JSM 2005 Online Program

Abstract #304382

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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Activity Number:	444
Type:	Topic Contributed
Date/Time:	Wednesday, August 10, 2005 : 2:00 PM to 3:50 PM
Sponsor:	Biopharmaceutical Section
Abstract - #304382
Title:	Design and Analysis of the Postmarket Surveillance Study in Medical Device Industry
Author(s):	Chi-Hong Tseng*+
Companies:	New York University
Address:	650 1st Ave., 5th floor, New York, NY, 10016, United States
Keywords:	survival anaylsis ; postmarket surveillance study ; biased sampling
Abstract:	A Postmarket surveillance (PMS) study is intended to discover device safety data that could not have been obtained through clinical trials and hence serves as an early warning for problems with the marketed device. A typical setting involves a primary sample of all devices from a company database and a validation subsample from the postmarket surveillance study. The primary sample usually contains rough and biased information because of the patients' loss to followup and device failure underreporting, while the validation subsample consists of up-to-date and correct information. We propose a biased sampling design to conduct postmarket surveillance study, where the inclusion probability of devices in the validation subsample is based on the company data. A nonparametric approach will be proposed to estimate the medical device survival function. Simulation results will be presented to evaluate the proposed estimator and the efficiency of this design.

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