Event

10:00AM–12:00PM Eastern Daylight Time (EDT)

14:00PM–16:00PM Coordinated Universal Time (UTC)

16:00PM–18:00PM Central European Summer Time (CEST)

Precision medicine and next-generation therapeutics have tremendous opportunity for accelerated speed-to-market through the generation of real-world evidence (RWE). Patient-centric, whole person care requires a holistic understanding outside of the clinical-trial environment, including longitudinal health history and social and environment context. Furthermore, given the FDA’s 2022 guidance on increasing diversity in clinical trials, we must also ensure that any real-world evidence represents a diverse and equitable population, to generate outcomes and patient care standards that are generalizable and representative of the full population. Many RWD/RWE researchers rely on low resolution zip code or payer type figures to monitor the diversity of the dataset. However, this data lacks important variables specific to evaluating health equity, such as access to care and transportation, income inequality, and household and social supports.

This course will provide participants with insights on novel data sources, such as consumer data, that can provide holistic insights into health equity and social drivers of health. We will cover how this data can be integrated with additional data sources, including clinical or medical claims data, and effectively de-identified for HIPAA compliant research-ready analysis. Lastly, we will provide examples of how this comprehensive, patient-centered data accelerates epidemiology research, patient journey analytics, and clinical trial design. Traditional approaches implementing RWD/RWE into decision making, along with their limitations will be explored during this course. Finally, perspective on innovative approaches to mitigating the risks of ambiguous inference and leaving important populations out of next generation research will be offered.

PREREQUISITE: Participants must understand social determinants, confounding, inference, basic research methods, and traditional care pathways.