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Examining Bias in Lung Cancer Study Protocols: Lessons Learned from Multi-Stakeholders
Session Chair(s)
Jennifer Kim, PhD
Research Associate Professor
Tufts Center for the Study of Drug Development, United States
This session will be based on a recent effort that examined lung cancer studies to determine how and whether exclusion criteria could hinder the participation of racial minority patients. The panel will feature experts from sponsors, research sites, and academia to discuss challenges and areas of opportunities for re-thinking how to make lung cancer protocols more inclusive, and will include perspectives from the clinical operations, regulatory, research sites, and academia.
Learning Objective : Identify areas within a study protocol that can adversely exclude marginalized patient populations; Identify organizational challenges that may hinder redesign efforts, and the implications these challenges can have on the clinical operations and regulatory front; Discuss approaches, strategies, and lessons-learned to help simplify protocol design.
Speaker(s)
Perspectives from the Clinical Research Sites: Challenges Enrolling Racial Minority Participants
Julieta Argüelles, DrMed
MD Anderson Cancer Center, United States
Researcher
Sponsor Perspective: Overcoming Re-Design Efforts of Study Protocols
Kim Ribeiro, MS
Inside Edge Consulting Group, United States
Chief Client Officer
Application of Large Language Models (LLM) to Examine Lung Cancer Protocol Exclusion Criteria
Abigail Dirks, MS
Tufts Center for the Study of Drug Development, United States
Data Scientist
Sponsor Perspective: Implications of Protocol Complexity on Regulatory Oncology
Laura Huggins
Merck KGaA (EMD Serono), Germany
VP & Head, Global Regulatory Affairs Oncology & CDx
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