Differences in Clinical Drug Development in Europe,Japan,and the United States: A Biostatistician's Perspective

Abstract

This paper presents some personal observations on the differences in biostatistical issues and the role of the biostatistician in Europe, Japan, and the United States. The evolution of biostatistical practices toward standardization in the three regions is also covered.

Keywords

Biostatistics Standardization Professional environment Clinical trial environment Regulatory environment

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References

Guidelines for the Format and Content of the Clinical and Statistical Sections of New Drug Applications. Center for Drug Evaluation and Research, Food and Drug Administration, Department of Health and Human Services: 1988.

PSI Professional Standards Working Party. Guideline Standard Operation Procedures for Good Statistical Practice in Clinical Research. January 22, 1993.

Commission of the European Communities.

CPMP Working Party on Efficacy of Medicinal Products. Biostatistical Methodology in Clinical Trials in Applications for Marketing Authorizations for Medicinal Products. March 1993.

Japanese Ministry of Health and Welfare. Guideline to Statistical Methods for Clinical Studies: Notification No. 20. March 4, 1992.

Tukey

. Use of Many Covariates in Clinical Trials. Inter Stat Rev. 1991;59:123–137.

NIH Guide for Grants and Contracts.

NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. January 28, 1994.

Center for Drug Evaluation and Research.

Guideline for the Study of and Evaluation of Gender Differences in the Clinical Evaluation of Drugs. Washington, DC: Food and Drug Administration; 1993.