How to Achieve Standardization of Statistical Methods in Toxicology
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Drug Information Journal, Vol. 31, pp. 395-401, 1997 Printed in the USA. All rights reserved.
HOW TO ACHIEVE STANDARDIZATION OF STATISTICAL METHODS IN TOXICOLOGY GRAHAMF. HEALEY,MSc Head of Statistics, Huntingdon Life Sciences, Huntingdon, United Kingdom
The current diversity in statistical methodology for even quite simple situations is emphasized. The reasons for this diversity can be grouped into two broad categories: Cultural, including national preference, historical precedent, and resource availability; and statistical, including inadequacies in statistical theory, inadequate knowledge of the biological context, and other practical constraints. Although criteria for an ideal methodology could be defined, no current methods satisfy them and are therefore suboptimal. It is inferred that to attempt worldwide standardization on a particular statistical test in a particular situation ( “Standardization by Method”) is generally not desirable. A proposal will be made, howevel; that it should be possible to achieve standardization by the setting of “perf6rmance criteria” in order to classify proposed methods as “acceptable” or “unacceptable” (“Standardization by Performance”). Key Words: Statistical methodology; Standardization; Toxicology; Statisticalpower; Performance criteria
INTRODUCTION EFFORTS AT AN INTERNATIONAL level are currently being made to standardize procedures and methods in many areas of toxicology. In the statistical area, the first steps are being taken. The aim of this short article is to emphasize the current diversity in statistical methodology, and thereby infer that to attempt worldwide standardization on a particular statistical test in a particular situation (“Standardization by Method”) is generally not de-
This paper is based on a talk presented at the DIA Workshop “Statistical Methodology in Non-Clinical and Toxicological Studies,” March 25-27, 1996, Bruges, Belgium. Reprint address: Mr. Graham F. Healey, Statistics Department, Huntingdon Life Sciences, P.O. Box 2, Huntingdon, Cambs. PE18 6ES, UK.
sirable. A proposal will be made, however, that it should be possible to achieve a degree of standardization by the setting of “performance criteria” in order to classify proposed methods as “acceptable” or “unacceptable” (“Standardization by Performance”).
THE CURRENT DIVERSITY OF METHODS For even the simplest statistical situations, an extraordinary variety of methods may be employed by the many statisticians and institutions around the world. Given a new situation where statistical analysis is required, institutions will often ask their statisticians to develop appropriate methodology. The statisticians will in due course propose a method. For a particular set of data, a particular test can be proposed. In toxicology the more usual situation is that a routine method is
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needed which can cope with many data sets, from different studies and different biological parameters. The method
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