A Practical Guide To Designing Phase Ii Trials In Oncology
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A Practical Guide To Designing Phase Ii Trials In Oncology
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Author : Sarah R. Brown
language : en
Publisher: John Wiley & Sons
Release Date : 2014-05-12
A Practical Guide To Designing Phase Ii Trials In Oncology written by Sarah R. Brown and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-05-12 with Medical categories.
How to identify optimal phase II trial designs Providing a practical guide containing the information needed to make crucial decisions regarding phase II trial designs, A Practical Guide to Designing Phase II Trials in Oncology sets forth specific points for consideration between the statistician and clinician when designing a phase II trial, including issues such as how the treatment works, choice of outcome measure and randomization, and considering both academic and industry perspectives. A comprehensive and systematic library of available phase II trial designs is included, saving time otherwise spent considering multiple manuscripts, and real-life practical examples of using this approach to design phase II trials in cancer are given. A Practical Guide to Designing Phase II Trials in Oncology: Offers a structured and practical approach to phase II trial design Considers trial design from both an academic and industry perspective Includes a structured library of available phase II trial designs Is relevant to both clinical and statistical researchers at all levels Includes real life examples of applying this approach For those new to trial design, A Practical Guide to Designing Phase II Trials in Oncology will be a unique and practical learning tool, providing an introduction to the concepts behind informed decision making in phase II trials. For more experienced practitioners, the book will offer an overview of new, less familiar approaches to phase II trial design, providing alternative options to those which they may have previously used.
Phase I Cancer Clinical Trials
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Author : Elizabeth A. Eisenhauer
language : en
Publisher: Oxford University Press
Release Date : 2015-03-20
Phase I Cancer Clinical Trials written by Elizabeth A. Eisenhauer and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-03-20 with Medical categories.
Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. Their primary goals are to identify the recommended dose, schedule and pharmacologic behavior of new agents or new combinations of agents and to describe the adverse effects of treatment. In cancer therapeutics, such studies have particular challenges. Due to the nature of the effects of treatment, most such studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Further, the endpoints of these trials are usually measures adverse effects rather than molecular target or anti-tumor effects. These factors render the design, conduct, analysis and ethical aspects of phase I cancer trials unique. As the only comprehensive book on this topic, Phase I Cancer Clinical Trials is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials
An Introduction To Statistics In Early Phase Trials
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Author : Steven Julious
language : en
Publisher: John Wiley & Sons
Release Date : 2010-01-19
An Introduction To Statistics In Early Phase Trials written by Steven Julious and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-01-19 with Medical categories.
All new medicines and devices undergo early phase trials to assess, interpret and better understand their efficacy, tolerability and safety. An Introduction to Statistics in Early Phase Trials describes the practical design and analysis of these important early phase clinical trials and provides the crucial statistical basis for their interpretation. It clearly and concisely provides an overview of the most common types of trials undertaken in early phase clinical research and explains the different methodologies used. The impact of statistical technologies on clinical development and the statistical and methodological basis for making clinical and investment decisions are also explained. Conveys key ideas in a concise manner understandable by non-statisticians Explains how to optimise designs in a constrained or fixed resource setting Discusses decision making criteria at the end of Phase II trials Highlights practical day-to-day issues and reporting of early phase trials An Introduction to Statistics in Early Phase Trials is an essential guide for all researchers working in early phase clinical trial development, from clinical pharmacologists and pharmacokineticists through to clinical investigators and medical statisticians. It is also a valuable reference for teachers and students of pharmaceutical medicine learning about the design and analysis of clinical trials.
Methods And Biostatistics In Oncology
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Author : Raphael. L.C Araújo
language : en
Publisher: Springer
Release Date : 2018-04-16
Methods And Biostatistics In Oncology written by Raphael. L.C Araújo and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-04-16 with Medical categories.
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.
An Introduction To Clinical Trials
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Author : Jonathan A. Cook
language : en
Publisher: Oxford University Press
Release Date : 2023-05-17
An Introduction To Clinical Trials written by Jonathan A. Cook and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-05-17 with Medical categories.
An Introduction to clinical trials is a concise step-by-step guide to the principles and practices of clinical trials for those studying clinical trials or new to working on one. Clinical trials are critical to the progress of medicine and improving healthcare, as they evaluate whether new treatments and interventions work. They are also complex, multidisciplinary projects that integrate science, ethics, and legal requirements in the conduct of medical research. Starting with the research question, An Introduction to clinical trials explains study design, sample size determination, study set-up, study conduct, statistical analysis, and dissemination of the results. The book primarily focusses on randomised controlled trials as the "ultimate" clinical trial. It demystifies the terminology used in clinical trials research and presents the underlying scientific and statistical concepts. Real-life examples are used throughout to bring concepts to life. Written by an experienced medical statistician, An Introduction to clinical trials will benefit readers of all backgrounds, from postgraduate and medical students, trainee doctors and healthcare professionals to others working on clinical trials in a professional capacity. This book aims to help readers gain a fuller and more rounded understanding of clinical trials.
Crossover Designs
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Author : Kung-Jong Lui
language : en
Publisher: John Wiley & Sons
Release Date : 2016-08-08
Crossover Designs written by Kung-Jong Lui and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-08 with Medical categories.
A comprehensive and practical resource for analyses of crossover designs For ethical reasons, it is vital to keep the number of patients in a clinical trial as low as possible. As evidenced by extensive research publications, crossover design can be a useful and powerful tool to reduce the number of patients needed for a parallel group design in studying treatments for non-curable chronic diseases. This book introduces commonly-used and well-established statistical tests and estimators in epidemiology that can easily be applied to hypothesis testing and estimation of the relative treatment effect for various types of data scale in crossover designs. Models with distribution-free random effects are assumed and hence most approaches considered here are semi-parametric. The book provides clinicians and biostatisticians with the exact test procedures and exact interval estimators, which are applicable even when the number of patients in a crossover trial is small. Systematic discussion on sample size determination is also included, which will be a valuable resource for researchers involved in crossover trial design. Key features: Provides exact test procedures and interval estimators, which are especially of use in small-sample cases. Presents most test procedures and interval estimators in closed-forms, enabling readers to calculate them by use of a pocket calculator or commonly-used statistical packages. Each chapter is self-contained, allowing the book to be used a reference resource. Uses real-life examples to illustrate the practical use of test procedures and estimators Provides extensive exercises to help readers appreciate the underlying theory, learn other relevant test procedures and understand how to calculate the required sample size. Crossover Designs: Testing, Estimation and Sample Size will be a useful resource for researchers from biostatistics, as well as pharmaceutical and clinical sciences. It can also be used as a textbook or reference for graduate students studying clinical experiments.
The Design Of Studies For Medical Research
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Author : David Machin
language : en
Publisher: John Wiley & Sons
Release Date : 2005-05-13
The Design Of Studies For Medical Research written by David Machin and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-05-13 with Medical categories.
The same careful rigour imposed on the design of phase III randomised controlled trials is not always applied to medical research in other areas such as trials conducted at earlier stages of drug development. With the emphasis that is now placed on evidence-based medicine, such care and rigour will inevitably impact on these areas with increasing attention turned to the quality of design. This title describes what principles can be used to structure research effectively allowing for the required degree of accuracy. Written by two best selling authors, this book includes many examples from medical literature and will be of great value to all groups conducting studies at the interface of clinical and laboratory research.
Sample Size Tables For Clinical Studies
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Author : David Machin
language : en
Publisher: John Wiley & Sons
Release Date : 2011-08-26
Sample Size Tables For Clinical Studies written by David Machin and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-08-26 with Medical categories.
This book provides statisticians and researchers with the statistical tools - equations, formulae and numerical tables - to design and plan clinical studies and carry out accurate, reliable and reproducible analysis of the data so obtained. There is no way around this as incorrect procedure in clinical studies means that the researcher's paper will not be accepted by a peer-reviewed journal. Planning and analysing clinical studies is a very complicated business and this book provides indispensible factual information. Please go to http://booksupport.wiley.com and enter 9781405146500 to easily download the supporting materials.
A Concise Guide To Clinical Trials
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Author : Allan Hackshaw
language : en
Publisher: John Wiley & Sons
Release Date : 2024-07-01
A Concise Guide To Clinical Trials written by Allan Hackshaw and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-07-01 with Medical categories.
Design and execute life-saving trials with this accessible resource Clinical trials have revolutionized the treatment of disease and the development of life-saving pharmaceuticals. They contribute decisively to diagnosis, the avoidance of early death, medical intervention and are central to the modern work of pharmaceutical producers. The design and execution of clinical trials is one of the fastest-growing and most important areas of medical and pharmaceutical research. A Concise Guide to Clinical Trials provides an accessible and comprehensive survey of clinical trials, their design, and their applications. Beginning with a taxonomy of trial types, the book overviews stages of analysis, ethical and legal requirements, and more. Now fully updated to reflect the latest research and clinical practice, it continues to be an indispensable resource for researchers and clinicians. Readers of the second edition of A Concise Guide to Clinical Trials will also find: New material on pharmaceutical trials, adaptive designs, and the use of “big data” The easy-to-use organization facilitates both first-time learning and reference Detailed treatment of concepts such as health technology assessments (HTA), patient and public involvement and engagement (PPIE), and more A Concise Guide to Clinical Trials is ideal for clinicians and healthcare professionals looking for a working knowledge of clinical trials, as well as for pharmaceutical workers and regulators looking to understand this vital aspect of the industry.
Textbook Of Gastrointestinal Oncology
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Author : Suayib Yalcin
language : en
Publisher: Springer Nature
Release Date : 2019-09-05
Textbook Of Gastrointestinal Oncology written by Suayib Yalcin and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-09-05 with Medical categories.
This textbook discusses core principles and practices in gastrointestinal oncology and covers a wide range of practice areas such as pathology and radiologic images, epidemiology, genetics, staging, multidisciplinary management of specific gastrointestinal cancer, and pathology for each primary tumor site. The comprehensive coverage makes Textbook of Gastrointestinal Oncology a useful resource for the practitioner wishing to gain a greater understanding of the principles of managing malignant gastrointestinal disease, as well as medical oncology fellows, surgeons, radiation oncologists, gastroenterologists and fellows, and residents.