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    Clinical Trials in Oncology (Chapman & Hall/CRC Interdisciplinary Statistics) (Hardback) By (author) John Crowley, By (author) Stephanie Green, By (author) Jacqueline Benedetti, By (author) Angela Smith

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    DescriptionThe third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.


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    Title
    Clinical Trials in Oncology
    Authors and contributors
    By (author) John Crowley, By (author) Stephanie Green, By (author) Jacqueline Benedetti, By (author) Angela Smith
    Physical properties
    Format: Hardback
    Number of pages: 264
    Width: 156 mm
    Height: 235 mm
    Thickness: 23 mm
    Weight: 589 g
    Language
    English
    ISBN
    ISBN 13: 9781439814482
    ISBN 10: 1439814481
    Classifications

    BIC E4L: HEA
    Nielsen BookScan Product Class 3: S6.1T
    B&T Book Type: NF
    Ingram Subject Code: PI
    Libri: I-PI
    B&T Modifier: Region of Publication: 01
    BIC subject category V2: MJCL
    B&T Merchandise Category: SCI
    B&T General Subject: 710
    B&T Modifier: Academic Level: 03
    Warengruppen-Systematik des deutschen Buchhandels: 16280
    BISAC V2.8: MAT029000, MED062000
    DC22: 616.99
    BISAC V2.8: MED090000
    LC subject heading:
    BISAC V2.8: MED106000
    LC subject heading:
    BIC subject category V2: MBGR1
    LC subject heading: ,
    DC23: 616.994027
    LC classification: RC267 .G744 2012
    DC22: 362.19699/400724
    Edition
    3, Revised
    Edition statement
    3rd Revised edition
    Illustrations note
    59 black & white illustrations, 28 black & white tables
    Publisher
    Taylor & Francis Inc
    Imprint name
    CRC Press Inc
    Publication date
    12 June 2012
    Publication City/Country
    Bosa Roca
    Review quote
    Praise for the Previous Editions "The dedication of the authors to enhancing the quality of clinical trials in oncology is evident from this book. ... This book will be useful to students, clinical research nurses and medical statisticians involved in oncology trials. ... I also recommend it to libraries and clinical institutions." -Clinical Trials, 2004 "With over 60 years combined experience, the authors are ideally positioned to discuss the various statistical issues apparent in clinical trials, identifying alternative solutions, providing logical arguments for and against the various solutions. This book is also recommended for statisticians actively involved in the design, conduct, and analysis of clinical trial data (not only cancer clinical trials)." -Journal of Biopharmaceutical Statistics "A concise, easily readable, and thorough summary...ALL medical oncology, radiation oncology, surgical oncology, and clinical research nurse academic training programs should provide this important text to trainees on Day 1." -Charles R. Thomas Jr., MD, University of Texas Health Science Center at San Antonio, USA "Succinct and focused...[This book] is clear, cogent, and practical. It is structured so that statisticians can use specific sections as starting point to develop shared understandings with investigators, study coordinators, and data managers...It has been useful to me and my clients, and I look forward to the second edition." -Marlene Egger, University of Utah, USA
    Table of contents
    Introduction A Brief History of Clinical Trials The Southwest Oncology Group (SWOG) The Reason for This Book Statistical Concepts Introduction The Single-Arm Phase II Trial-Estimation The Randomized Phase III Trial-Hypothesis Testing The Proportional Hazards Model Sample Size Calculations Concluding Remarks The Design of Clinical Trials Objectives Eligibility Treatment Arms Randomized Treatment Assignment Endpoints Differences to be Detected or Precision of Estimates and Other Assumptions Use of Independent Data Monitoring Committees Ethical Considerations Conclusion Phase I and Phase I/II Trials Phase I Trials Phase I/II Designs Phase II Trials Single-Arm Phase II Designs Multi-Arm Phase II Trials Other Phase II Designs Randomized versus Single-Arm: The Pros and Cons Conclusion Phase III Trials Randomization Other Design Considerations Equivalence or Noninferiority Trials Designs for Targeted Agents Multi-Arm Trials Interim Analyses Phase II/III Trials Concluding Remark Data Management and Quality Control Introduction: Why Worry? Protocol Development Data Collection Data Submission Data Evaluation Publication Quality Assurance Audits Training Database Management Conclusion Reporting of Results Timing of Report Required Information Analyses Conclusion Pitfalls Introduction Historical Controls Competing Risks Outcome by Outcome Analyses Subset Analyses Surrogate Endpoints Exploratory Analyses Introduction Some Background and Notation Identification of Prognostic Factors Forming Prognostic Groups Analysis of Microarray Data Meta-Analysis Concluding Remarks Summary and Conclusions References Index