Coursework

Coursework

The Program offers six core courses on Pharmacoepidemiology, Introduction to Pharmacoepidemiology, Advanced Pharmacoepidemiology, Seminars in Drug Safety and CER, Health Services Research, and Propensity Scores.

Pharmacoepidemiology (EPI221, Fall). Instructor: Dr. Alexander Walker. Within the framework of formal epidemiologic analysis, this course covers inference about the effects of pharmaceuticals from case reports, case series, vital statistics and other registration schemes, cohort studies, and case-control studies. Decision-making with inadequate data is examined from the perspectives of manufacturers and of regulators. Students are graded on the basis of group projects. This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry or in national regulatory bodies, but may have more general interest as an applied mid-level course with a heavy methodological emphasis.

Advanced Pharmacoepidemiology (EPI286, Spring). Instructors: Dr. Sebastian Schneeweiss and guest lecturers. Using current examples and with the participation of active researchers in pharmacoepidemiology, this course addresses a range of study designs and analytic techniques for observational studies on the utilization, safety, and effectiveness of pharmaceuticals. Students will develop an understanding of how to plan, implement, analyze, and criticize pharmacoepidemiologic studies. Original research will be presented by principal investigators, followed by intensive discussions on design options, analytic strategies, and sensitivity analyses of confounding and misclassification bias. Lectures will provide methodological background and will cover applied issues typically encountered in pharmacoepidemiology. This course is intended primarily for graduate students considering a career in the pharmaceutical/biotech industry, pharmaceutical benefits management, or in national regulatory bodies.

Health Services Research Epidemiology (EPI235, Spring) Instructors: Dr. Soko Setoguchi and guest lecturers. This course is designed to introduce students to the application of standard epidemiologic methods to Health Services and Outcome Research. The course helps students to recognize how the principles of Epidemiology apply to Health Services and Outcome Research, and understand the terminology and methods specific to the field. Threats to validity including selection bias, confounding, information bias, and methods for their control will be discussed in a variety of settings emphasizing practical considerations. Lectures include recent or ongoing case studies and examples from the literature. Topics include quality of care assessment, health service use assessment, cost assessment, health outcome assessment, risk-adjustment, comparative effectiveness research, and program evaluation.

Case-based Seminars on CER and Drug Safety (EPI298, Spring) Instructors: Drs. Sonia Hernandez-Diaz and Soko Setoguchi. This course acquaints students with practical issues in CER and drug safety research. Through the critical review and thoughtful discussion of crucial drug safety debacles, the students will develop an understanding of which adverse drugs effect have shaped our discipline, how were they discovered, with what delay, which were the specific methodological challenges, what were the political implications and, most importantly, which lessons have we learnt. Recent examples on comparative effectiveness and safety discussion in the scientific literature or at FDA advisory committees will be recreated in class. Students are graded on the basis of participation in class discussion and preparation of a group project. This course is intended for students whose career might involve the development, prescription, marketing, evaluation or regulation of drugs.

Propensity Score Analysis: Theoretical & Practical Considerations (EPI 271, Winter) Instructor: Dr. John Seeger. This course introduces basic and advanced theory underlying propensity score analyses and provides practical insights into the conduct of studies employing the method. Course readings will include propensity score theory as well as applications. Lectures are complemented by computer lab sessions devoted to the mechanics of estimating and using the propensity score as a tool to control for confounding in observational research. Students should have knowledge in multivariable modeling approaches. A course project will involve the application of propensity scores to a data set.

Introduction to Pharmacoepidemiology (EPI295, Summer). Instructor: Dr. Arnold Chan. This is an introductory course on pharmacoepidemiology. How the principles of modern epidemiology methods are used to evaluate the safety, effectiveness, and utilization patterns of drugs, vaccines, and medical devices will be discussed. Examples of descriptive epidemiology studies, cohort studies, case control studies, and intervention studies will be drawn from recent literature to illustrate the application of relevant methods and the challenges in drug safety assessment. Drug safety assessment from the pharmaceutical and biotechnology industry perspective and the regulatory perspective will be discussed. Practical issues such as data sources, ethical principles and advanced methodologic topics, such as confounding by indication and misclassification and the analytic methods to address them will be briefly introduced.

Program Courses

The Program offers six core courses on Pharmacoepidemiology, Introduction to Pharmacoepidemiology, Advanced Pharmacoepidemiology, Seminars in Drug Safety and CER, Health Services Research, and Propensity Scores.

Pharmacoepidemiology (EPI221, Fall). Instructor: Dr. Alexander Walker. Within the framework of formal epidemiologic analysis, this course covers inference about the effects of pharmaceuticals from case reports, case series, vital statistics and other registration schemes, cohort studies, and case-control studies. Decision-making with inadequate data is examined from the perspectives of manufacturers and of regulators. Students are graded on the basis of group projects. This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry or in national regulatory bodies, but may have more general interest as an applied mid-level course with a heavy methodological emphasis.

Advanced Pharmacoepidemiology (EPI286, Spring). Instructors: Dr. Sebastian Schneeweiss and guest lecturers. Using current examples and with the participation of active researchers in pharmacoepidemiology, this course addresses a range of study designs and analytic techniques for observational studies on the utilization, safety, and effectiveness of pharmaceuticals. Students will develop an understanding of how to plan, implement, analyze, and criticize pharmacoepidemiologic studies. Original research will be presented by principal investigators, followed by intensive discussions on design options, analytic strategies, and sensitivity analyses of confounding and misclassification bias. Lectures will provide methodological background and will cover applied issues typically encountered in pharmacoepidemiology. This course is intended primarily for graduate students considering a career in the pharmaceutical/biotech industry, pharmaceutical benefits management, or in national regulatory bodies.

Health Services Research Epidemiology (EPI235, Spring) Instructors: Dr. Soko Setoguchi and guest lecturers. This course is designed to introduce students to the application of standard epidemiologic methods to Health Services and Outcome Research. The course helps students to recognize how the principles of Epidemiology apply to Health Services and Outcome Research, and understand the terminology and methods specific to the field. Threats to validity including selection bias, confounding, information bias, and methods for their control will be discussed in a variety of settings emphasizing practical considerations. Lectures include recent or ongoing case studies and examples from the literature. Topics include quality of care assessment, health service use assessment, cost assessment, health outcome assessment, risk-adjustment, comparative effectiveness research, and program evaluation.

Case-based Seminars on CER and Drug Safety (EPI298, Spring) Instructors: Drs. Sonia Hernandez-Diaz and Soko Setoguchi. This course acquaints students with practical issues in CER and drug safety research. Through the critical review and thoughtful discussion of crucial drug safety debacles, the students will develop an understanding of which adverse drugs effect have shaped our discipline, how were they discovered, with what delay, which were the specific methodological challenges, what were the political implications and, most importantly, which lessons have we learnt. Recent examples on comparative effectiveness and safety discussion in the scientific literature or at FDA advisory committees will be recreated in class. Students are graded on the basis of participation in class discussion and preparation of a group project. This course is intended for students whose career might involve the development, prescription, marketing, evaluation or regulation of drugs.

Propensity Score Analysis: Theoretical & Practical Considerations (EPI 271, Winter) Instructor: Dr. John Seeger. This course introduces basic and advanced theory underlying propensity score analyses and provides practical insights into the conduct of studies employing the method. Course readings will include propensity score theory as well as applications. Lectures are complemented by computer lab sessions devoted to the mechanics of estimating and using the propensity score as a tool to control for confounding in observational research. Students should have knowledge in multivariable modeling approaches. A course project will involve the application of propensity scores to a data set.

Introduction to Pharmacoepidemiology (EPI295, Summer). Instructor: Dr. Arnold Chan. This is an introductory course on pharmacoepidemiology. How the principles of modern epidemiology methods are used to evaluate the safety, effectiveness, and utilization patterns of drugs, vaccines, and medical devices will be discussed. Examples of descriptive epidemiology studies, cohort studies, case control studies, and intervention studies will be drawn from recent literature to illustrate the application of relevant methods and the challenges in drug safety assessment. Drug safety assessment from the pharmaceutical and biotechnology industry perspective and the regulatory perspective will be discussed. Practical issues such as data sources, ethical principles and advanced methodologic topics, such as confounding by indication and misclassification and the analytic methods to address them will be briefly introduced.