Handbook Of Statistics In Clinical Oncology Third Edition

Author: John Crowley
Editor: CRC Press
ISBN: 1439862001
Size: 12,36 MB
Format: PDF, ePub, Docs
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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.

Oncology Clinical Trials

Author: William Kevin Kelly, DO
Editor: Springer Publishing Company
ISBN: 0826168736
Size: 17,71 MB
Format: PDF, ePub
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The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all regulatory aspects in the pursuit of global oncology trials Digital access to the ebook included

Clinical Trials In Oncology Third Edition

Author: Stephanie Green
Editor: CRC Press
ISBN: 1439814481
Size: 10,41 MB
Format: PDF, Mobi
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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.

Clinical Trials In Oncology Second Edition

Author: Stephanie Green
Editor: CRC Press
ISBN: 1420035304
Size: 17,63 MB
Format: PDF
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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 Board Review Second Edition

Author: Francis P. Worden, MD
Editor: Springer Publishing Company
ISBN: 1617052922
Size: 10,95 MB
Format: PDF
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Print version of the book includes free access to the app (web, iOS, and Android), which offers interactive Q&A review plus the entire text of the print book! Please note the app is included with print purchase only. Oncology Board Review: Blueprint Study Guide and Q&A is a concise, outline-based study guide covering the topics that appear on the Medical Oncology Certification Exam. This second edition has been thoroughly revised to include new treatment regimens, clinical guidelines, and other updates impacting the field and reflected on the test. The book includes all topics listed in the American Board of Internal Medicine (ABIM) blueprint as essential material for the Medical Oncology Certification Exam. The coverage spans all hematologic malignancies and solid tumors, beginning with the epidemiology, and followed by the etiology and risk factors of the disease, staging, signs and symptoms, diagnostic criteria, indications for treatment, prognostic factors, treatment recommendations, and special considerations. Later chapters review other major subspecialty areas found on the exam including cancer genetics and tumor biology, supportive and palliative care, bone marrow transplantation, and biostatistics. Each chapter includes key points summarized in digestible bullets for easy recall and self-assessment. And, now containing over 230 board style questions with answers and detailed rationales, Oncology Board Review, Second Edition is the go-to, quick review for any trainee preparing for initial certification and for oncologists preparing for recertification. New to this Edition: Includes over 230 board style questions and answers with rationales New chapter on Bone Marrow Transplantation Thoroughly updated and revised chapters with all new treatment recommendations and FDA approvals for solid tumors and hematologic malignancies included.

Sample Size Calculations In Clinical Research

Author: Shein-Chung Chow
Editor: CRC Press
ISBN: 0824748239
Size: 13,70 MB
Format: PDF
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Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical research and development, Sample Size Calculation in Clinical Research explores the causes of discrepancies and how to avoid them. This volume provides formulas and procedures for determination of sample size required not only for testing equality, but also for testing non-inferiority/superiority, and equivalence (similarity) based on both untransformed (raw) data and log-transformed data under a parallel-group design or a crossover design with equal or unequal ratio of treatment allocations. It contains a comprehensive and unified presentation of statistical procedures for sample size calculation that are commonly employed at various phases of clinical development. Each chapter includes, whenever possible, real examples of clinical studies from therapeutic areas such as cardiovascular, central nervous system, anti-infective, oncology, and women's health to demonstrate the clinical and statistical concepts, interpretations, and their relationships and interactions. The book highlights statistical procedures for sample size calculation and justification that are commonly employed in clinical research and development. It provides clear, illustrated explanations of how the derived formulas and/or statistical procedures can be used.

Practical Clinical Oncology

Author: Louise Hanna
Editor: Cambridge University Press
ISBN: 1107683629
Size: 19,82 MB
Format: PDF
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A complete guide to clinical oncology, covering the main treatment modalities and diagnosis and treatment strategies for specific tumour types.

Comprehensive Geriatric Oncology Second Edition

Author: Lodovico Balducci
Editor: CRC Press
ISBN: 1841842966
Size: 15,81 MB
Format: PDF
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The prevention and treatment of cancer in older patients requires an individualized approach, as age causes unpredictable results from patient to patient. Completely revised and updated, the Second Edition of Comprehensive Geriatric Oncology enables clinicians to choose the best possible cancer care. Highlighting newly emerging issues in geriatric oncology, it helps physicians promote cancer prevention. Like its groundbreaking, bestselling predecessor, this new edition exhaustively reviews the biology of cancer and aging, epidemiologic trends, and clinical trials that concern cancer prevention and treatment in the elderly. New chapters contain material on topics such as assessment, fragility, symptom management, and emergencies, and studies the effectiveness of training programs in geriatric oncology. The book addresses issues of healthcare delivery, including cost and evaluation of utility and outcome, suggests new research approaches, reviews existing guidelines for the prevention and treatment of cancer in the elderly, and more. Providing a frame of reference for the ongoing dialogue in the field of geriatric oncology, this is a major reference work for basic, population, and clinical scientists interested in the issue and for practices ministering to older patients.

Introduction To Statistical Methods For Clinical Trials

Author: Thomas D. Cook
Editor: CRC Press
ISBN: 1584880279
Size: 20,26 MB
Format: PDF, ePub, Mobi
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Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.

Bayesian Adaptive Methods For Clinical Trials

Author: Scott M. Berry
Editor: CRC Press
ISBN: 9781439825518
Size: 20,72 MB
Format: PDF, ePub, Mobi
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Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer’s disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adaptive Methods for Clinical Trials explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. The book first summarizes the current state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative. It then gives an overview of basic Bayesian methodological and computational tools needed for Bayesian clinical trials. With a focus on Bayesian designs that achieve good power and Type I error, the next chapters present Bayesian tools useful in early (Phase I) and middle (Phase II) clinical trials as well as two recent Bayesian adaptive Phase II studies: the BATTLE and ISPY-2 trials. In the following chapter on late (Phase III) studies, the authors emphasize modern adaptive methods and seamless Phase II–III trials for maximizing information usage and minimizing trial duration. They also describe a case study of a recently approved medical device to treat atrial fibrillation. The concluding chapter covers key special topics, such as the proper use of historical data, equivalence studies, and subgroup analysis. For readers involved in clinical trials research, this book significantly updates and expands their statistical toolkits. The authors provide many detailed examples drawing on real data sets. The R and WinBUGS codes used throughout are available on supporting websites. Scott Berry talks about the book on the CRC Press YouTube Channel.