Handbook of Statistics in Clinical Oncology, Third Edition

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Publisher : CRC Press
ISBN 13 : 1439862001
Total Pages : 661 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Handbook of Statistics in Clinical Oncology, Third Edition by : John Crowley

Download or read book Handbook of Statistics in Clinical Oncology, Third Edition written by John Crowley and published by CRC Press. This book was released on 2012-03-26 with total page 661 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been exploding. Inclusion of high-dimensional data and imaging techniques have become common practice, and statistical methods on how to analyse such data have been refined in this area. A compilation of statistical topics relevant to these new advances in cancer research, this third edition of Handbook of Statistics in Clinical Oncology focuses on the design and analysis of oncology clinical trials and translational research. Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials, incorporating updates to all four parts: Phase I trials: Updated recommendations regarding the standard 3 + 3 and continual reassessment approaches, along with new chapters on phase 0 trials and phase I trial design for targeted agents. Phase II trials: Updates to current experience in single-arm and randomized phase II trial designs. New chapters include phase II designs with multiple strata and phase II/III designs. Phase III trials: Many new chapters include interim analyses and early stopping considerations, phase III trial designs for targeted agents and for testing the ability of markers, adaptive trial designs, cure rate survival models, statistical methods of imaging, as well as a thorough review of software for the design and analysis of clinical trials. Exploratory and high-dimensional data analyses: All chapters in this part have been thoroughly updated since the last edition. New chapters address methods for analyzing SNP data and for developing a score based on gene expression data. In addition, chapters on risk calculators and forensic bioinformatics have been added. Accessible to statisticians and oncologists interested in clinical trial methodology, the book is a single-source collection of up-to-date statistical approaches to research in clinical oncology.

Handbook of Statistics in Clinical Oncology

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Author :
Publisher : CRC Press
ISBN 13 : 9780824790257
Total Pages : 566 pages
Book Rating : 4.7/5 (92 download)

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Book Synopsis Handbook of Statistics in Clinical Oncology by : John Crowley

Download or read book Handbook of Statistics in Clinical Oncology written by John Crowley and published by CRC Press. This book was released on 2001-04-27 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book compiles state-of-the-art statistical approaches to solving problems in clinical oncology, focusing on clinical trials in phases I, II, and III, as well as quality of life and economic analyses, and exploratory methods. Examines trial design treatment based on toxicity and survival! Featuring over 1000 references, more than 40 world-renowned contributors, and 300 equations, tables, and drawings, the Handbook of Statistics in Clinical Oncology provides a comprehensive discussion of sample size considers analytical problems generated by controlling treatment costs and maintaining quality of life demonstrates the breadth and depth of current activity in the field of survival analysis sets the limits on what can and cannot be concluded from single and multiple clinical trials and more! The best single source for up-to-date graphical, tree-based, and other statistical methods, the Handbook of Statistics in Clinical Oncology is fascinating reading for oncologists, cancer researchers, biostatisticians, applied statisticians, and medical and graduate students in these disciplines.

Handbook of Statistics in Clinical Oncology, Second Edition

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Author :
Publisher : Chapman and Hall/CRC
ISBN 13 : 9780824723392
Total Pages : 640 pages
Book Rating : 4.7/5 (233 download)

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Book Synopsis Handbook of Statistics in Clinical Oncology, Second Edition by : John Crowley

Download or read book Handbook of Statistics in Clinical Oncology, Second Edition written by John Crowley and published by Chapman and Hall/CRC. This book was released on 2005-12-01 with total page 640 pages. Available in PDF, EPUB and Kindle. Book excerpt: A compendium of cutting-edge statistical approaches to solving problems in clinical oncology, Handbook of Statistics in Clinical Oncology, Second Edition focuses on clinical trials in phases I, II, and III, proteomic and genomic studies, complementary outcomes and exploratory methods. Cancer Forum called the first edition a “1⁄4good reference book for statisticians who will be designing and analyzing cancer trials." The second edition includes over 1000 references, more than forty world-renowned contributors, and 300 equations, tables, and drawings. During the five years since publication of the first edition, there has been an explosion in the technological capabilities supporting genomic and proteomic research, which are is now firmly implanted in clinical oncology. Reflecting these developments, the second edition contains a new section devoted to analyses of high-throughput data and bioinformatics. Previous chapters of the first edition have been revised to reflect current state of the art in their respective domains. The intended audience is primarily statisticians working in cancer and more generally, in any discipline of medicine. But oncologists too will find the material accessible and will benefit from a rudimentary understanding of the fundamental concepts laid forth in each chapter. Completely revised while keeping the features that made the first edition a bestseller, this is the best single source for up-to-date statistical approaches to research in clinical medicine. More than just an update of the handbook that became the gold standard, this second edition brings you fully into the genomic era of medicine.

Handbook of Statistics in Clinical Oncology

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Author :
Publisher : CRC Press
ISBN 13 : 142002776X
Total Pages : 642 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Handbook of Statistics in Clinical Oncology by : John Crowley

Download or read book Handbook of Statistics in Clinical Oncology written by John Crowley and published by CRC Press. This book was released on 2005-12-01 with total page 642 pages. Available in PDF, EPUB and Kindle. Book excerpt: A compendium of cutting-edge statistical approaches to solving problems in clinical oncology, Handbook of Statistics in Clinical Oncology, Second Edition focuses on clinical trials in phases I, II, and III, proteomic and genomic studies, complementary outcomes and exploratory methods. Cancer Forum called the first edition a

Biostatistics for Oncologists

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Publisher : Springer Publishing Company
ISBN 13 : 0826168590
Total Pages : 200 pages
Book Rating : 4.8/5 (261 download)

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Book Synopsis Biostatistics for Oncologists by : Kara-Lynne Leonard, MD, MS

Download or read book Biostatistics for Oncologists written by Kara-Lynne Leonard, MD, MS and published by Springer Publishing Company. This book was released on 2018-04-28 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biostatistics for Oncologists is the first practical guide providing the essential biostatistical concepts, oncology-specific examples, and applicable problem sets for medical oncologists, radiation oncologists, and surgical oncologists. The book also serves as a review for medical oncology and radiation oncology residents or fellows preparing for in-service and board exams. All examples are relevant to oncology and demonstrate how to apply core conceptual knowledge and applicable methods related to hypothesis testing, correlation and regression, categorical data analysis and survival analysis to the field of oncology. The book also provides guidance on the fundamentals of study design and analysis. Written for oncologists by oncologists, this practical text demystifies challenging statistical concepts and provides concise direction on how to interpret, analyze, and critique data in oncology publications, as well as how to apply statistical knowledge to understanding, designing, and analyzing clinical trials. With practical problem sets and twenty-five multiple choice practice questions with answers, the book is an indispensable review for anyone preparing for in-service exams, boards, MOC, or looking to hone a lifelong skill. Key Features: Practically explains biostatistics concepts important for passing the hematology, medical oncology, and radiation oncology boards and MOC exams. Provides guidance on how to read, understand, and critique data in oncology publications. Gives relevant examples that are important for analyzing data in oncology, including the design and analysis of clinical trials. Tests your comprehension of key biostatistical concepts with problem sets at the end of each section and a final section devoted to board-style multiple choice questions and answers Includes digital access to the eBook

Textbook of Clinical Trials in Oncology

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Author :
Publisher : CRC Press
ISBN 13 : 1351620967
Total Pages : 701 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Textbook of Clinical Trials in Oncology by : Susan Halabi

Download or read book Textbook of Clinical Trials in Oncology written by Susan Halabi and published by CRC Press. This book was released on 2019-04-24 with total page 701 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book’s website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others

Methods and Biostatistics in Oncology

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Author :
Publisher : Springer
ISBN 13 : 3319713248
Total Pages : 348 pages
Book Rating : 4.3/5 (197 download)

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Book Synopsis Methods and Biostatistics in Oncology by : Raphael. L.C Araújo

Download or read book Methods and Biostatistics in Oncology written by Raphael. L.C Araújo and published by Springer. This book was released on 2018-04-16 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces and discusses the most important aspects of clinical research methods and biostatistics for oncologists, pursuing a tailor-made and practical approach. Evidence-based medicine (EBM) has been in vogue in the last few decades, particularly in rapidly advancing fields such as oncology. This approach has been used to support decision-making processes worldwide, sparking new clinical research and guidelines on clinical and surgical oncology. Clinical oncology research has many peculiarities, including specific study endpoints, a special focus on survival analyses, and a unique perspective on EBM. However, during medical studies and in general practice, these topics are barely taught. Moreover, even when EBM and clinical cancer research are discussed, they are presented in a theoretical fashion, mostly focused on formulas and numbers, rather than on clinical application for a proper literature appraisal. Addressing that gap, this book discusses more practical aspects of clinical research and biostatistics in oncology, instead of relying only on mathematical formulas and theoretical considerations. Methods and Biostatistics in Oncology will help readers develop the skills they need to understand the use of research on everyday oncology clinical practice for study design and interpretation, as well to demystify the use of EBM in oncology.

Statistical Approaches in Oncology Clinical Development

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Publisher : CRC Press
ISBN 13 : 1351650475
Total Pages : 243 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Statistical Approaches in Oncology Clinical Development by : Satrajit Roychoudhury

Download or read book Statistical Approaches in Oncology Clinical Development written by Satrajit Roychoudhury and published by CRC Press. This book was released on 2018-12-07 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Clinical Trials in Oncology, Third Edition

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Author :
Publisher : CRC Press
ISBN 13 : 1439814481
Total Pages : 266 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Clinical Trials in Oncology, Third Edition by : Stephanie Green

Download or read book Clinical Trials in Oncology, Third Edition written by Stephanie Green and published by CRC Press. This book was released on 2012-05-09 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 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.

Oxford Handbook of Medical Statistics

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Publisher : Oxford University Press
ISBN 13 : 0199551286
Total Pages : 540 pages
Book Rating : 4.1/5 (995 download)

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Book Synopsis Oxford Handbook of Medical Statistics by : Janet Peacock

Download or read book Oxford Handbook of Medical Statistics written by Janet Peacock and published by Oxford University Press. This book was released on 2011 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: The majority of medical research involves quantitative methods and so it is essential to be able to understand and interpret statistics. This book shows readers how to develop the skills required to critically appraise research evidence effectively, and how to conduct research and communicate their findings.

Handbook of Statistics in Clinical Oncology

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Publisher : CRC Press
ISBN 13 : 143986201X
Total Pages : 643 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Handbook of Statistics in Clinical Oncology by : John Crowley

Download or read book Handbook of Statistics in Clinical Oncology written by John Crowley and published by CRC Press. This book was released on 2012-03-26 with total page 643 pages. Available in PDF, EPUB and Kindle. Book excerpt: Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials. Accessible to statisticians in clinical trials as well as oncologists interested in clinical trial methodology, the book presents up-to-date statistical approaches to the design and analysis of oncology clinical trials. New topics in this edition include trial designs for targeted agents, Bayesian trial design, and the inclusion of high-dimensional data and imaging techniques. This edition also contains numerous figures and examples to better explain concepts.

Medical Statistics for Cancer Studies

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Publisher : CRC Press
ISBN 13 : 1000601153
Total Pages : 407 pages
Book Rating : 4.0/5 (6 download)

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Book Synopsis Medical Statistics for Cancer Studies by : Trevor F. Cox

Download or read book Medical Statistics for Cancer Studies written by Trevor F. Cox and published by CRC Press. This book was released on 2022-06-23 with total page 407 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cancer is a dreaded disease. One in two people will be diagnosed with cancer within their lifetime. Medical Statistics for Cancer Studies shows how cancer data can be analysed in a variety of ways, covering cancer clinical trial data, epidemiological data, biological data, and genetic data. It gives some background in cancer biology and genetics, followed by detailed overviews of survival analysis, clinical trials, regression analysis, epidemiology, meta-analysis, biomarkers, and cancer informatics. It includes lots of examples using real data from the author’s many years of experience working in a cancer clinical trials unit. Features: A broad and accessible overview of statistical methods in cancer research Necessary background in cancer biology and genetics Details of statistical methodology with minimal algebra Many examples using real data from cancer clinical trials Appendix giving statistics revision.

Frontiers of Biostatistical Methods and Applications in Clinical Oncology

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Publisher : Springer
ISBN 13 : 981100126X
Total Pages : 438 pages
Book Rating : 4.8/5 (11 download)

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Book Synopsis Frontiers of Biostatistical Methods and Applications in Clinical Oncology by : Shigeyuki Matsui

Download or read book Frontiers of Biostatistical Methods and Applications in Clinical Oncology written by Shigeyuki Matsui and published by Springer. This book was released on 2017-10-03 with total page 438 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents the state of the art of biostatistical methods and their applications in clinical oncology. Many methodologies established today in biostatistics have been brought about through its applications to the design and analysis of oncology clinical studies. This field of oncology, now in the midst of evolution owing to rapid advances in biotechnologies and cancer genomics, is becoming one of the most promising disease fields in the shift toward personalized medicine. Modern developments of diagnosis and therapeutics of cancer have also been continuously fueled by recent progress in establishing the infrastructure for conducting more complex, large-scale clinical trials and observational studies. The field of cancer clinical studies therefore will continue to provide many new statistical challenges that warrant further progress in the methodology and practice of biostatistics. This book provides a systematic coverage of various stages of cancer clinical studies. Topics from modern cancer clinical trials include phase I clinical trials for combination therapies, exploratory phase II trials with multiple endpoints/treatments, and confirmative biomarker-based phase III trials with interim monitoring and adaptation. It also covers important areas of cancer screening, prognostic analysis, and the analysis of large-scale molecular data in the era of big data.

Clinical Trials in Oncology, Second Edition

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Publisher : Chapman and Hall/CRC
ISBN 13 : 9781584883029
Total Pages : 280 pages
Book Rating : 4.8/5 (83 download)

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Book Synopsis Clinical Trials in Oncology, Second Edition by : Stephanie Green

Download or read book Clinical Trials in Oncology, Second Edition written by Stephanie Green and published by Chapman and Hall/CRC. This book was released on 2002-07-30 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: Studies that are unimpeachably thorough, non-political, unbiased, and properly designed... These are the standards to which everyone in clinical research aspires. Yet, the difficulties in designing trials and interpreting data are subtle and ever present. The new edition of Clinical Trials in Oncology provides a concise, nontechnical, and now thoroughly up-to-date review of methods and issues related to clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the major pitfalls that are seemingly inherent in these processes. This edition includes a new section that describes recent innovations in Phase I designs. Another new section on microarray data examines the challenges presented by massive data sets and describes approaches used to meet those challenges. As always, the authors use clear, lucid prose and a multitude of real-world trials as examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Although the book focuses on cancer trials, the issues and concepts are important in any clinical setting. Clinical Trials in Oncology, Second Edition works to improve the mutual understanding by clinicians and statisticians of the principles of clinical trials and helps them avoid the many hazards that can jeopardize the success of a trial.

Oncology Clinical Trials

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Author :
Publisher : Demos Medical Publishing
ISBN 13 : 9781935281764
Total Pages : 168 pages
Book Rating : 4.2/5 (817 download)

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Book Synopsis Oncology Clinical Trials by : Susan Halabi, PhD

Download or read book Oncology Clinical Trials written by Susan Halabi, PhD and published by Demos Medical Publishing. This book was released on 2009-12-22 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout

Clinical Trials in Oncology

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Author :
Publisher : CRC Press
ISBN 13 : 1420035304
Total Pages : 281 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Clinical Trials in Oncology by : Stephanie Green

Download or read book Clinical Trials in Oncology written by Stephanie Green and published by CRC Press. This book was released on 2010-12-12 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: Studies that are unimpeachably thorough, non-political, unbiased, and properly designed These are the standards to which everyone in clinical research aspires. Yet, the difficulties in designing trials and interpreting data are subtle and ever present. The new edition of Clinical Trials in Oncology provides a concise, nontechnical, and now

Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials

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Author :
Publisher : CRC Press
ISBN 13 : 149874611X
Total Pages : 306 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials by : John O'Quigley

Download or read book Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials written by John O'Quigley and published by CRC Press. This book was released on 2017-04-27 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials gives a thorough presentation of state-of-the-art methods for early phase clinical trials. The methodology of clinical trials has advanced greatly over the last 20 years and, arguably, nowhere greater than that of early phase studies. The need to accelerate drug development in a rapidly evolving context of targeted therapies, immunotherapy, combination treatments and complex group structures has provided the stimulus to these advances. Typically, we deal with very small samples, sequential methods that need to be efficient, while, at the same time adhering to ethical principles due to the involvement of human subjects. Statistical inference is difficult since the standard techniques of maximum likelihood do not usually apply as a result of model misspecification and parameter estimates lying on the boundary of the parameter space. Bayesian methods play an important part in overcoming these difficulties, but nonetheless, require special consideration in this particular context. The purpose of this handbook is to provide an expanded summary of the field as it stands and also, through discussion, provide insights into the thinking of leaders in the field as to the potential developments of the years ahead. With this goal in mind we present: An introduction to the field for graduate students and novices A basis for more established researchers from which to build A collection of material for an advanced course in early phase clinical trials A comprehensive guide to available methodology for practicing statisticians on the design and analysis of dose-finding experiments An extensive guide for the multiple comparison and modeling (MCP-Mod) dose-finding approach, adaptive two-stage designs for dose finding, as well as dose–time–response models and multiple testing in the context of confirmatory dose-finding studies. John O’Quigley is a professor of mathematics and research director at the French National Institute for Health and Medical Research based at the Faculty of Mathematics, University Pierre and Marie Curie in Paris, France. He is author of Proportional Hazards Regression and has published extensively in the field of dose finding. Alexia Iasonos is an associate attending biostatistician at the Memorial Sloan Kettering Cancer Center in New York. She has over one hundred publications in the leading statistical and clinical journals on the methodology and design of early phase clinical trials. Dr. Iasonos has wide experience in the actual implementation of model based early phase trials and has given courses in scientific meetings internationally. Björn Bornkamp is a statistical methodologist at Novartis in Basel, Switzerland, researching and implementing dose-finding designs in Phase II clinical trials. He is one of the co-developers of the MCP-Mod methodology for dose finding and main author of the DoseFinding R package. He has published numerous papers on dose finding, nonlinear models and Bayesian statistics, and in 2013 won the Royal Statistical Society award for statistical excellence in the pharmaceutical industry.