Clinical Research Masters Program ~ Curriculum

Introduction to statistical methodology in the health field. Topics covered include presentation of data (graphs and tables), descriptive statistics, concepts of probability, estimation of parameters, hypothesis testing, simple linear regression, correlation, and the analysis of attribute data. The course is recommended for students needing a firm foundation in statistical methods either for their careers or for preparation for further quantitative courses.

The purpose of this course is to prepare students to function effectively as mid-level epidemiologists in public health agencies or other settings. The knowledge base and skills that are the focus of this course are fundamental to the scope of work expected of master's degree graduates in epidemiology. The course focuses on epidemiologic approaches to activities that are a routine part of public health practice.

This course will cover basic principles of bioethics and their specific application to clinical research. Special attention will be paid to the ethical obligation of the researcher to the participant within the broader framework of patient care and the ethics of caring. Specific challenges of vulnerable populations and research in a global community will also be considered. This course will also cover differences between clinical research and clinical practice, responsibilities regarding data records, data ownership, collaborative and multi-site issues and authorship. Substantive information will be provided about how to conduct clinical research in an ethical manner, especially in the complex and competitive research environment. This course will define research misconduct, falsification and fabrication, with numerous examples to assist in areas that may not be regulatory. Conflict of interest issues present some of the most complex and potentially volatile challenges in the area of clinical research, they will be covered as well.

In this course, students will study IRB relations and regulations, discuss the required elements in a clinical research contract and the responsibilities of the clinical researcher, identify effective use of research personnel, and develop negotiating skills to facilitate support for clinical research. The course will also encompass the principle of randomization and "intention-to-treat" analysis in experimental studies, integration of clinical trials and lab support, specimen collections and laboratory problem based learning. A researcher/clinician centric insight into the logistics of technology transfer and intellectual property (IP) development will be studied. The practical aspects of technology transfer in an academic context will be investigated. Discussed topics will include local academic tech transfer policy, related procedures and available resources. Career pathways and opportunities open to the clinical researcher in the academic and private sector will be explored and discussed.

Core course discussing the elements of effective research design, including the basic concepts in clinical trials, the main aspects for different types of trials such as proof of principle stage, Phase I, II, III and IV, and understanding good clinical research methodology. Course will introduce and address issues, idea and outline of design methodology that cover planning, conducting, analyzing, and assessing clinical trials. Concepts and principles of study finance, costing and budgeting will be discussed.

Clinical and translational research in the medical school setting will have a heavy focus on discovery, development, and application of "targeted therapy". The Molecular Medicine Course will review the molecular pathophysiology of diseases that have broad implications on health. For instance, obesity and metabolic syndromes will be addressed as molecular risk factors for cardiovascular disease, cancer, diabetes, and neurodegenerative diseases; molecular pathways of inflammation will be addressed as risk factors for cancer, atherosclerosis, arthritis, and gastrointestinal disorders. Potential molecular targets for drug development and the experimental sequence from discovery to clinical trial will be emphasized.

This is an interactive course designed to:

1. Introduce general concepts of health disparities, social determinants of health, and cultural competence;
2. Apply concepts to real case scenarios through classroom discussions & in the field assignments

This course is taught as a tutorial, specifically designed to meet the needs of each scholar when they are ready to write their career development (K) grant.  They learn to identify funding and to strategize the best Institute and K mechanism for their research.  They receive extensive help in writing their Career Development section as well as having access to samples of funded K awards.

Monthly conference at which students will present and discuss clinical research proposals and published literature.

Each Clinical Research Scholar will identify a research preceptor from the scholar's home division or department. In addition, each scholar will have a career mentor from the MSCR program.