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

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.

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. Already acclaimed in previous editions as a key source of reference for all working in the field of Oncology, the third edition of this text has now been completely revised with important new chapters and illustrations throughout to keep it at the forefront of cancer medicine. Short Contents

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

The Oxford Textbook of Clinical Research Ethics is the first systematic and comprehensive reference on clinical research ethics. Under the editorship of experts from the National Institutes of Health of the United States, the book offers a wide-ranging and systematic examination of all aspects of research with human beings. Considering historical triumphs of research as well as tragedies, the textbook provides a framework for analysing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the textbook examines issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent as well as 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 with human beings.

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 *

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

This textbook combines essential information on clinical cancer medicine with a guide to the latest advances in molecular oncology and tumor biology. Providing a systematic overview of all types of solid tumors, including epidemiology and cancer prevention, genetic aspects of hereditary cancers, differential diagnosis, typical signs and symptoms, diagnostic strategies and staging, and treatment modalities, it also discusses new and innovative cancer treatments, particularly targeted therapy and immunotherapy. Expert commentaries at the end of each chapter highlight key points, offer insights, suggest further reading and discuss clinical application using case descriptions. This textbook is an invaluable, practice-oriented tool for medical students just beginning their clinical oncology studies, as well as for medical oncology residents and young professionals.

In the last few years the use of medical imaging has increased exponentially in routine clinical practice. This has been reflected in a rapidly increasing use of medical imaging in clinical trials, through all phases. More recently this has culminated in a number of inter-disciplinary meetings with the various stake holders, including the FDA. Changes in the regulatory process has resulted, when it comes to the submission of data to the FDA, in a therapeutic agent where one or more of the trial end-points is the assessment of a radiological end-point. No longer is it sufficient to have the images read by the local investigator site. The FDA has also identified Medical Imaging as one of the key 6 points in the Critical Path initiative which was launched in 2004. This puts a keen focus on the role of imaging and the need to clearly identify and understand this aspect of clinical trials. As the pharmaceutical, biotech and medical device industry continues to identify ways to improve and speed up product development, medical imaging plays a more significant role. An understanding of the methodology and the metrics is therefore required but difficult to ascertain in one easy to read volume for individuals entering this field. This book will therefore fulfill this void, be it for the pharmaceutical personnel from medical director to monitor, or the Principal Investigator who is having to understand the complexities of the imaging and why it is having to be sent off-site for a 'central read.'

Walter and Miller’s Textbook of Radiotherapy is a key textbook for therapeutic radiography students as well as trainee clinical and medical oncologists, clinical physicists and technologists. The book is divided into 2 sections. The first section covers physics and provides a comprehensive review of radiotherapy physics. This section is designed to be non-physicist friendly, to simply and clearly explain the physical principles upon which radiotherapy and its technology are based. The second section is a systematic review by tumour site giving an up to date summary of radiotherapy practice. The title also covers the place of chemotherapy, surgery and non-radiotherapy treatments as well as the principles of cancer patient treatment including supportive care and palliative treatments. It is a comprehensive must-have resource for anyone studying therapeutic radiotherapy. Highly illustrated in full colour including 350 photographs. Clearly and simply explains the fundamental physics for clinicians Gives an up to date summary of radiotherapy practice organised by tumour site making it very easy to navigate. Describes the wide range of devices and clearly explains the principles behind their operation. Comprehensively explains the calculation models of dose predictions for treatment preparation. Heavy emphasis on how clinical trials have influenced current practice. Shows how radiobiological knowledge has influenced current practice such as the fractionation regimens for breast and prostate cancer Proton therapy; machines, dose measurement, covering the clinical advantages and pitfalls of this treatment modality. New radiotherapy modalities such as stereotactic radiotherapy, types of intensity modulated radiotherapy and imaged guided radiotherapy are comprehensively covered as are recent advances in chemotherapy and molecular targeted therapy. In depth coverage of dose measurement and new devices.