Principles of Clinical Research.
General principles and issues in clinical research design. Formulating the research objective and the research hypothesis; specifying the study population, the experimental unit and the response variable(s). Classification of studies as experimental or observational, prospective or retrospective, case-control, cross-sectional, or cohort their relative advantages and limitations and the statistical methods used in their analysis. Emphasis is placed on the traditional topics of clinical epidemiology such as disease etiology, causation, natural history, diagnostic testing, and the evaluation of treatment efficacy.
This course extends the concepts developed in Introduction to Statistical Methods to more advanced topics relevant in clinical research. Topics include regression models (linear and logistic regression models), their practical applications in assessing multivariable relationships and formulating predictive models, and the interpretation of model parameters); categorical data analysis (methods for analyzing nominal and ordinal response variables); and survival analysis (inferences from time-to-event data with censored observations, including Kaplan-Meier curves, hazard functions and the Cox proportional hazards regression model).
An introduction to the critical issues and methods in the management of clinical research. The focus is on the understanding of concepts and skills related to the complex, multidisciplinary environment in which clinical research is conducted. Topics include budget construction and financial management, project management, regulatory affairs, negotiating skills, conflict resolution, manuscript preparation, public relations, presentation skills, and alternative means of disseminating medical information.
Clinical Research Seminar.
This seminar integrates and builds on the core courses to provide practical experience in the development and critique of the methodological aspects of clinical research protocols and the clinical research literature. Assigned readings are drawn from contemporary literature and include both exemplary and flawed studies.