SC-16 - New frontiers for pharmacoepidemiology: Cutting edge approaches to data collection and integration

1. Course Aim

This lively course will provide an overview and critical assessment of new and opportunistic uses of real-world data in pharmacoepidemiology, including data linkage, person-generated health data to evaluate vaccine safety, filling in missing data with AI-powered extraction and estimation from unstructured data and digital phenotyping, and using repurposed occupational health data from professional sports to support medical product label expansions. There will be active discussion about the value of these new approaches, when are they feasible and acceptable to patients, clinicians and regulators, frequently encountered challenges, and how to recognize when these approaches are sufficiently fit for a particular objective.
2. Requisites Statement
Entry level

3. Course Objectives
1) To understand how studies that use prospective data collection can be designed and used to support research goals, with a focus on data collected without primary reliance on medical care professionals and with a focus patient-generated health data and other sources
2) To be able to explain some methodologic and operational challenges of various use cases, including data curation and linkage of person-generated health data with other real-world data, and review strategies used to address these challenges
3) To be aware of the strengths and limitations of these approaches, including the unique perspectives that these different tools offer

4. Syllabus Outline
1. Understanding the basics of RWD linkage and how it can be used to strengthen pharmacoepidemiology, with examples from vaccine safety [Nancy Dreyer]
2. How to generate reusable evidence: examples of leveraging novel technologies for flexible studies and diverse stakeholders [Kristen Hahn]
3. New techniques for learning more from existing data, including filling in missing data with AI-powered extraction and estimation from unstructured data and digital phenotyping [Joe Zabinski]
4. Game-changing evidence generation: How RWD from professional sports has been used to advance regulatory decisions on medical devices [Christina Mack]