戻る Agenda
Meeting the Challenges of Health Care Disparities and Clinical Trial Requirements in the Global Environment
Session Chair(s)
Florence Houn, MD, MPH, FACP
Consultant
Florence Houn MD MPH LLC, United States
This session will identify expectations of industry for INDs and marketing applications regarding racial and ethnic enrollment into clinical trials, demographic analyses, and FDASIA requirements on FDA. It will also discuss policy implications for global development, health disparities, and meaningful inclusion of demographic subgroups (sex, race, ethnicity, age) and current Office of Minority Health initiatives in collaboration and advancing regulatory science.
Learning Objective : Discuss current Office of Minority Health initiatives in collaboration and advancing regulatory science; Identify expectations on industry for INDs and marketing applications regarding racial and ethnic enrollment into clinical trials, demographic analyses, and FDASIA requirements on FDA; Identify factors in addressing health disparities with global drug development.
Speaker(s)
The Challenge of the Generalizability of Clinical Data and Demographic Subgroups
Jonca Bull, MD
PPD, United States
Vice President, Regulatory Consulting
Regulatory Review Considerations for Demographic Subgroups: Representativeness and Interpretability of Results
Lisa LaVange, PHD
University of North Carolina at Chapel Hill, United States
Professor Emerita
Leveraging Industry's Global Clinical Trials to Reduce Health Disparities Via Data Generation and Capacity Building
Lisa Egbuonu-Davis, MD, MBA, MPH
Danaher Diagnostics Platform, United States
VP Medical Innovations