000			07155cam a22007211i 4500
001			9781003044208
003			FlBoTFG
005			20220509193034.0
006			m d
007			cr |||||||||||
008			200903s2021 flua ob 000 0 eng d
040			_aOCoLC-P _beng _erda _epn _cOCoLC-P
020			_a9781000215908 _q(ePub ebook)
020			_a1000215903 _q(ePub ebook)
020			_a9781000215700 _q(PDF ebook)
020			_a1000215709 _q(PDF ebook)
020			_a9781000215809 _q(Mobipocket ebook)
020			_a1000215806 _q(Mobipocket ebook)
020			_a9781003044208 _q(ebook)
020			_a1003044204 _q(ebook)
020			_z9780367490485 (hbk.)
020			_z036749048X
024	7		_a10.1201/9781003044208 _2doi
035			_a(OCoLC)1202853140 _z(OCoLC)1197867940 _z(OCoLC)1198016261
035			_a(OCoLC-P)1202853140
050		4	_aRM301.27
072		7	_aMED _x090000 _2bisacsh
072		7	_aMAT _x029000 _2bisacsh
072		7	_aMED _x071000 _2bisacsh
072		7	_aMBGR1 _2bicssc
082	0	4	_a615.10724 _223
100	1		_aAlemayehu, Demissie, _eauthor.
245	1	0	_aInterface between regulation and statistics in drug development / _cDemissie Alemayehu, Birol Emir, Michael Gaffney.
250			_a1st.
264		1	_aBoca Raton : _bChapman & Hall/CRC, _c2021.
300			_a1 online resource : _billustrations (black and white).
336			_atext _2rdacontent
336			_astill image _2rdacontent
337			_acomputer _2rdamedia
338			_aonline resource _2rdacarrier
490	1		_aChapman & Hall/CRC biostatistics series
505	0		_aCover -- 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
505	8		_a1.4 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
505	8		_a2.3.2 Missingness Mechanisms -- 2.3.3 Approaches for Missing Data -- 2.3.4 Sensitivity Analyses -- 2.3.5 Estimands and Other Recent Regulatory Developments -- 2.3.6 Concluding Remarks -- 2.4 Non-inferiority Study -- 2.4.1 Efficacy Objective -- 2.4.2 Non-inferiority Hypothesis / Non-inferiority Margin -- 2.4.3 Determination of NIM -- 2.4.4 Example: FDA Guidance Document -- 2.4.5 Implications of Choice of NIM -- 2.4.6 Strength of a Non-inferiority Study -- 2.4.7 Synthesis Method for Non-inferiority -- 2.4.8 Summary Points -- 2.4.9 Non-inferiority Study with a Safety Objective
505	8		_a2.4.10 Summary Points -- 2.5 Innovative Trial Designs -- 2.5.1 Adaptive Designs -- 2.5.2 Adaptive Randomization -- 2.5.3 Sample Size Reestimation -- 2.5.4 Sequential Designs -- 2.5.5 Adaptive Designs for Dose and Treatment Selection -- 2.5.6 Adaptive Enrichment Designs -- 2.5.7 Master Protocols -- 2.5.7.1 Basket Trials -- 2.5.7.2 Umbrella Trials -- 2.5.7.3 Platform Trials -- 2.5.7.4 Regulatory and Operational Considerations with Novel Trials -- 2.6 Bayesian Analysis in a Regulatory Framework -- 2.6.1 Introduction -- 2.6.2 Potential Areas of Application -- 2.6.3 Regulatory Considerations
505	8		_a2.6.4 Challenges with Bayesian Statistics -- 2.6.5 Concluding Remarks -- 2.7 Surrogate Endpoints and Biomarkers -- 2.7.1 Introduction -- 2.7.2 Statistical Considerations -- 2.7.3 Regulatory Considerations -- 2.7.4 Concluding Remarks -- 2.8 Subgroup Analyses -- 2.8.1 Introduction -- 2.8.2 Subgroup Analyses in the Traditional Confirmatory Clinical-Trial Setting -- 2.8.3 Statistical Approaches -- 2.8.4 Reporting and Interpretation of Subgroup Results -- 2.8.5 Subgroup Analyses in the Changing Clinical-Trial and Regulatory Setting -- 2.8.6 Conclusion -- 2.9 Benefit-Risk Assessment
520			_aWith 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.
588			_aOCLC-licensed vendor bibliographic record.
610	1	0	_aUnited States. _bFood and Drug Administration _xRules and practice.
650		0	_aDrugs _zUnited States _xTesting _xStatistical methods.
650		0	_aDrugs _xTesting _xLaw and legislation _zUnited States.
650		0	_aClinical trials _zUnited States _xStatistical methods.
650		0	_aClinical trials _xLaw and legislation _zUnited States.
650		0	_aClinical trials _xReporting _zUnited States.
650		0	_aDrug development _zUnited States.
650		0	_aPharmaceutical policy _zUnited States.
650		7	_aMEDICAL / Biostatistics _2bisacsh
650		7	_aMATHEMATICS / Probability & Statistics / General _2bisacsh
650		7	_aMEDICAL / Pharmacology _2bisacsh
700	1		_aEmir, Birol, _eauthor.
700	1		_aGaffney, Michael, _dactive 1983, _eauthor.
856	4	0	_3Taylor & Francis _uhttps://www.taylorfrancis.com/books/9781003044208
856	4	2	_3OCLC metadata license agreement _uhttp://www.oclc.org/content/dam/oclc/forms/terms/vbrl-201703.pdf
999			_c128666 _d128666