【摘 要】
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In the last 10-15 years,after an implementation of the ICH-E9 guideline entitled "Statistical Principles for Clinical Trials",there has been an increasing a
【机 构】
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Department of Biomedical Statistics Osaka University Graduate School of Medicine Japan
【出 处】
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中国上海第七届国际新药发明科技年会
论文部分内容阅读
In the last 10-15 years,after an implementation of the ICH-E9 guideline entitled "Statistical Principles for Clinical Trials",there has been an increasing awareness of values of statistical contributions to a broader range of drug development process (not only for clinical trials,but for pharmaceutical research and development in general).Then the role,responsibility and carrier opportunities of statisticians involved in the process have been considerably extended.So far most statisticians have learned the principles and techniques in designing and managing clinical trials or planning development strategy of a new drug from an experience with rather less formal training.These have highlighted the need for formal professional development of statisticians.In this presentation,a key area of focus is the education of statisticians and their transition from university into working in the pharmaceutical related field and the preparation for the next generation of statisticians for our brightest future.
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