Oncology Clinical Trials

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Oncology Clinical Trials


Oncology Clinical Trials
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Oncology Clinical Trials


Oncology Clinical Trials
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Author : William Kevin Kelly
language : en
Publisher: Demos Medical Publishing
Release Date : 2018

Oncology Clinical Trials written by William Kevin Kelly and has been published by Demos Medical Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018 with Medical categories.


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

Oncology Clinical Trials


Oncology Clinical Trials
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Author : Susan Halabi, PhD
language : en
Publisher: Demos Medical Publishing
Release Date : 2009-12-22

Oncology Clinical Trials written by Susan Halabi, PhD and has been published by Demos Medical Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-12-22 with Medical categories.


Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout

Clinical Trials In Oncology Third Edition


Clinical Trials In Oncology Third Edition
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Author : Stephanie Green
language : en
Publisher: CRC Press
Release Date : 2012-05-09

Clinical Trials In Oncology Third Edition written by Stephanie Green and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-09 with Mathematics categories.


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.

Textbook Of Clinical Trials In Oncology


Textbook Of Clinical Trials In Oncology
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Author : Susan Halabi
language : en
Publisher: CRC Press
Release Date : 2019-04-24

Textbook Of Clinical Trials In Oncology written by Susan Halabi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-24 with Medical categories.


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

Taking Part In Cancer Treatment Research Studies


Taking Part In Cancer Treatment Research Studies
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Author : National Cancer Institute
language : en
Publisher: Government Printing Office
Release Date : 2018-07-18

Taking Part In Cancer Treatment Research Studies written by National Cancer Institute and has been published by Government Printing Office this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-07-18 with Health & Fitness categories.


Taking Part in Cancer Treatment Research Studies is a booklet for people with cancer who are interested in learning about clinical trials, which are research studies that involve people. The booklet explains how your rights are protected, the benefits and risks of taking part in a clinical trial, questions for you to think about and discuss with your doctor, and how to find a trial you may be eligible for. Related products: Caring for the Caregiver: Support for Cancer Caregivers – ePub format only – ISBN: 9780160947520 Children with Cancer: A Guide for Parents -- ePub format only -- ISBN: 9780160947537 Coping with Advanced Cancer: Support for People with Cancer -- ePub format only ISBN: 9780160947544 Eating Hints: Before, during and after Cancer Treatment -- ePub format only --ISBN: 9780160947551 Life After Cancer Treatment: Facing Forward -- ePub format only -- ISBN: 9780160947568 Pain Control: Support for People with Cancer -- ePub format only -- ISBN: 9780160947575 Radiation Therapy and You: Support for People with Cancer --ePub format only -- ISBN: 9780160947582 Surgery Choice for Women with DCIS and Breast Cancer -- ePub format only -- ISBN: 9780160947599 Understanding Breast Changes: A Health Guide for Women --ePub format only -- ISBN: 9780160947612 Understanding Cervical Changes: A Health Guide for Women -- ePub format only -- ISBN: 9780160947629 When Cancer Returns: Support for People with Cancer -- ePub format only -- ISBN: 9780160947636 When Someone You Love Has Advanced Cancer: Support for Caregivers --ePub format only -- ISBN: 9780160947643 When Someone You Love Has Completed Cancer Treatment: Facing Forward --ePub format only -- ISBN: 9780160947650 When Someone You Love Is Being Treated for Cancer: Support for Caregivers --ePub format only -- ISBN: 9780160947667 When Your Brother or Sister Has Cancer: A Guide for Teens --ePub format only -- ISBN: 9780160947674 When Your Parent Has Cancer: A Guide for Teens -- ePub format only -- ISBN: 9780160947681

Dose Finding Designs For Early Phase Cancer Clinical Trials


Dose Finding Designs For Early Phase Cancer Clinical Trials
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Author : Takashi Daimon
language : en
Publisher: Springer
Release Date : 2019-05-21

Dose Finding Designs For Early Phase Cancer Clinical Trials written by Takashi Daimon and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-05-21 with Medical categories.


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.

Cancer Clinical Trials


Cancer Clinical Trials
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Author : Stephen L. George
language : en
Publisher: CRC Press
Release Date : 2016-08-19

Cancer Clinical Trials written by Stephen L. George and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-19 with Mathematics categories.


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.