JSM 2004 - Toronto

Abstract #301332

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Activity Number: 29
Type: Contributed
Date/Time: Sunday, August 8, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301332
Title: Application of Statistical Sampling Principles to Clinical Trial Management
Author(s): Guy Cohen and Cynthia Siu*+ and Isma Benattia and Darryl Penenberg and Vito Calamia and Joan Rex and Christine Clemente
Companies: Pfizer Inc. and Roche Pharmaceuticals and Wyeth Pharmaceuticals and Pfizer Pharmaceuticals and Pfizer Pharmaceuticals and Wyeth Pharmaceuticals and Pfizer Pharmaceuticals
Address: 340 Kingland St., Nutley, NJ, 07110,
Keywords: clinical trials ; study management ; Deming sampling methods
Abstract:

As clinical trials have become larger, more lengthy, and more complex, due to the nature of the diseases and conditions under study, it is necessary to use statistical sampling principles (Deming's enumerative study framework) in order to ensure efficient clinical trial management and contain spiraling R&D costs and assure quality. Sampling plans and sampling methods can be developed to randomly pre-select investigation sites for auditing and close monitoring (monitoring reports). Similar statistical sampling methods can be utilized to assure study integrity, quality control for data collection, database cleaning, and tables in final study report. This paper will describe a sampling scheme and show how it will avoid pitfalls of trying to achieve 100% quality control while preserving the responsibility required of all new drug sponsors: to ensure that the study meets or exceeds all GCP and all regulatory requirements.

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Revised March 2004