JSM Preliminary Online Program
This is the preliminary program for the 2008 Joint Statistical Meetings in Denver, Colorado.

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Activity Number: 408
Type: Roundtables
Date/Time: Wednesday, August 6, 2008 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #302191
Title: Applying Lean Six Sigma Concepts to Adaptive Trial Logistics
Author(s): Darcy Hille*+ and Paulette Ceesay
Companies: Merck & Co., Inc. and Merck & Co., Inc.
Address: Mailstop UG1C-46, North Wales, PA, 19454,
Keywords: adaptive clinical trials ; Lean Six Sigma
Abstract:

Adaptive trials are clinical trials that use data not available at study start as a basis for modifications to the trial design. Lean Six Sigma is a business improvement methodology that stresses both efficiency and quality. Anticipating the complex logistics necessary for efficient, repeatable, adaptive trials, we are applying concepts from Lean Six Sigma to implement an adaptive randomization program at Merck. We hope to engage in a discussion about the challenges and successes involved in the application of Lean Six Sigma to the adaptive trial process.

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Revised September, 2008