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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)
Sponsor Perspective: Implications of Protocol Complexity on Regulatory Oncology
Ritesh Jain, PHD
EMD Serono, United States
Senior Director
Perspectives from the Clinical Research Sites: Challenges Enrolling Racial Minority Participants
Umit Tapan, MD
Boston University, United States
Assitant Professor of Medicine
Sponsor Perspective: Overcoming Re-Design Efforts of Study Protocols
Kim Ribeiro, MS
Boehringer Ingelheim, United States
Director Patient Experience & Engagement
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
Senior Data Scientist
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