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药物研发及临床研究中的试验设计应用

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发表于 2018-9-27 22:51:43 | 显示全部楼层 |阅读模式
Definition
Complex innovative trial designs (CID) –including the use of adaptive, Bayesian, and other novel statistical approaches– mayhelp streamline and advance drug development and inform regulatorydecision-making. Both the Prescription Drug User Fee Amendments of2017 (PDUFA VI) and the 21st Century Cures Act contain provisions to make theuse of CID in drug development and regulatory decision-making easier.
Then What is the role of CID in drug development?
The drug development landscape is evolving and as a result, weare faced with both challenges and opportunities. We need to maximize clinicaltrial efficiency, while using scientifically sound methods to determine theoptimal design for the question and population of interest. To date, CID hasprimarily been used in exploratory studies. FDA’s goal is to extend their useto trials intended to provide substantial evidence of effectiveness to supportregulatory approval of new therapies.
显然,国外的药物研发及临床实验研究中,CID已经纳入了实践,并即将推广和使用,故此我们有必要总结一下其定义及应用:

复杂的创新试验设计(CID)——包括使用可修整设计应用、贝叶斯应用及其他新型统计方法——可能有助于简化和促进药物开发,并为监管决策提供信息
那么CID在药物研发中角色如何?
药品研发前景广阔,因而对业界而言挑战和机遇并存。监管方和从业者需要将临床试验效率最大化,因而使用科学方法以确定最佳方案设计。迄今为止,探索性临床试验研究已经应用CID策略。FDA的目标即将其扩展到新药品和新医疗举措的临床应用中,以便获得疗效的重要证据。

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