JSM 2003 Online Program

Abstract #300166

This is the preliminary program for the 2003 Joint Statistical Meetings in San Francisco, California. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 2-5, 2003); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

To View the Program:
You may choose to view all activities of the program or just parts of it at any one time. All activities are arranged by date and time.

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 2003 Program page

Activity Number:	376
Type:	Contributed
Date/Time:	Wednesday, August 6, 2003 : 10:30 AM to 12:20 PM
Sponsor:	Biopharmaceutical Section
Abstract - #300166
Title:	Early Trials to Establish Safety with Respect to Rare, Serious Adverse Events
Author(s):	Alfred H. Balch*+
Companies:	Novartis Pharmaceuticals
Address:	59 Route 10, East Hanover, NJ, 07936,
Keywords:	sequentialmethods ; equivalencetrials ; Bayesian designs ; adaptive trials ; surrogate markers
Abstract:	To address regulatory concerns, and to evaluate developability, some drugs are required to undergo scrutiny early in development with respect to rare, serious adverse events. These are events which may have occurred in other marketed drugs with similar mechanisms of action or for drugs in the same class. We will investigate some methods of addressing these concerns along with their practicability and and practicality.

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 2003 program