Course Aim

Pharmacoepidemiology requires the utilization of database resources to evaluate drug safety. This course will define the different types of data resources available for pharmacoepidemiology and the selection criteria to select the most appropriate resource. The course focuses on the Guidelines for good database selection and use in pharmacoepidemiology research, provides an overview of available resources, addresses the need for outcome validation, and highlights data linkage considerations.

Requisites Statement: Intermediate level course. The course assumes attendees have either taken entry-level pharmacoepidemiology courses at ISPE or through didactic coursework.

Course Objectives

1. To review the Guidelines for Good Database Selection and use in Pharmacoepidemiology Research.
2. To gain an understanding of available pharmacoepidemiology resources
3. To develop the skills to select an appropriate resource to conduct pharmacoepidemiology research
4. To examine validation methods for assessing the quality of pharmacoepidemiology data sources
5. To provide an overview of data linkage of available pharmacoepidemiology resources particularly to patient registry data resources

 Syllabus Outline

Overview of Database use in Pharmacoepidemiology: The presentation will review the ISPE Guidelines for good database selection and use in pharmacoepidemiology research. The focus will be on the application of the guidelines in a topically updated portfolio of pharmacoepidemiology studies.

Selection of Databases for Pharmacoepidemiology Research: The presentation will review available resources updated to reflect the dynamic changes to the availability of resources across an international landscape.

Database Approaches to Patient Follow-Up for Clinical Trials: Facilitated discussion of the capabilities of pharmacoepidemiology databases to collect data for clinical trial investigations for Real-World Evidence generation from pragmatic clinical trials.

Database Selection Workshop Activity: An interactive coffee break in which participants will be exposed to several pharmacoepidemiology-specific aims and asked to provide potential database resources to address the research questions.

Data validation approaches in pharmacoepidemiology: An overview of the various approaches available to conduct validation studies. The presentation will focus on the mechanics of medical record validation studies and the impact on bias analyses within pharmacoepidemiology studies.

Validation Workshop Activity: Participants will work hands-on with an online tool to determine how to adjust point estimates for outcome misclassification if PPV is known and sensitivity is known or can be assumed.

Linking pharmacoepidemiology resources: The lecture will provide guidance on key aspects of data linkage appropriateness and feasibility necessary to plan useful and sustainable linkages that advance pharmacoepidemiology and patient safety. The presentation will highlight recent advances undertaken across the society.