED WITH A MAINFRAME FOR DIRECT AGENCY ACCESS OR MAINTAINED AND OPERATED ON A MICROCOMPUTER SYSTEM. THESE SOFTWARE PACKAGES WOULD CONFORM TO SPECIFIC DATA COLLECTION SETS DEVELOPED FOR ACTUAL PHASE II TRIALS. INCLUDED WOULD BE AN ADVANCED STATISTICAL PACKAGE WITH FLEXIBILITY TO COMPARE AND CORRELATE RESULTS FROM THE DIFFERENT STUDIES. THE SYSTEM WILL BE COMPATIBLE WITH UNIX AND PC-DOS OPERATING SYSTEMS.