JSM 2004 - Toronto

Abstract #300451

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Activity Number: 193
Type: Contributed
Date/Time: Tuesday, August 10, 2004 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #300451
Title: Application of Quality Control Statistics to Clinical Trials
Author(s): Terry L. Katz*+ and Hans Kroger
Companies: PRA International and PRA International
Address: 4 Industrial Way West, Eatontown, NJ, 07724,
Keywords: precision ; accuracy ; biostatistics ; quality control ; clinical relevance
Abstract:

By the time data from a clinical trial reaches a biostatistician for analysis it is commonly assumed to be of adequate quality. Onsite monitoring and double data entry seek to ensure the validity of data reported on the case report form, but inaccuracies, nonetheless, are commonplace. By adopting statistical quality control concepts from manufacturing that are used to ensure the precision and accuracy of measurement instruments, clinical data collection and review can be enhanced. Statistical process control methods, such as control charts, can detect outlier data values or trends, enabling early queries. These proactive methods would reduce the need to clean data at the analysis stage and the entire data management process would be improved. Examples of applications of these concepts to clinical data will include the accuracy and precision of vital sign measurements and routine (random) in-process data checks. The relevance of collected data to the patient's clinical condition, especially in relation to published expected normal ranges, will be considered.

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Revised March 2004