Cross-Validated STEPP Analysis for

Biomarker Subgroup Determination Gu Mi1,*, Tuan S. Nguyen1, Jonathan S. Denne2

1Global Statistical Sciences 2MDU - Oncology

Eli Lilly and Company, Indianapolis, IN

* mi_gu@lilly.com

The 39th annual Midwest Biopharmaceutical Statistics Workshop (MBSW)

May 17, 2016

Outline

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Background

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Objective

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Introduction to STEPP

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Mock Data Example for TO/SW STEPP

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Cross-Validated Profile Likelihood (CVPL)

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Tail-Oriented (TO) cvSTEPP

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Sliding Window (SW) cvSTEPP

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Why and How to Parallel Compute?

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A Simulated Phase III Oncology Trial

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Results: Tail-Oriented (TO) cvSTEPP

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Results: Sliding Window (SW) cvSTEPP

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Results: SW STEPP w/ optimal r1 = 35 and r2 = 140

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Discussion

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Future Works

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Acknowledgements

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Key References: STEPP Methodology and Applications

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Key References: Cross-Validation in Survival Analysis

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Key References: Parallel Computing

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Choice of Candidate Parameter(s)

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