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Challenges and Issues in Early-Phase Oncology Trials
Session Chair(s)
Elaine Marie Paul, PHD
Senior Director Clinical Development
GlaxoSmithKline, United States
Subjects in early-phase oncology trials represent a special population, particularly in the age of precision medicine with many new therapies targeted to specific mutations or being developed for rare types of cancer. This session will provide background on how early-phase oncology trials are changing and some of the complex issues that arise in the design, implementation, and ethics of these trials.
Learning Objective : Explain how the paradigm of drug development in oncology is changing; Recognize complex issues inherent in the design, implementation, and ethics of early-phase oncology trials.
Speaker(s)
The Evolving Complexity of Early Phase Clinical Trials
Elaine Marie Paul, PHD
GlaxoSmithKline, United States
Senior Director Clinical Development
Challenges and Issues to Consider in the Implementation of Phase I Oncology Trials
Leanne Cartee, PHD
UNC Lineberger Cancer Center, United States
Director, Protocol Development
Oncology Trials: A Study in Adaptation
Sharon Cornell Murray, PHD
PAREXEL, United States
Associate Director, Biostatistics
Unique Ethical Issues in Early Stage Oncology Research
Lindsay McNair, MD, MPH, MS
Equipoise Consulting, United States
Principal Consultant