JSM 2005 - Toronto

Abstract #304394

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 279
Type: Luncheons
Date/Time: Tuesday, August 9, 2005 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304394
Title: Screening or Diagnostic Imaging Devices: Statistical Assessment of Effectiveness
Author(s): Harry Bushar*+
Companies: U.S. Food and Drug Administration
Address: 1350 Piccard Drive, Rockville, MD, 20850, United States
Keywords: Screening, Diagnostic ; Sensitivity ; Specificity ; Enriched Sample ; Cancer
Abstract:

We will discuss the Center for Devices and Radiological Health (CDRH), a required statistical evaluation to establish the safety and effectiveness of a new screening or diagnostic imaging device. We will focus on appropriate statistical methodology for use in testing the statistical hypothesis corresponding to the objective of the clinical study, which is designed to establish the sensitivity and specificity of an imaging device or to compare a new imaging device to an already-approved imaging device. In particular, we will consider the proper use of an enriched sample drawn from a population in which the disease to be detected, such as cancer, is relatively rare.

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Revised March 2005