MS in Clinical Research Curriculum

Clinical Research Curriculum Topics

Weekly lecture/discussion series on Wednesdays from 5:00-6:30pm (2 year cycle beginning in Fall 2009)

Intro to Epidemiology Research (10 weeks)
Clinical Trial Design (10 weeks)
Health Services Research (8 weeks)
Clinical Research Design Workshop (12weeks)
Scientific Writing (8 weeks)
Biostatistics for Clinical Investigators (14 weeks)
Literature Appraisal (8 weeks)
Ethical Aspects of Clinical Research (8 weeks)
Introduction to Translational Research (6 weeks)
Clinical Research Design Workshop (12 weeks
Use of Computers in Clinical Research (online course, flexible schedule)

Advanced Courses for Master's Program

Required Advanced Courses (at Medical School)

Advanced Epidemiology (Wednesday afternoon, Spring 2008)

This course covers the analysis of complex observational studies with emphasis on the identification of interaction and control of confounding variables. Other topics include the use of matching, selection of appropriate control groups, and identification of potential sources of bias. A problem-based approach is used in which students are asked to solve design and analysis problems using existing data sets. Prerequisite: Intro to Epidemiology Research

Advanced Biostatistics for Clinical Investigators (Wednesday afternoon, Spring 2009)

This course will focus on the 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

Elective Advanced Courses for Master’s Program

Courses at the Medical School

Using Research to Inform Health Care Policy and Practice (Wednesday afternoon, Fall 2009)

In this course, the students apply rules of evidence and 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 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

Advanced Clinical Research Study Design (Wednesday afternoon, Fall 2010)

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. Either Advanced Epidemiology or Advanced Biostatistics is strongly recommended.

Courses at the School of Public Health

Methods for Economic Evaluation of Health Programs (Tues/Thurs morning, Fall semester)

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.

Courses at the Graduate School of Biomedical Sciences

Developmental Biology (Tues/Thurs morning, Fall semester)

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 (Tues/Thurs mid-day, Spring semester)

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 (Tues/Thurs mid-day, Fall semester)

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 (Tues/Thurs morning, Spring semester)

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 (Mon/Wed/Fri morning, Fall semester)

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

Additional Elective Courses

In addition to the above course requirements, 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 Health Information Sciences that meet their training goals.

Practica

Each student will be required to complete at least the first three of these practica:

Institutional Review Board
Scientific Presentation
Scientific Writing
Clinical Research Center

Thesis

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

Schedule for Program Completion

Completing the Program in a two-year period is possible but would require a considerable time commitment during each of the two years. Students with lesser time commitments to the Program could complete the curriculum in three, four, or more years. 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 will be given from 1:00-4:30 pm on Wednesdays before the Clinical Research Curriculum class so that students can complete the Master's Program by attending classes during one weekday each week. Students in the Translational Research Track are expected to have protected time during weekdays to attend classes at the Graduate School of Biomedical Sciences.

Sample Three-Year Completion Schedule
Patient-Based Clinical Research Track
Academic Year	Course Type	Fall	Spring	Summer
2009-2010	CRCA (Wed: 5:00-6:30)	Intro to Epi Research Clinical Trial Design	Clinical Trial Design (cont) Health Services Research Clinical Research Design Workshop	Scientific Writing
2009-2010	Other	Computers in Clinical Research
2010-2011	CRCA (Wed: 5:00-6:30)	Biostatistics for Clinical Investigators	Literature Appraisal Ethical Aspects of Clinical Research Introduction to Translational Research	Clinical Research Design Workshop
	Advanced (Wed: 1:00-4:30)	Advanced Clinical Research Study Design	Advanced Biostatistics
	Other	Thesis	Thesis	Thesis
2011-2012	Advanced (Wed: 1:00-4:30)	Using Research to Inform Health Care Policy and Practice	Advanced Epidemiology
2011-2012	Other	Practicum	Practicum	Practicum

MS in Clinical Research Curriculum

Clinical Research Curriculum Topics

Weekly lecture/discussion series on Wednesdays from 5:00-6:30pm (2 year cycle beginning in Fall 2009)

Intro to Epidemiology Research (10 weeks)

Clinical Trial Design (10 weeks)

Health Services Research (8 weeks)

Clinical Research Design Workshop (12weeks)

Scientific Writing (8 weeks)

Biostatistics for Clinical Investigators (14 weeks)

Literature Appraisal (8 weeks)

Ethical Aspects of Clinical Research (8 weeks)

Introduction to Translational Research (6 weeks)

Clinical Research Design Workshop (12 weeks

Use of Computers in Clinical Research (online course, flexible schedule)