Clinical Trials Simulation: A Statistical Approach -- Biostatistics and Data Management Committee

Wed, October 3 12:00 pm – 2:00 pm

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<link media="all" type="text/css" href="http://massbio.org/sup/css/content.css" rel="stylesheet"> You are invited to join the MBC Biostatistics and Data Management Committee for a presentation on "Clinical Trials Simulation: A Statistical Approach"

When: Wednesday, October 3, 2007

Time: 12:00-2:00 PM

Where: MBC Office, One Cambridge Center, 9th Floor, Cambridge, MA


Clinical Trials Simulation: A Statistical Approach

Overview:
The goal of clinical trials simulation (CTS) is to improve clinical development by generating better insights into the consequences of the choices made in the design of human trials, especially at the planning stage. In the process of bringing a new compound to market, every mistake in study design can add millions of dollars in added expenses or cause delays that lead to lost revenues.

The focus of the presentation will be to provide a brief overview of multivariate statistical methods and grid computing solutions that can be used to perform clinical trials simulation. Statistical simulation methods shown will include doubly-multivariate endpoint/timepoint correlation structures, informative dropout mechanisms, non-normal distributions, survival endpoints, and noncompliance effects.

An example will be provided from a grid enabled custom clinical trial statistical software simulation application. The example will illustrate how these methods could be used to select an optimal study design from a series of possible choices.

Learning Objectives:
(1) Detailed knowledge of the statistical methods used to generate simulated clinical trial data.
(2) Awareness of the promise of clinical trials simulation to improve the design of human trials.
(3) Understanding the results yielded from application of these methods and grid computing to solve a "real-life" study design problem.

Speakers:
Peter Westfall, James and Marguerite Niver Professor of ISQS Texas Tech University

Paul Whitfield Horn Professor of Statistics, Texas Tech University and Editor, The American Statistician

Scott Moseley, Senior Director, Vertex Pharmaceuticals


We look forward to seeing you there!

Lunch will be served.

TO REGISTER:
email your name, title and company to register@massbio.org. Please include "BDM 10/3" in the subject line.
This event is free of charge and open to MBC Member companies and their employees only.

For more information on Membership, contact Lori Gold at lori.gold@massbio.org or 617-674-5149.

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