Clinical Research Curriculum
Weekly lecture/discussion series on Wednesdays from 5:00-6:30pm (2 year cycle beginning in Fall 2017)
*Current or anticipated Master’s students are required to participate in the Honors component of these courses.
- Introduction to Epidemiology Research* (11 weeks)
- Clinical Trial Design* (11 weeks)
- Clinical Research Design Workshop (12 weeks)
- Social and Behavioral Aspects of Clinical Research (8 weeks)
- Healthcare Quality and Safety (8 weeks)
- Biostatistics for Clinical Investigators (11 weeks)
- Literature Appraisal (9 weeks)
- Ethical Aspects of Clinical Research (8 weeks)
- Introduction to Translational Research (7 weeks)
- Clinical Research Design Workshop (12 weeks)
- Translational Research Design Workshop (12 weeks)
- Use of Computers in Clinical Research (online course, flexible schedule)
Advanced Courses for Master’s Program (at McGovern Medical School)
Using Research to Inform Health Care Policy and Practice (required, Fall 2017)
In this course, the students apply rules of evidence and of prinicples of health services research to clinical practice, practice guidelines, and health care policy. Decision analysis and methods for quantifying benefit, risk, and cost will be used to evaluate health care interventions at the individual patient, group practice, and population levels. This critical appraisal will be used to launch discussions of mechanisms to bridge the gap between clinical research evidence and health services delivery and health policy. Prerequisite: Literature Appraisal.
Methods of Economic Evaluation in Clinical Research (Spring 2018)
This course will provide in depth exposure to the different economic evaluation methods used to assess the value of health care interventions and programs. Participants will learn how to critique and interpret economic evaluation studies and apply it in their own research projects. The course will also provide an introduction to research involving research networks, registry and administrative data with a hands-on introduction to publicly available datasets that the students will have the opportunity to use in preparation for their required research proposal. A working knowledge of the principles of epidemiology, literature appraisal, and study design is required.
Advanced Clinical Research Study Design (Fall 2018)
This course will build on design concepts for observational and interventional studies that were introduced in the Clinical Research Curriculum courses. Topics will include the use of matching and restriction to minimize bias in observational studies, consideration of analytic strategies (eg correlated samples, use of propensity scores) in study design, survey research methods, the relationship between quality improvement and clinical research, adaptive randomization, alternatives for consent for research, factorial designs, cluster randomization, using patient values to select important study outcomes, weighing benefits and harms, approaches to stopping rules, and enhancing feasibility of clinical trials. Prerequisites: Introduction to Epidemiology Research and Clinical Trial Design. Advanced Biostatistics is strongly recommended.
Advanced Biostatistics for Clinical Investigators (required, Spring 2019)
This course will focus on the principles and mechanics of applying biostatistical techniques in a research setting. Emphasis will be placed on assumption testing and techniques of model fitting. Students will be expected to critically evaluate, develop, and execute analysis plans using descriptive analysis and regression techniques. Prerequisite: Biostatistics for Clinical Investigators
Additional Elective Courses
In addition to the above coursework, students are encouraged to take any other courses offered at the Medical School, School of Public Health, Graduate School of Biomedical Sciences, or School of Biomedical Informatics Sciences that meet their training goals. Some examples are listed below, but students are not limited to these options. Outside coursework must be approved by the student’s program advisor prior to enrollment.
Methods for Economic Evaluation of Health Programs (School of Public Health)
This course introduces the concepts and methods for the economic analysis of health care decision alternatives. Topics will include cost-benefit, cost-effectiveness and cost-utility analyses, and other methods of decision analysis. It emphasizes the application of these methods to the evaluation of alternative health care programs.
Economic and Social Determinants of Health (School of Public Health)
This course introduces the concept of health of populations and studies the reasons for health disparities between countries and between socioeconomic and racial/ethnic groups within countries. It takes an approach to health that identifies the social factors that influence the health of populations. The course objectives are to explore the social, cultural, and economic factors that influence the health of populations, identify systemic variations and examine how they are reflected in health disparities among population groups.
Developmental Biology (Graduate School of Biomedical Sciences)
The mechanisms of embryogenesis and cellular differentiation will be discussed in terms of experimental evidence. The course will emphasize molecular, cellular, and genetic analysis of developmental systems. Assigned reading will be recent research articles related to each lecture. These reading assignments, class lectures, and suggested readings in a standard textbook should give the student the opportunity to understand the major research problems in developmental biology and the methods used to solve these problems.
Molecular and Cellular Approaches to Human Genetics (Graduate School of Biomedical Sciences)
This course introduces the student to human biochemical, molecular and somatic cell genetics, relating them to classical and newer cytogenetics approaches. Discussions will emphasize the molecular characterization of genotype and its relation to the human phenotype in health and disease.
Genetics and Human Disease (Graduate School of Biomedical Sciences)
This course introduces principles and methods of human genetic analysis with special reference to the contribution of genes to our burden of disease. Although molecular, biochemical and morphogenic processes controlled by genes will be briefly surveyed; the aim is to describe the analytical processes whereby genetic mechanisms are inferred and genes located on chromosomes.
Eukaryotic Gene Expression (Graduate School of Biomedical Sciences)
This is an advanced molecular genetics course in which current results and theories, based on primary journal articles, will be discussed. The primary emphasis will be on the transcriptional regulation of gene expression. The effect of chromatin conformation, RNA splicing and 3′ sequences on gene expression will also be discussed.
Cancer Biology (Graduate School of Biomedical Sciences)
This is a lecture course on aspects of recent progress and active research in cancer biology. Topics will include tumor/host interactions, metastasis and invasion, tumor cell biochemistry, tumor heterogeneity, therapy, cell surfaces, and development aspects
Each student will be required to complete one or more thesis project(s) that collectively demonstrate competence in each of these areas:
To critically review clinical research literature
To postulate a sound new research question and design a clinical research study to address this question using the most unbiased feasible design
To properly analyze and interpret clinical research findings
Each student will be required to complete all three of these practica:
Institutional Review Board
Schedule for Program Completion
Courses in the Clinical Research Curriculum are given from 5:00-6:30 pm on Wednesday evenings to accommodate students with clinical responsibilities during the day. The advanced courses for the Master’s Program are given from 1:00-4:30 pm on Wednesday afternoons so that students can complete the Master’s Program by attending classes during one weekday each week.
Applicants are strongly encouraged to apply after completing at least one year of CRC coursework. Masters students are required to complete at least one thesis component per year after admission. Students must complete all degree requirements within 5 years after admission, and must complete at least one degree requirement (course, practicum, thesis) per year. A minimum of 20% protected time is required to complete the Program. Students in the Translational Research Track are expected to have protected time during weekdays to attend classes at the Graduate School of Biomedical Sciences.
For more information regarding the program, please email Deborah Garcia, MS Program Coordinator or call our office at (713) 500-6708.