BIOS 6314 - CLINICAL TRIALS METHODOLOGY

[3 Credits]

Three hours of lecture per week. Introduction to the conduct of clinical trials and clinical trials methodology. Topics covered include selection of primary and secondary research questions and hypotheses, use of surrogate variables, defining study population, generalizability of results, basic study design, randomization process, blinding, sample size estimation, using baseline assessments, recruitment of study participants, data collection and quality control, assessing and reporting adverse events, assessing quality of life, participant adherence, survival analysis techniques and issues, monitoring response variables, data analysis issues, study closeout, and reporting and interpreting results. Prerequisites: BIOS 6102 or BIOS 6202.