Interface between regulation and statistics in drug development
With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the…
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- Full title :Interface between regulation and statistics in drug development / Demissie Alemayehu, Birol Emir, Michael Gaffney.
Summary
With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. Features: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory interactions Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors' decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.
Read More ↓Edition Statements
- Publication Date:2021.
- Edition:1st
Publication Statements
- Publisher(s):Chapman & Hall/CRC
- Place of Publication:Boca Raton
- Language:eng
- Publication Date:2021.
The Physical Object
- Description:1 online resource : : illustrations (black and white)
Edition Identifiers
- ISBN:9781000215908, 1000215903, 9781000215700, 1000215709, 9781000215809, 1000215806, 9781003044208, 1003044204
- DOI:10.1201/9781003044208
- oclc:on1202853140
- LC Classification:RM301.27
- Dewey Decimal:615.10724
Table of Contents
Cover -- Half Title -- Series Information -- Title Page -- Copyright Page -- Table of contents -- Figures -- Abbreviations -- Authors' Disclosure -- Acknowledgment -- Preface -- About the Authors -- Chapter 1 Fundamental Principles of Clinical Trials -- 1.1 Introduction -- 1.2 General Statistical Considerations -- 1.2.1 Statistical Analysis Plan -- 1.2.2 Trial Design -- 1.2.3 Randomization and Blinding -- 1.2.4 Statistical Methodology -- 1.2.5 Reporting and Interpretation of Study Results -- 1.2.6 Data Quality and Software Validity -- 1.3 Evolving Roles of the Statistician in Drug Development
1.4 Potential Statistical Issues in Regulatory Review -- 1.4.1 Data Quality -- 1.4.2 Endpoint Definition -- 1.4.3 Design and Analysis Issues -- 1.4.4 Evaluation of Safety -- 1.4.5 Analysis Populations and Subgroups -- 1.4.6 Assessing Interpretation and Reliability of Results -- 1.5 Concluding Remarks -- Bibliography -- Chapter 2 Selected Statistical Topics of Regulatory Importance -- 2.1 Introduction -- 2.2 Multiplicity -- 2.2.1 Multiple Endpoints -- 2.2.2 Multiple Testing Over the Course of the Study -- 2.3 Missing Values and Estimands -- 2.3.1 General Considerations
2.3.2 Missingness Mech…
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