New Frontiers for Pharmacoepidemiology: Using New and Mixed Methods for Data Collection

Course Aim
This live course will provide an overview and critical assessment of new approaches to prospective data collection in pharmacoepidemiology, looking beyond electric medical records (EMR) and health insurance claims to direct-to-"patient" data generation and data linkage. Uses of person-generated health data, including smartphone apps, wearables and social media, will be illustrated, with examples from COVID-19, rheumatology, and oncology. There will be active discussion about the value of these new approaches, when are they feasible and acceptable to patients, frequently encountered challenges, and how to recognize when these approaches are sufficiently fit for a particular objective.

Requisites Statement
Entry level.

Course Objectives
1. To understand how studies that use prospective data collection, without primary reliance on medical care professionals, and particularly from patient-generated sources and other sources can be designed and used to support research goals including evaluation of products approved via Emergency Use Authorization (EUA)
2. To recognize the methodologic and operational challenges of various use cases, including linkage of person-generated health data with other real-world data, and describe strategies used to address these challenges
3. To be aware of the strengths and limitations of these approaches, including the unique perspective that these different tools can provide

Syllabus Outline
1. Opportunities and barriers for collecting and linking patient-generated health data for research, illustrated through examples [Rachel Williams and Will Dixon ]
2. Using person-generated health data to understand long COVID-19 infections and vaccine side effects: Operational and scientific challenges and solutions [Nancy Dreyer]
3. Game-changing evidence generation: Learnings from Large-scale COVID-19 Monitoring Programs in Sport [Christina Mack]
4. Experiments in social media to better understand patient experiences and beliefs [Nabarum Dasgupta]