TRAINING MODULES FOR CLINICAL EPIDEMIOLOGICAL RESEARCH

WE WILL DEMONSTRATE THE VALUE AND PRACTICALITY OF DEVELOPING A TWO VOLUME TEXTBOOK/TRAINING MANUAL FOR: A) THE DESIGN, CONDUCT AND ANALYSIS OF CLINICAL TRIALS; AND B) THE DESIGN, CONDUCT AND ANALYSIS OF CASE-CONTROL STUDIES. TO THIS END, MODULES WILL BE DEVELOPED WHICH INTEGRATE TEXT, STATISTICAL SOFTWARE AND ILLUSTRATIVE DATASETS TO PROVIDE A PACKAGE FOR SELF-INSTRUCTION OR USE IN A TRAINING COURSE. SOFTWARE WILLBE BASES ON EXISTING COMMERCIAL SOFTWARE PACKAGES, EPILOG PLUS AND POWER, DEVELOPED BY A CONSULTANT TO THIS PROJECT. DATASESTS WILL BE DERIVED FROM NIH-FUNDED CLINICAL TRIALS AND CASE-CONTROL STUDIES TO ILLUSTRATE THE PROCEDURES BEING TAUGHT. IN PHASE I, SIX MODULES WILL BE WRITTEN AND PROGRAMMED: CLINICAL TRIALS (DESIGN OF PHASE II STUDIES, INTERIM REPORTS FOR PHASE III STUDIES, AND STRATEGIES FOR ENDPOINT ANALYSES FOR PHASE III STUDIES); AND CASE-CONTROL STUDIES (CASE SELECTION, CONTROL SELECTION, AND RELATIVE RISK ESTIMATION).