Consensus and controversy in pharmaceutical statistics
Consensus and controversy in pharmaceutical statistics
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DOI：
10.1111/1467-9884.00227
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发表时间：
2000-01-01
期刊：
影响因子：
--
通讯作者：
Senn, S
中科院分区：
文献类型：
--
作者：
Senn, S
药物开发是一项受到严格监管的业务。统计学在衡量和报告药物疗效和耐受性方面发挥着重要作用，这在美国、欧洲、日本和国际指南中得到了体现，这些指南相当详细，涵盖了临床试验的计划、运行和分析方式。分析的主导框架是频率论，但贝叶斯方法正变得越来越流行。根据国际协调会议 1999 年的国际统计指南，考虑药物开发中的一些有争议的问题，看看是否可能达成贝叶斯频率论共识。
Drug development is a highly regulated business. Statistics plays an important part in measuring and reporting the efficacy and tolerability of pharmaceuticals and this is reflected in American, European, Japanese and international guidelines of some considerable detail which cover the way in which clinical trials are to be planned, run and analysed, The dominant framework for analysis is frequentist but Bayesian approaches are becoming more popular. Some controversial issues in drug development are considered in the light of the International Conference on Harmonisation's 1999 international statistical guidelines to see whether any Bayes-frequentist consensus is possible.