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Activity Number: 25
Type: Topic Contributed
Date/Time: Sunday, August 4, 2013 : 2:00 PM to 3:50 PM
Sponsor: Section on Statistics in Epidemiology
Abstract - #307638
Title: Analytical and Clinical Validation of Diagnostic Devices with Underlying High-Dimensional Input Data
Author(s): Zhiheng Xu*+ and Tinghui Yu and Meijuan Li and Lakshmi Vishnuvajjala
Companies: FDA and FDA/CDRH and FDA/CDRH and FDA/CDRH Division of Biostatistics
Keywords: High dimensional data ; diagnostic device ; Analytical Validation ; Clinical Validation

Qualitative diagnostic devices with underling high dimensional input data have become more common owing to the recent rapid development in molecular technology. There are many complex statistical issues in both study design and analysis on how to clinically and analytically validate those types of diagnostic devices. To the best of our knowledge, no literature is available to address these statistical challenges. In this talk, we aim to discuss statistical issues and challenges and provide some methods on how to address these issues.

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

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