戻る Agenda
Session 5: Health Equity in Drug Development: Leveraging RWD to Inform and Improve Diversity
Session Chair(s)
Brittany Avin McKelvey, PhD
Director, Regualtory Affairs
Friends of Cancer Research, United States
Historically, clinical trials lack inclusion and representativeness that may hinder the generalizability of results to the intended patient population and contribute to existing health inequities. Real-world data (RWD) can provide context and insights both to set appropriate goals for diversity in clinical research, as well as provide additional information on diverse patient populations. This session will discuss the types of data and evaluation of appropriate data sources to define diversity, inclusion, and representativeness, with a special focus on Social Determinants of Health and health equity, and how to incorporate RWD to enhance drug development for a more comprehensive view of the population of interest.
Learning Objective : - Identify what factors should be captured in RWD sources to define representativeness, diversity, and inclusion
- Describe how to leverage RWD and mitigate biases to generate insights on diversity and representativeness for a variety of research objectives in drug development
- Demonstrate example applications of RWD to build diverse and inclusive study populations across drug development strategies
Speaker(s)
Implementing Diversity Action Plans: Current Experience and Future Opportunities
Brittany Avin McKelvey, PhD
Friends of Cancer Research, United States
Director, Regualtory Affairs
Representative of What? Pragmatic Strategies to Improve Diversity and Inclusion When the Research Questions Demand it
Melinda Baker, PhD
Mission Health Labs, Inc. (dba PicnicHealth), United States
Director of Dataset Strategy & Commercialization
Discovering Patient Barriers in Real-World Data to Inform Diversity Strategies
P. Karina D'Angelo, PhD
Parexel, United States
Director, Scientific Data Strategy
Lessons Learned: Health Equity in Medicare Claims Data Research
Representative Invited
FDA, United States