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Bethesda North Marriott Hotel and Conference Center

Oct 01, 2015 7:30 AM - Oct 02, 2015 2:45 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Imaging in Oncology Clinical Trials: Central Audit Methods for Site Interpretation

Participate in cross-functional discussions about current audit method options and discuss how to implement audit plans for site image.

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Session 3: Statistical Session (Theoretical)

Session Chair(s)

Steven Sun, PhD

Steven Sun, PhD

Director, Janssen R&D, United States

Since the July 2012 ODAC (Oncologic Drug Advisory Committee) Meeting on "Evaluation of Radiologic Review of Progression-free Survival in Non-Hematologic Malignancies," two audit methods, the “Pharm method” and the “NCI method” have been widely used. This session will provide a comprehensive review of these two audit methods and highlight recent progress on new methodologies. The focus will be on the merits and challenges of each method and more importantly on recommendations for when to use which method.

Speaker(s)

Ohad Amit

Ohad Amit

Senior Director, Clinical Statistics, GlaxoSmithKline, United States

Independent Review of Progression-free Survival: Progress and Pitfalls

Euan J. MacPherson, MSc

Euan J. MacPherson, MSc

Principal Statistician, AstraZenca, United Kingdom

Model Free Audit Methodology for Bias Evaluation of Tumor Progression in Oncology

Panel Q&A

Panel Q&A

, United States

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