Module Title:
Epidemiology and Clinical Research Methodology
Module Code:
DSB6333

Module Content

• Fundamentals of Epidemiology: What is epidemiology? History of Epidemiology, Emergence of modern epidemiology, Measures of Exposures, Types of exposures, Sources of exposures, Measures of outcome, disease registries, Classification of diseases.
• Clinical study Designs: Clinical research process and Health research ethics. Experimental and observational studies: Randomized and non-randomized studies. , Intervention studies, Cohort studies, case-control studies, cross-sectional studies, ecological studies, Measures of exposure effect, relative and absolute measures of effect, Confidence intervals and significance tests for measures of occurrence and effect.
• Design and conduct of clinical trials: the need and ethics of clinical trials, Drug Development Process, ICH GCP, Relevant FDA and EMEA guidelines (Industry, TA-, phase-specific), data management, objectives and end points of clinical trials, bias and random errors in clinical studies, conduct of clinical trials, overview of phase I-IV trials, multi-center trials. Design of clinical trials: parallel vs cross-over designs, cross-sectional vs: longitudinal designs. Design and analysis of Phase - I, Phase -II and Phase-III trials.