Abstract

After an overview of FDA’s draft guidances to industry on adaptive designs and enrichment strategies for clinical trials, we describe recent advances in adaptive confirmatory trial designs and statistical methods for their analysis. We then focus on biomarker-guided personalized therapies in the era of precision medicine, and precision-guided drug development and master protocols, and conclude with innovations in statistical science for precision medicine and regulatory submission.

中文翻译：

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精密医学时代的新型临床试验设计和统计方法

摘要

在概述了FDA的针对临床试验的适应性设计和丰富化策略行业指南草案之后，我们描述了适应性验证性试验设计及其统计方法的最新进展。然后，我们将重点放在精密医学时代的生物标记物指导的个性化疗法，精密指导药物的开发和总体规程上，并以精确科学和监管提交方面的统计科学创新作为结尾。