JSM Preliminary Online Program
This is the preliminary program for the 2009 Joint Statistical Meetings in Washington, DC.

The views expressed here are those of the individual authors
and not necessarily those of the ASA or its board, officers, or staff.

Back to main JSM 2009 Program page

Activity Number: 103
Type: Topic Contributed
Date/Time: Monday, August 3, 2009 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #303710
Title: Statistical Practice and Post-Market Trials/Databases: Some Perspectives
Author(s): Gosford A. Sawyerr*+
Companies: Purdue Pharma, LP
Address: One Stamford Forum, Stamford, CT, 06901,
Keywords: post-market ; biopharmaceutical ; medical device ; trials ; design ; analysis
Abstract:

The statistician's role in approval of a new drug, biologic or medical device is well established. An NDA, PLA or PMA submission requires a measure of statistical rigor to establish efficacy and safety for the registration product. In many cases, the effectiveness/safety profile of an entity is made clearer only after considerable time on market. Further, at time of submission, trials may not adequately address issues that may not be advantageous to a sponsor. This talk will examine two aspects of statistical practice in the pharmaceutical/medical device arena as it relates to clinical development: what is the place of a post-market group within a statistics organization, and what statistical issues are encountered in the design and analysis of data obtained from post-market trials and/or surveillance databases.

  • The address information is for the authors that have a + after their name.
  • Authors who are presenting talks have a * after their name.

Back to the full JSM 2009 program


JSM 2009 For information, contact jsm@amstat.org or phone (888) 231-3473. If you have questions about the Continuing Education program, please contact the Education Department.
Revised September, 2008