Clinical Research Methods Masters Program

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.

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.

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.

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 provide an opportunity for active participation by the students in analyzing current translational literature and understanding the process by which therapeutic progress is made.

Use of statistical packages (6230: SAS; 6240: SPSS) and an introduction to mainframe computing with transmission of data.

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

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.

This is a second course in applied biostatistics. It covers one-way and two-way analysis of variance, repeated measures designs, simple and multiple regression and correlation analysis, analysis of covariance, and logistic regression.

This course presents selected concepts and methods from management practices that are useful in the public health setting. Topics concerning organizational structure, finance, budgeting, human resources, negotiation and others are presented with examples from public health practice.

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

Scholars will have a hands-on experience with the operations of a clinical research program. Scholars will work with a Tulane faculty and their clinical research group as a trainee member. During the 8 week tenure, the Scholar will evaluate clinical research opportunities, analyze protocol appropriateness vis a vis patient population, analyze resource and personnel needs, budget, and implementation strategies. Scholars will work alongside clinical research staff to evaluate eligibility, provide informed consent, and gather and manage data. Scholars will also work with regulatory personnel to process protocols for IRB and to monitor the protocol progress and process adverse event reports relative to the research study. Prerequisite will be CITI Certification.