Textbook of Clinical Trials in Oncology

Textbook of Clinical Trials in Oncology

Author: Susan Halabi

Publisher: CRC Press

ISBN: 9781351620963

Category: Medical

Page: 701

View: 872

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

Textbook of Clinical Trials

Textbook of Clinical Trials

Author: David Machin

Publisher: John Wiley & Sons

ISBN: 9780470010150

Category: Mathematics

Page: 784

View: 589

Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: "... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas." BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.

Oncology Clinical Trials

Oncology Clinical Trials

Author: William Kevin Kelly

Publisher: Demos Medical Publishing

ISBN: 0826168728

Category: Medical

Page: 600

View: 881

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

Clinical Trials in Oncology

Author: Stephanie Green

Publisher: CRC Press

ISBN: 1138199117

Category:

Page: 264

View: 414

The third edition of the bestselling Clinical Trials in Oncologyprovides 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.

Textbook of Clinical Trials in Oncology

Textbook of Clinical Trials in Oncology

Author: Susan Halabi

Publisher: CRC Press

ISBN: 9781351620970

Category: Medical

Page: 626

View: 154

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

Dose-Finding Designs for Early-Phase Cancer Clinical Trials

Dose-Finding Designs for Early-Phase Cancer Clinical Trials

Author: Takashi Daimon

Publisher: Springer

ISBN: 9784431555858

Category: Medical

Page: 133

View: 113

This book provides a comprehensive introduction to statistical methods for designing early phase dose-finding clinical trials. It will serve as a textbook or handbook for graduate students and practitioners in biostatistics and clinical investigators who are involved in designing, conducting, monitoring, and analyzing dose-finding trials. The book will also provide an overview of advanced topics and discussions in this field for the benefit of researchers in biostatistics and statistical science. Beginning with backgrounds and fundamental notions on dose finding in early phase clinical trials, the book then provides traditional and recent dose-finding designs of phase I trials for, e.g., cytotoxic agents in oncology, to evaluate toxicity outcome. Included are rule-based and model-based designs, such as 3 + 3 designs, accelerated titration designs, toxicity probability interval designs, continual reassessment method and related designs, and escalation overdose control designs. This book also covers more complex and updated dose-finding designs of phase I-II and I/II trials for cytotoxic agents, and cytostatic agents, focusing on both toxicity and efficacy outcomes, such as designs with covariates and drug combinations, maximum tolerated dose-schedule finding designs, and so on.

Oxford Textbook of Oncology

Oxford Textbook of Oncology

Author: David J. Kerr

Publisher: Oxford University Press

ISBN: 9780199656103

Category: Medical

Page: 1041

View: 810

This textbook provides current information on best practice in multidisciplinary cancer care. Divided into six sections, the contributors look at the aetiology of cancer, patient care, population health and thethe management of specific types of disease. Written and edited by internationally recognised leaders in the field, the new edition of the Oxford Textbook of Oncology has been fully revised and updated, taking into consideration the advancements in each of the major therapeutic areas, and representing the multidisciplinary management of cancer. Structured in six sections, the book provides an accessible scientific basis to the key topics of oncology, examining how cancer cells grow and function, as well as discussing the aetiology of cancer, and the general principles governing modern approaches to oncology treatment. The book examines the challenges presented by the treatment of cancer on a larger scale within population groups, and the importance of recognising and supporting the needs of individual patients, both during and after treatment. A series of disease-oriented, case-based chapters, ranging from acute leukaemia to colon cancer, highlight the various approaches available for managing the cancer patient, including the translational application of cancer science in order to personalise treatment. The advice imparted in these cases has relevance worldwide, and reflects a modern approach to cancer care. The Oxford Textbook of Oncology provides a comprehensive account of the multiple aspects of best practice in the discipline, making it an indispensable resource for oncologists of all grades and subspecialty interests. Review: Each chapter is nicely illustrated with schemes, cartoons and images. The text, although written by top oncologists, is readily understandable for a non-expert. Thus, the textbook will no doubt be appreciated by a broader audience. * Recent Patents on Anti-Cancer Drug Discovery Vol. 11 Issue No. 4, Alexander Shtil * I recommend this book highly to all oncology and oncologists in training as a thorough, informative, and readable reference. Every large intuitional library and every oncology library should have it. * NEJM, 2002 * This comprehensive textbook of oncology is the first new major textbook on cancer to appear in a decade and is designed for a broad audience of clinicians, oncologists in training, and academics. The coverage is comprehensive...The overall appearance of the book is outstanding. It is a welcome combination of epidemiology, aspects of basic science, pharmacology and radiation therapy that trainees will fine a nice change...should enjoy a wide readership...because of its appealing design and comprehensive approach to oncology. It is the most user-friendly comprehensive text currently available. The pathology, basic science, epidemiology, and radiation therapy sections are all presented with extreme clarity. * Doody's Journal , 2002 * A landmark reference...It sets new standards for publishing in oncology offering a ground-breaking innovative approach to the filed combined with the quality, accuracy , and intellectual rigour you have come to expect from the world's most prestigious reference publisher. * Biomedicine and Pharmacotherapy, 2002 * Under new editorship, the second edition is far more than an updated version of the first...the prose in the Oxford Textbook is exemplary...this textbook is unique among its peers in giving the sense that the authors are addressing the reader personally...an exception level of quality...Respect for the evidence-based medicine is apparent throughout the text...illustrative and anatomical drawing...of remarkable high quality...excellent discussion of doctor-patient communication in relation OT genetic counselling, psychological issues, and terminal cancers. * JAMA, Volume 287, Issue 24, 2002 * The Oxford Textbook of Oncology covers virtually the entire spectrum of malignant diseases in adults and children. It meets very high editorial and production standards: the organization, illustrations, and eye-pleasing typography are outstanding... I have high praise for this textbook. * NEJM, Volume 347, Number 2, 2002 * Review from previous edition The Oxford Textbook of Oncology is a classic and fresh approach to the field. It is a must for all libraries and all those who like to have a single up-to-date reference book that contains sufficient detail for the clinician in all subspecialties: surgery and chapters are sufficiently details to provide a reference for trainees in the field. * Oncology, Volume 63, 2002 * The Oxford Textbook of Oncology is what it is meant to be: a textbook with comprehensive information of the actual status of oncology... an indispensable and attractive source of information. * Professor Jaak Ph. Janssens, European Journal of Cancer Prevention * This volume provides a comprehensive account of the multiple aspects of best practice in the discipline, making it an indispensable resource for oncologists of all grades and subspecialty interests. * Anticancer Research Vol. 36 (2016) * An outstanding gift to the international scientific community... The new textbook is an excellent demonstration of this multifaceted and astonishingly variable problem, as well as of the latest achievements in its understanding and practical management. * Alexander A. Shtil, Recent Patents on Anticancer Drug Discovery * I would recommend anyone considering buying an oncology textbook, and particularly those who work in oncology support services, to consider this textbook as it is well set out, easy to read, easy to comprehend, and covers all of the important aspects of modern day oncology. * Dr Andrew Davies, Consultant in Palliative Medicine, Royal Surrey County Hospital; Review for Supportive Care in Cancer *

Textbook of Medical Oncology

Textbook of Medical Oncology

Author: Stan B. Kaye`

Publisher: CRC Press

ISBN: 185317825X

Category: Medical

Page: 804

View: 152

Effective care of the cancer patient increasingly involves systemic treatment, and as the range of available therapeutic agents continues to expand, the medical oncologist must be fully aware of the combinations. This new edition provides a practical overview of the many treatment choices, and has been fully updated, including discussion of new classification systems, anticancer agents and treatment protocols.

The Oxford Textbook of Clinical Research Ethics

The Oxford Textbook of Clinical Research Ethics

Author: Ezekiel J. Emanuel

Publisher: OUP USA

ISBN: 9780199768639

Category: Medical

Page: 848

View: 642

The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.

Textbook of Medical Oncology

Textbook of Medical Oncology

Author: Franco Cavalli

Publisher: CRC Press

ISBN: 9780203092897

Category: Medical

Page: 476

View: 922

Effective care of the cancer patient increasingly involves systemic treatment, and as the range of available therapeutic agents continues to expand, the medical oncologist must be fully aware of the rationale for choosing specific drugs and combinations. Textbook of Medical Oncology, 4th edition, is written by a highly acclaimed list of internation

Handbook of Statistics in Clinical Oncology, Third Edition

Handbook of Statistics in Clinical Oncology, Third Edition

Author: John Crowley

Publisher: CRC Press

ISBN: 9781439862001

Category: Mathematics

Page: 661

View: 648

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.

Methods and Biostatistics in Oncology

Methods and Biostatistics in Oncology

Author: Raphael. L.C Araújo

Publisher: Springer

ISBN: 9783319713243

Category: Medical

Page: 348

View: 582

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.