Clinical Trials in Oncology, Third Edition

Clinical Trials in Oncology, Third Edition

Author: Stephanie Green

Publisher: CRC Press

ISBN: 9781439814482

Category: Mathematics

Page: 266

View: 401

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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.

Oncology Clinical Trials

Oncology Clinical Trials

Author: William Kevin Kelly

Publisher: Demos Medical Publishing

ISBN: 0826168728

Category: Medical

Page: 600

View: 533

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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

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: 592

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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

Cancer Clinical Trials

Cancer Clinical Trials

Author: Stephen L. George

Publisher: CRC Press

ISBN: 9781315354330

Category: Mathematics

Page: 384

View: 163

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Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.

Phase I Cancer Clinical Trials

Phase I Cancer Clinical Trials

Author: Elizabeth A. Eisenhauer

Publisher: Oxford University Press, USA

ISBN: 9780199359011

Category: Language Arts & Disciplines

Page: 369

View: 760

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Preceded by Phase I cancer clinical trials: a practical guide / Elizabeth A. Eisenhauer, Christopher Twelves, Marc Buyse. 1st ed. 2006.

Improving the Quality of Cancer Clinical Trials

Improving the Quality of Cancer Clinical Trials

Author: Institute of Medicine

Publisher: National Academies Press

ISBN: 9780309116688

Category: Medical

Page: 136

View: 717

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Scientists and clinicians seek a new paradigm that could improve the efficiency, cost-effectiveness, and overall success rate of cancer clinical trials, while maintaining the highest standards of quality. To explore innovative paradigms for cancer clinical trials and other ways to improve their quality, the National Cancer Policy Forum held a workshop, Improving the Quality of Cancer Clinical Trials, in Washington, DC. The main goals of the workshop were to examine new approaches to clinical trial design and execution that would: (1) better inform decisions and plans of those responsible for developing new cancer therapies (2) more rapidly move new diagnostic tests and treatments toward regulatory approval and use in the clinic (3) be less costly than current trials The resulting workshop summary will serve as input to the deliberations of an Institute of Medicine committee that will develop consensus-based recommendations for moving the field of cancer clinical trials forward.

A National Cancer Clinical Trials System for the 21st Century

A National Cancer Clinical Trials System for the 21st Century

Author: Institute of Medicine

Publisher: National Academies Press

ISBN: 9780309151863

Category: Medical

Page: 316

View: 584

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The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.

Cancer Clinical Trials

Cancer Clinical Trials

Author: National Institutes of Health

Publisher: CreateSpace

ISBN: 1477686983

Category: Medical

Page: 98

View: 772

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The National Institutes of Health Publication 05-5051, Cancer Clinical Trials: The In-Depth Program provides health care professionals and others with a more in-depth understanding of clinical trials. Research supports that the public understands very little about clinical trials. Some people are fearful of being “guinea pigs,” even though participants in clinical trials receive high-quality care. Other people are not aware of clinical trials as an option, do not understand how they work, or do not have access to them. Likewise, health care professionals may be unaware of appropriate clinical trials, may not want to refer people out of their practice, may believe that standard therapy is best, or may think that getting involved in clinical trials will add an undue administrative burden to their work. Today's standard cancer treatments were yesterday's clinical trials. Successful clinical trials have: Increased survival rates of participants with testicular cancer, breast cancer, leukemia, and lymphoma; Decreased morbidity associated with the surgical treatment of many cancers; Resulted in the development of new compounds and techniques to reduce the side effects of cancer therapies. This guide is designed to familiarize health care professionals and others with the ins and outs of clinical trials. It describes how: The clinical trial process works, Trials are designed to obtain particular information, Clinical trials advance standard cancer treatment, Trial participants are safeguarded, People might face obstacles to participating in clinical trials, To find a local clinical trial. After reading the guide and reviewing the case study, the reader will be better able to manage issues related to clinical trials. The reader should be able to: Discuss clinical trials as potential treatment or preventive options, Answer people's questions and allay their fears about clinical trials, Locate and refer people to accessible clinical trials, Ultimately help advance the early detection, treatment, and eventual prevention of cancer.~

Cancer Clinical Trials: Proactive Strategies

Cancer Clinical Trials: Proactive Strategies

Author: Stanley P. L. Leong

Publisher: Springer Science & Business Media

ISBN: 9780387332246

Category: Medical

Page: 326

View: 448

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Clinical trials remain the most important vehicle for improving the care of cancer patients. This text presents the fundamental components and challenges involving clinical investigations. Leading experts discuss the critical issues covering the spectrum of important topics from planning to application. The book has a foreword by Samuel A. Wells, Jr., MD, Professor of Surgery, Duke University Medical Center, Durham, NC, former Director of the American College of Surgeons and Founder of the American College of Surgeons Oncology Group.

Textbook of Clinical Trials

Textbook of Clinical Trials

Author: David Machin

Publisher: John Wiley & Sons

ISBN: 9780470010150

Category: Mathematics

Page: 784

View: 158

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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.

Cancer Clinical Trials

Cancer Clinical Trials

Author: Marc E. Buyse

Publisher: Oxford University Press, USA

ISBN: UCAL:B4106119

Category: Antineoplastic agents

Page: 504

View: 625

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The first complete guide to organizing and running cancer clinical trials, this book brings together in a single volume information on the fundamental concepts of trials, design, planning, conduct, and analysis that has previously ben scattered throughout medical and statistical literature. Topics covered include scientific background, ethical considerations, design and quality control, treatment toxicities and results in solid and non-solid tumors, preclinical and phase I trials, design of phase II trials, and analysis of phase III trials.