Handbook Of Statistics In Clinical Oncology Third Edition

Author: John Crowley
Editor: CRC Press
ISBN: 1439862001
Size: 14,80 MB
Format: PDF
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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: 12,91 MB
Format: PDF, Mobi
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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 Second Edition

Author: Stephanie Green
Editor: CRC Press
ISBN: 1420035304
Size: 14,94 MB
Format: PDF, ePub, Docs
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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.

Comprehensive Geriatric Oncology Second Edition

Author: Lodovico Balducci
Editor: CRC Press
ISBN: 1841842966
Size: 17,85 MB
Format: PDF, ePub
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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: 15,20 MB
Format: PDF, ePub, Docs
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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.

Gynecologic Oncology Handbook

Author: Michelle Benoit, MD
Editor: Springer Publishing Company
ISBN: 1617052965
Size: 10,22 MB
Format: PDF, ePub, Mobi
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Now in its second edition, Gynecologic Oncology Handbook: An Evidence-Based Clinical Guide has been thoroughly updated to include the latest advances in surgical techniques, chemotherapy protocols, AJCC 8th Edition staging criteria, and much more. This current edition contains illustrations that reinforce key concepts, algorithms for diagnostic techniques, and tables to guide you in optimal disease management. The handbook covers the spectrum of gynecologic oncology from seminal studies to guide the oncologist, to the essential workup for the Obstetrician/Gynecologist and related clinician. This handbook can be carried by the practitioner on the ward or in the clinic. It includes necessary details on gynecologic cancer screening and treatment regimens for preinvasive disease, to staging and management of all the gynecologic cancers such as cervical cancer, ovarian cancer, uterine cancer, vulvar cancer, vaginal cancer, and gestational trophoblastic disease. It highlights evidence-based best practices for managing these cancers, hereditary cancer syndromes, for surgical care, and for all adjuvant therapies including chemotherapy, radiation therapy, targeted therapies, and immunotherapies. Detailed sections on survivorship care, palliative care, as well as managing reproductive function and other comorbid medical conditions make this a ‘one-stop shop’ for navigating all clinical aspects and effects of gynecologic cancer. Featuring new and important clinical study references, medical comorbidity algorithms, directed gynecologic cancer workups and treatments, numerous tables and easy-to-reference illustrations, the Gynecologic Oncology Handbook, 2nd Edition is the ultimate quick reference for the clinical management of all gynecologic malignancies and related conditions. Key Features: Covers all fundamentals of gynecologic oncology including workup, staging, surgical management, chemotherapy and radiation therapy treatment, comorbidity diagnosis and management, and background study data Provides Gynecologic Oncology Referral Parameters, Performance Status Scales, Adverse Event Grading, RECIST evaluation criteria, chemotherapy protocols, statistics, and other useful formulas. Includes clinical study references, medical comorbidity algorithms, directed workups, and treatment guidelines

Targeted Therapies In Oncology

Author: Giuseppe Giaccone
Editor: CRC Press
ISBN: 9781420020588
Size: 16,10 MB
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Targeted therapy is one of the most burgeoning areas of development in cancer research. Increasing knowledge in tumor formation and growth at the molecular level has generated a broad array of therapeutic options, including signal transduction inhibition, anti-angiogenic and anti-vascular agents, cell cycle inhibitors, telomerase and telomere interacting agents, apoptosis inducers, and anti-invasive agents. This book presents an authoritative overview of existing molecular targeted therapies, their relevance and role for specific tumors, and their clinical efficacy and impact on patient treatment.

Practical Clinical Oncology

Author: Louise Hanna
Editor: Cambridge University Press
ISBN: 1107683629
Size: 11,50 MB
Format: PDF, Mobi
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A complete guide to clinical oncology, covering the main treatment modalities and diagnosis and treatment strategies for specific tumour types.

Oxford Handbook Of Medical Statistics

Author: Janet Peacock
Editor: Oxford University Press
ISBN: 0199551286
Size: 10,88 MB
Format: PDF
Read: 446
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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.

Sample Size Calculations In Clinical Research Third Edition

Author: Shein-Chung Chow
Editor: CRC Press
ISBN: 1351727117
Size: 17,58 MB
Format: PDF, ePub, Docs
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Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." – Journal of the Royal Statistical Society Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation. Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation. ?