SC-05 - Using pharmacoepidemiology database resources to address drug safety research

1. 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 consideration in selection of databases resources, consideration on the utilization of multiple data resources including linkage of available data resources, and addresses the need for validation.

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

3. Course Objectives
1. To review the Guidelines for Good Database Selection and use in Pharmacoepidemiology Research with a focus on how to construct computable phenotypes within available resources
2. To develop the skills to select an appropriate resource to conduct pharmacoepidemiology research
3. To gain an appreciation for the utilization of multiple pharmacoepidemiology data resources through distributed research methods and the available methods for data linkage of diverse data resources
4. To examine validation methods for assessing the quality of pharmacoepidemiology data sources

4. Syllabus Outline
1. Overview of Database use in Pharmacoepidemiology {40 minutes} Rosa Gini, PhD
ARS Toscana
The presentation will provide a preview of the ongoing update of the ISPE Guidelines for good database selection and use in pharmacoepidemiology research. The talk will provide an overview of the methods to measure study variables with computable phenotypes.

2. Selection of Databases for Pharmacoepidemiology Research {40 minutes} Matthew Reynolds, PhD Vice President, Real World Effectiveness at IQVIA
The presentation will review the process of database selection from available resources across an international landscape.

3. Database Selection Workshop Activity {20 minutes} Kevin Haynes, PharmD, MSCE,
Associate Director of Epidemiology at Janssen
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.

4. Multiple Pharmacoepidemiology Resource Research {40 minutes} Sudha Raman, PhD
Assistant Professor, Department of Population Health Sciences, Duke University
The lecture will provide guidance on two key aspects of multiple pharmacoepidmiology resource utilization 1. Distributed database research and 2. data linkage appropriateness and feasibility.

5. Data validation approaches in pharmacoepidemiology {30 minutes} Daniel Beachler, PhD Carelon Research, Inc.
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 {20 minutes}
Participants will work hands on with an on-line tool to determine how to adjust point estimates for outcome misclassification if PPV is known and sensitivity is known or can be assumed.