Tuesday, June 20 • 4:00pm - 5:15pm
#282: Challenges and Issues in Early-Phase Oncology Trials

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-550-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Elaine Marie Paul, PhD


The Evolving Complexity of Early Phase Clinical Trials
Elaine Marie Paul, PhD

Challenges and Issues to Consider in the Implementation of Phase I Oncology Trials
Leanne Cartee, PhD

Oncology Trials: A Study in Adaptation
Sharon Cornell Murray, PhD

Unique Ethical Issues in Early Stage Oncology Research
Lindsay McNair

avatar for Elaine Paul

Elaine Paul

Senior Director Clinical Development, GlaxoSmithKline
Elaine Paul is a Senior Director of Clinical Development at GSK and is currently leading the development of an immuno-oncology monoclonal antibody. Elaine has 28 years experience in clinical development including first in human through registration directed studies and in several... Read More →

avatar for Leanne Cartee

Leanne Cartee

Director, Protocol Development, UNC Lineberger Cancer Center
Dr. Cartee is Director of Protocol Development at the Univ of North Carolina Lineberger Comprehensive Cancer Center. She supports investigator-initiated studies and serves as liaison for collaborations with industry and other research partners. Dr. Cartee is a former employee of GlaxoSmithKline... Read More →
avatar for Lindsay McNair

Lindsay McNair

Chief Medical Officer, WIRB-Copernicus Group (WCG)
Lindsay McNair, MD, MPH, MSBioethics is the Chief Medical Officer for the WIRB-Copernicus Group. She oversees the physician team within the WCG IRBs, and provides consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol design, regulatory... Read More →
avatar for Sharon Murray

Sharon Murray

Associate Director, Biostatistics, PAREXEL
Sharon Murray is Associate Director, Statistics at PAREXEL Ltd. She provides statistical support for the design, analysis and operational aspects of Oncology clinical trials as well as for drug development strategy. Sharon holds an MS and PhD in Biostatistics from the University of... Read More →

Tuesday June 20, 2017 4:00pm - 5:15pm
S504abc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616