JSM 2005 - Toronto

Abstract #304002

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: 408
Type: Luncheons
Date/Time: Wednesday, August 10, 2005 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304002
Title: Registration of Trials and Reporting of Results: Old Concerns or New Trends?
Author(s): C. V. DamarAju*+
Companies: Ortho-McNeil Pharmaceuticals, Johnson & Johnson
Address: , Raritan, NJ, 08869, United States
Keywords: Registration of trials ; Reporting of results ; public health ; safety concerns ; publication
Abstract:

Recent requests for registration of trials and reporting of results in light of safety concerns from drugs in wide use mark an interesting challenge for data analysts and statisticians. They will be required to address an increasing amount of questions from regulatory agencies and publications. Some of the best industry practices can be fine tuned easily to address issues arising from such requests.


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Revised March 2005