Recommendations for Biostatistics of Mutagenicity Studies
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0092-86 15/97 Copyright 0 1997 Drug Information Association Inc.
Printed in the USA. All rights reserved.
RECOMMENDATIONS FOR BIOSTATISTICS OF MUTAGENICITY STUDIES* DIETERHAUSCHKE, PHD Byk Gulden, Germany
MAKOTOHAYASHI, Dsc National Institute of Health Sciences, Japan
KARLK. LIN, PHD Food and Drug Administration, United States
DAVIDP. LOVELL,PHD BIBRA International, United Kingdom
W. DAVIDROBINSON, Msc Glaxo Wellcome, United Kingdom
ISAOYOSHIMURA, PHD Science University of Tokyo, Japan
A Drug Information Association Workshop on “Statistical Methodology in Non-Clinical and Toxicological Studies” was held at the end of March 1996. The purpose of this meeting was to discuss and to obtain a consensus on the appropriateness of current and new biostatistical methods relevant in this field of drug development. The following summary represents a consensus of the Working Group on Biostatistics in Mutagenicity Studies. The recommendations outline the relevant principles of design and analysis rather than provide detailed specification of statistical methodology, thus providing the possibility of making reasonable choices between alternative approaches. Key Words: Mutagenicity; Biostatistics; Recommendations
RECOMMENDATIONS 1.
How can statistics contribute to the evaluation of test data? In the evalua-
*The views are those of the authors and not necessarily those of their employers. Presented at the DIA Workshop “Statistical Methodology in Non-Clinical & Toxicological Studies,” March 25-27, 1996, Bruges, Belgium. Reprint address: Dr. Dieter Hauschke, Department of Preclinical Biometry, Byk Gulden Pharmaceuticals, P. 0. Box 10 03 10, 78403 Konstanz, Germany.
tion of mutagenicity experiments, statistical methods should be used to support the decision on whether a result is negative or positive by: 0 Estimating effects, Investigating the dose-response relationship, Identifying sources of variation, Analyzing confounding factors, 0 Exploring the mechanisms of mutagenesis, and 0 Summarizing the data. Statistics should play a fundamental
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D. Hauschke, M. Hayashi, K. K. Lin, D. P. Lovell, W. D. Robinson, and I. Yoshimura
part in the adequate assessment of mutagenicity tests. Therefore, the statisticians should try to become a partner of the genetic toxicologists exchanging ideas from both sides, The study protocol is a critical document in the evaluation of an assay, shaping both the conduct of the study and the ultimate analysis of the assay. It sets forth the objectives of the study and relates these to the statistical methods that are used. A well-designed experimental protocol should normally include descriptions of the following statistical items: 0 Experimental design, 0 Designation of the experimental unit, 0 Randomization procedure, 0 Primary and secondary variables (endpoints), 0 Statistical analysis including: statistical model; test problem; statistical methods; sample size, type I and IT error; any adjustment due t
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