The Capstone in Fundamentals of Clinical Research consists of five courses for a total of 13 semester credits. We assume that, depending on the clinical and research load of the resident or medical fellow, they may complete the course-work requirements in 1-2 years at the most.
Required Courses
Biostatistics and Medical Informatics 541 (3 credits) - Introduction to Biostatistics - is designed for the biomedical researcher. Topics include: descriptive statistics, hypothesis testing, estimation, confidence intervals, t-tests, chi-squared tests, analysis of variance, linear regression, correlation, nonparametric tests, survival analysis and odds ratio. Biomedical applications are discussed for each topic.
Biostatistics and Medical Informatics 542 Introduction to Clinical Trials l 3 credits. Intended for biomedical researchers interested in the design and analysis of clinical trials. Topics include definition of hypotheses, measures of effectivenesalths, sample size, randomization, data collection and monitoring, and issues in statistical analysis. Statistics graduate students should take Stat 641. Prerequisite: Stat 541 or equivalent or instructor's consent
Biostatistics and Medical Informatics 544 Introduction to Clinical Trials ll- This course will provide practical experience and training in clinical trial research. The course will focus on the design, implementation, and conduct of clinical trials. Topics include: regulatory requirements for cinical trials; data collection strategies, data quality and management; budget development and justification; federal, institutional, and sponsor-defined requirements; establishment of research infrastructures for safety and success; preparation of investigator-INDs; investigator responsibilities in Phase l-IV trials. Development of data collection and data management systems and a budget for the protocol developed in 541 are require components of this course.
Biostatistics and Medical Informatics 546 (3 credits) - Practicum in Clinical Trial Data Analysis and Interpretation - Practicum in the analysis and interpretation of data from national and international clinical trials in a variety of diseases available in the Department. This has a potential to lead to NIH R03, Small Analysis Grant, applications based on generations of new hypotheses from the existing large scale clinical trial data. This Practicum will serve as the "Capstone" Experience for individuals enrolled in the program.
History of Medicine 545 (1 credit) - Ethical and regulatory issues in the design, conduct and reporting of research will be examined. Topics include history, consent, randomized clinical trials, special subjects, medical records and database research, cultural issues, research in developing countries, animal studies and institutional review boards and responsible conduct of research.
Pop Hlth 797 - Introduction to Epidemiology. Fall; 3 credits. Lectures and discussions on design, implementation and interpretation of epidemiologic studies; emphasis on methodologic problems in the measurement of disease frequency, natural history and risk factors. Prerequisites: Grad st in clinical/life science or cons inst. Trentham-Dietz.
