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Activity Number: 643 - Biomarkers and Clinical Trials
Type: Invited
Date/Time: Thursday, August 2, 2018 : 10:30 AM to 12:20 PM
Sponsor: WNAR
Abstract #326482 Presentation
Title: Using Surrogate Biomarker Information to Plan a Future Clinical Trial
Author(s): Layla Parast* and Tianxi Cai and Lu Tian
Companies: RAND and Harvard T.H. Chan School of Public Health and Stanford University School of Medicine
Keywords: surrogate; biomarker; nonparametric; power; testing

The development of methods to identify, validate and use surrogate biomarkers to test for a treatment effect has been an area of intense research interest given the potential for valid surrogate biomarkers to reduce the required costs and follow-up times of future studies. Several quantities and procedures have been proposed to assess the utility of a surrogate biomarker. However, few methods have been proposed to address how one might use the surrogate biomarker information to test for a treatment effect at an earlier time point or use biomarker information to plan a future clinical trial, especially in settings where the primary outcome and the biomarker are subject to censoring. We propose a novel nonparametric test statistic to test for a treatment effect using surrogate biomarker information measured prior to the end of the study in a time-to-event outcome setting. In addition, we propose a procedure to use surrogate biomarker information from an earlier trial to plan a future clinical trial and evaluate expected power and needed sample size. We illustrate the proposed procedures using simulation studies and clinical trial data.

Authors who are presenting talks have a * after their name.

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