Statistical Approaches in Oncology Clinical Development : (Record no. 129884)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 05360nam a2200493Ii 4500 |
| 001 - CONTROL NUMBER | |
| control field | 9781315154435 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | FlBoTFG |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20220509193112.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION | |
| fixed length control field | m o d |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 190122s2018 fluab ob 001 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781315154435(e-book : PDF) |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)1066115091 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | FlBoTFG |
| Transcribing agency | FlBoTFG |
| Description conventions | rda |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RC271 |
| Item number | .C5 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MAT |
| Subject category code subdivision | 029000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 090000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 071000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | PBT |
| Source | bicscc |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 616.99/4061 |
| Edition number | 23 |
| 245 00 - TITLE STATEMENT | |
| Title | Statistical Approaches in Oncology Clinical Development : |
| Remainder of title | Current Paradigm and Methodological Advancement / |
| Statement of responsibility, etc | edited by Satrajit Roychoudhury and Soumi Lahiri. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | First edition. |
| 264 #1 - | |
| -- | Boca Raton, FL : |
| -- | Chapman and Hall/CRC, |
| -- | 2018. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource (236 pages) : |
| Other physical details | 79 illustrations, text file, PDF. |
| 336 ## - | |
| -- | text |
| -- | rdacontent |
| 337 ## - | |
| -- | computer |
| -- | rdamedia |
| 338 ## - | |
| -- | online resource |
| -- | rdacarrier |
| 490 1# - SERIES STATEMENT | |
| Series statement | Chapman & Hall/CRC Biostatistics Series |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc | Includes bibliographical references and index. |
| 505 00 - FORMATTED CONTENTS NOTE | |
| Title | 1. Introduction -- [Ohad Amit] -- 2. Statistical Considerations in Phase I Oncology Trials -- [Simon Wandel and Satrajit Roychoudhury] -- 3. ExposureResponse Analysis in Oncology Trials -- [Yi-Lin Chiu and Balakrishna S. Hosmane] -- 4. Statistical Measures of Interaction for Evaluating a Predictive -- Biomarker -- [Jaya Satgopan] -- 5. Design Considerations for Phase II Oncology Clinical Trials -- [Jared C. Foster, Jennifer Le-Rademacher, and Sumithra J. Mandrekar] -- 6. Precision Medicine and Associated Challenges -- [Rajesh Talluri and Sanjay S. Shete] -- 7. Use of Adaptive Design in Late-Stage Oncology Trials -- [Satrajit Roychoudhury, Arunava Chakravartty, and Pabak Mukhopadhyay] -- 8. Safety Monitoring and Analysis in Oncology Trials -- [Anastasia Ivanova, Qi Jiang, Olga Marchenko, and Richard C. Zink] -- 9. Quality of Life -- [Diane Fairclough] -- 10. Impact of Evolving Regulatory Pathways on Statistical -- Considerations in Oncology Clinical Trials -- [Rajeshwari Sridhara]. |
| 520 3# - SUMMARY, ETC. | |
| Summary, etc | Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and analysis of modern oncology trials. The authors include many relevant real life examples from the pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. The book covers all aspects of cancer clinical trial starting from early phase development. The early part of the book covers novel phase I dose escalation design, exposure response analysis, and innovative phase II design. This includes early development strategy for cancer immunotherapy trials. The contributors also emphasized the role of biomarker and modern era of precision medicine. The second part focuses on the late stage development. This includes the application of adaptive design, safety analysis, and quality of life (QoL) data analysis. The final part discusses current regulatory perspective and challenges. Features: Covers a wide spectrum of topics related to real-life statistical challenges in oncology clinical trials. Provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis. Detailed case studies illustrate the real life applications. Satrajit Roychoudhury is a Senior Director and a member of the Statistical Research and Innovation group in Pfizer Inc. Prior to joining; he was a member of Statistical Methodology and consulting group in Novartis. He has 11 years of extensive experience in working with different phases of clinical trial. His area of research includes early phase oncology trials, survival analysis, model informed drug development, and use of Bayesian methods in clinical trials. He is industry co-chair for the ASA Biopharmaceutical Section Regulatory-Industry Workshop and has provided statistical training in major conferences including the Joint Statistical Meetings, ASA Biopharmaceutical Section Regulatory-Industry Workshop, and ICSA Applied Statistics Symposium. Soumi Lahiri has 12 years of extensive experience in working different therapeutic areas. She is the former Director of Biostatistics in Clinical Oncology, GlaxoSmithKline. She has also worked in the oncology division of Novartis Pharmaceutical Company for two years. She is an active member of the ASA Biopharmaceutical section and former chair of the membership committee. |
| 530 ## - ADDITIONAL PHYSICAL FORM AVAILABLE NOTE | |
| Additional physical form available note | Also available in print format. |
| 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 | MEDICAL / Pharmacology. |
| Source of heading or term | bisacsh |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Antineoplastic agents |
| General subdivision | Development. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Cancer |
| General subdivision | Chemotherapy. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drugs |
| General subdivision | Testing. |
| 655 #0 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Roychoudhury, Satrajit, |
| Relator term | editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Lahiri, Soumi, |
| Relator term | editor. |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | Taylor and Francis. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Display text | Print version: |
| International Standard Book Number | 9781498772693 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | Chapman & Hall/CRC Biostatistics Series. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | https://www.taylorfrancis.com/books/9781315154435 |
| Public note | Click here to view |
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