监管关键临床倡议的高级统计数据集中于2016年12月美国国会通过的《21世纪治愈法案》引入的关键临床倡议。这本书涵盖了从计划大纲到对生物制药研究和开发的影响分析的所有内容。监管关键临床倡议中的高级统计学为解决罕见疾病（如小样本）统计研究中的常见挑战提供了创新方法，并为数据的组合使用提供了指导。通过从监管和科学角度进行分析，本书是生物统计学、药物开发和相关领域决策者的理想伴侣。
主要特征
更好地理解创新设计和对每个关键临床计划的分析，这些计划可能用于药物开发的监管审查/批准。
提出建议，以准确可靠地评估提交的内容。
为肿瘤和/或罕见疾病药物开发提出创新的研究设计和统计方法。
提供有关基因治疗和罕见疾病等药物开发的当前监管指导的见解。
Advanced Statistics in Regulatory Critical Clinical Initiatives
Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields.
Key Features
Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development.
Makes recommendations to evaluate submissions accurately and reliably.
Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development.
Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.
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