STATISTICAL ISSUES IN THE DRUG EVALUATION PROSESS : SOME ISSUES IN APPLYING THE ICH GUIDELINES(Clinical and Medical Evaluation Process)

The International Conference on Harmonization (ICH) has recently developed the ICH guidelines, which are the common guidelines for regulatory requirements in the ICH regions, i.e. Japan, and the United States (US) and Europe. The guidelines have been implemented in the three regions, and the people involved in drug evaluation in the pharmaceutical industry, such as statisticians and pharmaceutical scientists, have referred the guidelines to their daily work when they perform the drug evaluation process. This paper aims to discuss some statistical issues in the drug evaluation process that are commonly encountered when applying the ICH guidelines. It also provides a few practical ideas for the future drug evaluation process. In this paper the emphasis is placed on the following ICH guidelines: "Dose-Response Information to Support Drug Registration" (ICH-E4), "Ethnic Factors in the Acceptability of Foreign Clinical Data" (ICH-E5) and "Choice of Control Group in Clinical Trials" (ICH-E10).