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Clinical Trials in Oncology

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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


"This book provides a very clear and concise overview of the main issues in the design, data management, and analysis of clinical trials. Although the examples used are from oncology trials, the principles apply to all clinical trials and so will be of use to a wide audience. The book is well written and easy to read ... recommended reading to anyone involved in the design and running of clinical trials, not just statisticians, although some familiarity with statistical terminology would help. ... a very useful and accessible reference, which covers the essential statistical elements of designing and running clinical trials all in one book, which is extensively illustrated with real examples." -ISCB News, 57, June 2014 Praise for 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

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