Year 1 Courses

Each course is given over one 10-week quarter.

Epidemiology I: Happy Araneta, 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

 

 

Epidemiology II: Happy Araneta, 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 written exam.

Course Content: 

Topic

Content

Epidemiology I Review

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.

 

 

Patient Oriented Research 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

Content

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
 

Patient Oriented Research II: Allen McCutchan, M.D., M.Sc.

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

Content

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