October 16, 2024 - October 17, 2024
Meet the U.S. Food and Drug Administration (FDA) 2024 guidance for Diversity Action Plans in your next clinical trial
Precision medicine and next-generation therapeutics have tremendous opportunity for accelerated speed-to-market through the generation of real-world evidence (RWE). With recent guidance released by the U.S. Food and Drug Administration (FDA, 2024) to increase participation by historically underrepresented populations, and with a patient-centric, whole person care approach requiring a holistic understanding outside of the clinical-trial environment, including longitudinal health history and social and environment context, RWE generation can be challenging.
Real-world evidence must represent a diverse and equitable population to generate outcomes and patient care standards that are generalizable and representative of the full population.
By participating in this course, you will:
- Gain insights on novel data sources, such as consumer data, that can provide holistic insights into health equity and social drivers of health.
- Learn how to integrate this data with additional data sources, including clinical or medical claims data, and effectively de-identified for HIPAA compliant research-ready analysis.
- Explore case studies of how this comprehensive, patient-centered data accelerates epidemiology research, patient journey analytics, and clinical trial design.
- Explore traditional approaches implementing RWD/RWE into decision making, along with their limitations.
- Discuss innovative approaches to mitigating the risks of ambiguous inference and leaving important populations out of next generation research.
Now is the time to move away from reliance on low resolution zip code or payer type figures to monitor the diversity of the dataset and begin using novel data sources that include important patient-level variables specific to evaluating health equity, such as access to care and transportation, socio-economic inequality, and household and social supports.
PREREQUISITE: Participants must understand social determinants, confounding, inference, basic research methods, and traditional care pathways.
LEVEL:
Introductory
TRACK:
Real World Data & Information Systems
HEOR Key Competency:
12. Patient-Centered Research
Faculty
Schedule:
LENGTH: 4 Hours | Course runs 2 consecutive days, 2 hours each day