Data Management System for Clinical Research

To develop expertise in research design and statistical analyses appropriate to clinical research. The content of the program can be defined in a number of ways: the purposes of research, research design concepts, data collection methods, and statistical or analytical methods. The program provides concepts and methods that relate to the purposes of clinical research, clinical epidemiology, clinical trials, program evaluation, and technology assessment.

Research design concepts include the traditional approaches to the scientific method; the concepts of validity, reliability, causal relationships, role of randomization, standards for comparison, and sampling, as well as other recently developed methods of approaching decisions about research outcomes such as decision analysis and cost-utility analysis. The data collection methods deal with instrumentation, questionnaire construction, non reactive measures, survey techniques, qualitative data, measurement and standardization problems, concepts and criteria of normalcy, and disease and diagnostic criteria.

Statistical techniques for estimation and hypothesis testing, including comparison of proportions, chi-square test, comparison of means, analysis of variance and covariance, multiple regression analysis, logistic regression, and survival analysis are presented. In addition to a comprehensive curriculum in research design and statistical analysis, other content relevant to clinical researchers is included: ethical and legal issues in clinical research, technical writing skills and proposal/report writing, management of research, and behavioral factors in clinical research. Students learn computer skills and concepts, including data file management, data organization, and use of statistical packages. Visiting faculty with experience in specialized research subjects meet with the students to discuss current problems in clinical research.