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Year 1 Courses
Each course is given over one 10-week quarter.
Epidemiology I: Deborah Wingard, Ph.D.
Objectives: Scholars will recognize and understand different types of epidemiologic study designs, the relative strengths and limitations of each, and the proper choice of study design in conducting their own research. They will also be able to identify and calculate the correct measure of risk for each study design. Participants will recognize major sources of bias, confounding, interaction and misclassification, and understand design and analysis methods of dealing with each. They will also be familiar with criteria to differentiate association from causation, and understand the components of causality. Participants will conclude this course with a written final examination.
Course Content:
Topic |
Content |
Introduction |
Disease transmission, population based investigation |
Epidemiological Measurement |
Rates, adjusted rates, prevalence, incidence |
Cross-Sectional Studies |
Design, implementation and analysis |
Prospective/Cohort Studies |
Design, implementation and analysis |
Case Control Studies |
Design, implementation and analysis |
Intervention Studies/Experimental |
Design, implementation and analysis |
Bias, Confounding and Interaction |
How to recognize, avoid, or correct |
Screening and Diagnostic Testing |
Sensitivity, specificity, screening programs |
Causality |
Association vs. Causality, components of causality |
Review for Final Exam |
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Epidemiology II: Deborah Wingard, Ph.D.
Objective: Scholars will build on the content of Epidemiology I by attending guest lectures given by epidemiologists currently active in their field. Both methodology and content will be addressed in these guest lectures including topics such as smoking studies, genetic epidemiology, reproductive epidemiology, ecological studies, and the epidemiology of violence. Students will also gain an understanding of health disparities in epidemiologic research and be exposed to additional and advanced epidemiologic methods such as meta-analysis and cluster analysis. Participants will become familiar with advanced epidemiological issues and understand how study designs are practically applied in specific content areas. Students conclude this course with a comprehensive written research proposal that could be submitted for funding.
Course Content:
Topic
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Content
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Epidemiology I Review
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Review basic epidemiologic concepts |
Smoking Studies |
Study design, outcomes, controversies |
Ecological Studies |
Current topics and examples of this study design |
Health Disparities |
How health disparities are defined and measured in epidemiologic studies |
Epidemiology of Violence |
How epidemiology is applied to the study of violence and public health |
Reproductive Epidemiology |
Current studies in reproductive epidemiology |
Genetic Epidemiology I |
Basic concepts |
Genetic Epidemiology II |
Advanced concepts |
Advanced Methods |
Meta-analysis, cluster analysis or others |
Final Proposal Review |
Final proposals are reviewed by faculty and peers. |
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Patient Oriented Research I (POR-I): Allen McCutchan, M.D., M.Sc.
Objectives : This course will develop and apply the theory of clinical trial design and analysis, discuss the practical issues of financing and implementation of clinical trials, and describe issues of monitoring trials and working in cooperative groups. The scholar will design and present to a group of peers a concept sheet for a
phase I/II and phase II/III clinical trial.
Course Content:
Topic
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Content
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Hypothesis Generation and Formulation |
Framework, Types, and Characteristics of Good Research Questions and formulating a testable hypothesis |
Introduction to POR |
Definition of POR; Origins & Scientific Basis; Causality; Validity of Inference; Classification of Clinical Research |
| Measurement |
Objectives, classes, and characteristics of measures in POR and their validity, accuracy, and precision |
Fundamentals of Clinical Trials |
Study Objectives, Target Populations, Comparison Groups, Blinds, Outcomes and Endpoints |
Overview of the Process of Drug and Device Development |
Preclinical and clinical development of drugs from an industrial prospective |
Statistical Issues in Clinical Trials |
Sample Size/ Power Analysis; Randomization Procedures; Analytic Strategies - Sequential, Interval and Terminal; Analysis Plan |
Selecting and Measuring Outcomes and Study Implementation I |
Outcomes: Selecting outcomes: who gets counted, clinical vs surrogates, and simple vs compound. Implementation: Defining, recruiting, consenting, initially assessing, tracking, and retaining participants; IRB submission. |
| Study Implementation II |
Assessing Adherence; Study Start-up Study Monitoring for adverse events and interacting with the IRB; Completing the study, DSMB review |
| Complex Trial Design |
Multi-centered studies, Crossover and Factorial Designs, equivalence vs superiority trials, and testing diagnostics |
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Patient Oriented Research II: Allen McCutchan, M.D.
Objectives: This course will review the ethics and basic regulatory issues for research involving human subjects; the principles of data management for clinical research, including architecture, access and confidentiality, and integrity of databases; and skills in graphic and verbal presentation of research data. Scholars will prepare a mock submission to the IRB for peer review and practice presenting graphic and tabular data.
Course Content:
Topic
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Content
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Foundations of Research Regulation
Introduction to the IRB: |
Overview of the regulation of human experimentation; Structure and Function of IRBs |
Writing and reviewing an IRB Proposal
(monitoring boards) |
Principles of IRB review
Preparation and review of applications to the IRB |
| Monitoring of Research |
Composition and functions of Data and Safety Monitoring Boards (DSMB) |
| Ethical Basis of protection of research subjects |
Ethical principles for protection of human research subjects |
| Research Ethics - Responsible conduct |
Conflict of interest and commitment, scientific integrity, misconduct, ethics of publishing |
| Business ethics, research budgeting, and contracts |
Preparing and managing a research budget |
| Selected topics in the ethics of patient oriented research |
Discussion by students of their personal case studies in ethics |
Peer Critique of Student IRB submissions I
(Simulated IRB review panel) |
Discussion of student IRB proposals by peer reviewers |
| Legal Aspects of informed Consent |
Introduction to legal issues related to informed consent |
| Peer Critique of Student IRB submissions II (Simulated IRB review panel) |
Discussion of student IRB proposals by peer reviewers |
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Professional Development I: Gerry Boss, M.D.
Objectives : Scholars will learn the fundamentals of clear scientific writing and oral presentation of scientific work. They will also learn how to write an NIH-style grant including all components of a grant.
Course Content
Topic |
Content |
Overview |
General principles of scientific writing and oral presentation |
Scientific Writing |
Specific examples of good and bad writing; in-depth discussion of all parts of a scientific paper; scholars will be expected to write an abstract which will be reviewed in class. |
Presentation Skills |
Instruction in how to give oral presentations and how to prepare posters; scholars will give a 10-15 minute presentation to the class. |
Grant writing -A |
Scholars will learn how to write a KO8 or K23 type NIH grant with detailed instruction in all parts of a grant. Scholars will write a grant which will be reviewed by the instructor. |
Grant writing -B |
Scholars will review a grant and will participate in a mock study section led by a faculty member. |
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Question/suggestion, email the webmaster: Seble Chernet
Last updated:
November 4, 2009
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