DIA 2025 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-653-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Jennifer Kim, PhD

Speaker

Sponsor Perspective: Implications of Protocol Complexity on Regulatory Oncology
Ritesh Jain, PhD

Perspectives from the Clinical Research Sites: Challenges Enrolling Racial Minority Participants
Umit Tapan, MD

Sponsor Perspective: Overcoming Re-Design Efforts of Study Protocols
Kim Ribeiro, MS

Application of Large Language Models (LLM) to Examine Lung Cancer Protocol Exclusion Criteria
Abigail Dirks, MS