Interface between regulation and statistics in drug development / (Record no. 72806)
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| fixed length control field | 07184cam a22007331i 4500 |
| 001 - CONTROL NUMBER | |
| control field | 9781003044208 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20220531132454.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| fixed length control field | m d |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 200903s2021 flua ob 000 0 eng d |
| 040 ## - Cataloging Source | |
| -- | OCoLC-P |
| -- | eng |
| -- | rda |
| -- | pn |
| -- | OCoLC-P |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781000215908 |
| -- | (ePub ebook) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1000215903 |
| -- | (ePub ebook) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781000215700 |
| -- | (PDF ebook) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1000215709 |
| -- | (PDF ebook) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781000215809 |
| -- | (Mobipocket ebook) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1000215806 |
| -- | (Mobipocket ebook) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781003044208 |
| -- | (ebook) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1003044204 |
| -- | (ebook) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9780367490485 (hbk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 036749048X |
| 024 7# - | |
| -- | 10.1201/9781003044208 |
| -- | doi |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)1202853140 |
| Canceled/invalid control number | (OCoLC)1197867940 |
| -- | (OCoLC)1198016261 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC-P)1202853140 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RM301.27 |
| 072 #7 - | |
| -- | MED |
| -- | 090000 |
| -- | bisacsh |
| 072 #7 - | |
| -- | MAT |
| -- | 029000 |
| -- | bisacsh |
| 072 #7 - | |
| -- | MED |
| -- | 071000 |
| -- | bisacsh |
| 072 #7 - | |
| -- | MBGR1 |
| -- | bicssc |
| 082 04 - | |
| -- | 615.10724 |
| -- | 23 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Alemayehu, Demissie, |
| Relator term | author. |
| 245 10 - TITLE STATEMENT | |
| Title | Interface between regulation and statistics in drug development / |
| Statement of responsibility, etc. | Demissie Alemayehu, Birol Emir, Michael Gaffney. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 1st. |
| 264 #1 - | |
| -- | Boca Raton : |
| -- | Chapman & Hall/CRC, |
| -- | 2021. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource : |
| Other physical details | illustrations (black and white). |
| 336 ## - | |
| -- | text |
| -- | rdacontent |
| 336 ## - | |
| -- | still image |
| -- | rdacontent |
| 337 ## - | |
| -- | computer |
| -- | rdamedia |
| 338 ## - | |
| -- | online resource |
| -- | rdacarrier |
| 490 1# - | |
| -- | Chapman & Hall/CRC biostatistics series |
| 505 0# - | |
| -- | 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 |
| 505 8# - | |
| -- | 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 |
| 505 8# - | |
| -- | 2.3.2 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# - | |
| -- | 2.4.10 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# - | |
| -- | 2.6.4 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 ## - | |
| -- | 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. |
| 588 ## - | |
| -- | OCLC-licensed vendor bibliographic record. |
| 610 10 - SUBJECT ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | United States. |
| Subordinate unit | Food and Drug Administration |
| General subdivision | Rules and practice. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drugs |
| Geographic subdivision | United States |
| General subdivision | Testing |
| -- | Statistical methods. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drugs |
| General subdivision | Testing |
| -- | Law and legislation |
| Geographic subdivision | United States. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Clinical trials |
| Geographic subdivision | United States |
| General subdivision | Statistical methods. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Clinical trials |
| General subdivision | Law and legislation |
| Geographic subdivision | United States. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Clinical trials |
| General subdivision | Reporting |
| Geographic subdivision | United States. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drug development |
| Geographic subdivision | United States. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmaceutical policy |
| Geographic subdivision | United States. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL / Biostatistics |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MATHEMATICS / Probability & Statistics / General |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL / Pharmacology |
| Source of heading or term | bisacsh |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Emir, Birol, |
| Relator term | author. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Gaffney, Michael, |
| Dates associated with a name | active 1983, |
| Relator term | author. |
| 856 40 - | |
| -- | Taylor & Francis |
| -- | https://www.taylorfrancis.com/books/9781003044208 |
| 856 42 - | |
| -- | OCLC metadata license agreement |
| -- | http://www.oclc.org/content/dam/oclc/forms/terms/vbrl-201703.pdf |
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