Pharmacoepidmiology.   25 contact hours over four days.  Outside preparation 10 hours.   Up to 40 Students.

Advanced Topics in Pharmacoepidemiology.  12 hours over either two or four days.  Selected topics.  Outside preparation five hours.

Topics:
•    Risk assessment under uncertainty
•    Design, analysis and interpretation

o    Case reports, case series
o    Clinical trials
o    Cohort studies
o    Case-control studies
o    Case-crossover studies

•    Large databases from administrative and electronic medical records

o    Proactive assessment of automated data
o    Rapid cycle analysis
o    Pooling and collaborative analysis

•    Advanced techniques

o    Propensity
o    Proxies
o    Instrumental variables
o    Comorbidity Scores
o    Genetics
o    Data mining
o    Capture-recapture

Format.  Classes include lectures, discussions and workshop-style review of examples and illustrative papers.  The workshops are highly interactive, and require outside preparation.  Faculty have experience in eliciting participation in a way that highlights positive contributions and builds a group consideration of difficult questions.

Student Comments on Advanced Topics in Pharmacoepidemiology July 17-18, 2008

"Enjoyed it, very helpful." 
"Great course.  I'm much more at ease with propensity scores.  Looking forward to future courses."
"Excellent, thank you."

Available through the International Epidemiology Summer School
Muenster, Germany, co-directed by Dr. Tobias Kurth

Introduction to Principals and Methods of Epidemiology
Five 4-hour lectures

The objective of this course is to develop the participants' ability to critically evaluate the quality of published medical literature. This will be accomplished by acquainting the participants with the basic principles and methods of the design, conduct and interpretation of epidemiologic studies. Particular emphasis will be placed on the various epidemiologic strategies, such as descriptive studies (case-reports and case series, ecologic studies and cross-sectional surveys), observational analytic studies (case-control and cohort) and randomized clinical trials. In addition, the course will include basic biostatistical techniques for the presentation and analysis of data and the understanding of statistical association as well as cause and effect relationships. Actual examples will be provided from the published medical literature.

An Introduction to Propensity Score Analyses
Four hours lecture

The objective of this course is to introduce propensity score analyses based on clinical examples and theoretical considerations. Particular emphasis will be placed on how to construct a propensity score model and on how to utilize the propensity score to adjust for confounding. Whether the propensity score differs compared to other methods in confounding control will also be discussed. Participants will receive theoretical and practical examples of propensity score analyses from the literature. This course is particularly recommended for individuals with interest in pharmacoepidemiology and the evaluation of drug safety studies. Upon completion of the course, participants will have an overview of what propensity score methods can and cannot accomplish.


Available through the Harvard School of Public Health

Pharmacoepidemiology
Epi221
Fall 2
Dr. A. Walker
Lectures. Four 2.5-hour sessions each week.

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.
Course Activities: Written and oral group projects, individual class presentations, class discussion.


Study Design in Epidemiologic Research
Epi203
Spring 2
Dr. A. Walker
Lectures. Two 2-hour sessions each week.

Beginning with the randomized clinical trial as a paradigm, this course examines common problems in the design, analysis, and interpretation of observational studies. Cohort and case-control studies are the focus of the discussion, but not to the exclusion of other designs. Problems of exposure and disease definitions, time-dependent effects, confounding, and misclassification are considered in the light of data sources typically available. Relevant statistical methods are introduced but not developed in detail.
Course Activities: Review of published studies, class discussion.

Propensity Score Analysis: Theoretical & Practical Considerations
Epi 271
Winter
Drs. T. Kurth and J. Seeger
Five 2-hour lectures and four 2-hour computer lab sessions

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.