Principles and Practice of Clinical Trials, Piantadosi
Автор: Lawrence M. Friedman; Curt D. Furberg; David L. De Название: Fundamentals of Clinical Trials ISBN: 3319307738 ISBN-13(EAN): 9783319307732 Издательство: Springer Рейтинг: Цена: 6986.00 р. Наличие на складе: Поставка под заказ.
Описание: This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful.
Автор: Pawlik Название: Clinical Trials ISBN: 3030354873 ISBN-13(EAN): 9783030354879 Издательство: Springer Рейтинг: Цена: 9083.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.
Автор: Chin, Richard Название: Adaptive and Flexible Clinical Trials ISBN: 0367382474 ISBN-13(EAN): 9780367382476 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in web-based real-time data entry and advances in statistical methods have made adaptive clinical trials much more popular because they have become both more practical and attractive. However, there is paucity of resources that explain the mathematical framework and the practical considerations for adaptive designs without the use of highly technical statistical jargon.
Suitable for readers in academia, industry, and government involved in drug development, Adaptive and Flexible Clinical Trials is the first book that comprehensively explains all essential aspects of adaptive clinical trials. Written in an easy-to-understand style aimed at clinicians and other non-statisticians, this book focuses not on the statistical details, but rather on the application of statistical concepts for adaptive clinical trials. Utilizing concrete examples, the book thoroughly explains the design, conduct, and analysis of adaptive and flexible clinical trials, allowing readers to select and design the appropriate trial designs from a conceptual perspective. From basic theory to real-life practical issues, it covers all aspects of adaptive and flexible clinical trials, including regulatory issues, interim analysis, adaptive dosing, and sequential designs.
Описание: All clinical investigators, sponsors, and Institutional Review Boards have to comply with the applicable FDA code(s). Good Clinical Practice (GCP) Audit Preparation provides a step-by-step explanation of the FDA audit procedures for clinical trials and how a pharmaceutical company should prepare for regulatory audits.
Автор: Chow, Shein-Chung Название: Adaptive Design Methods in Clinical Trials ISBN: 1439839875 ISBN-13(EAN): 9781439839874 Издательство: Taylor&Francis Рейтинг: Цена: 22202.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Brody, Tom (consultant For Second Genome, Inc. (crohn`s Disease), Rigel Pharmaceuticals (platelet Disorder), Primegen Biotech (stem Cell Therapy), Reg Название: Clinical trials ISBN: 0128042176 ISBN-13(EAN): 9780128042175 Издательство: Elsevier Science Рейтинг: Цена: 13304.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Zhen Chen; Aiyi Liu; Yongming Qu; Larry Tang; Nait Название: Applied Statistics in Biomedicine and Clinical Trials Design ISBN: 3319126938 ISBN-13(EAN): 9783319126937 Издательство: Springer Рейтинг: Цена: 26552.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The peer-reviewed contributions were solicited and selected from some 400 presentations at the annual meeting of the International Chinese Statistical Association (ICSA), held with the International Society for Biopharmaceutical Statistics (ISBS).
Автор: Shadreck Mwale Название: Healthy Volunteers in Commercial Clinical Drug Trials ISBN: 3319592130 ISBN-13(EAN): 9783319592138 Издательство: Springer Рейтинг: Цена: 7685.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides a richly detailed contribution to the understanding of healthy volunteer experiences in clinical drug trials in the UK.
Автор: Mallinckrodt, Craig Molenberghs, Geert Lipkovich, Ilya (quintiles, Durham, North Carolina, Usa) Ratitch, Bohdana (eli Lilly Cananda, Ontario, Canada) Название: Estimands, estimators and sensitivity analysis in clinical trials ISBN: 1138592501 ISBN-13(EAN): 9781138592506 Издательство: Taylor&Francis Рейтинг: Цена: 17609.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book will use the new guidance as a framework for developing and implementing comprehensive analysis plans for clinical trials that support the development and approval of medical interventions.
Автор: Ton J. Cleophas; Aeilko H. Zwinderman Название: Efficacy Analysis in Clinical Trials an Update ISBN: 3030199177 ISBN-13(EAN): 9783030199173 Издательство: Springer Рейтинг: Цена: 9781.00 р. Наличие на складе: Поставка под заказ.
Описание: Machine learning and big data is hot. It is, however, virtually unused in clinical trials. This is so, because randomization is applied to even out multiple variablesModern medical computer files often involve hundreds of variables like genes and other laboratory values, and computationally intensive methods are requiredThis is the first publication of clinical trials that have been systematically analyzed with machine learning. In addition, all of the machine learning analyses were tested against traditional analyses. Step by step statistics for self-assessments are includedThe authors conclude, that machine learning is often more informative, and provides better sensitivities of testing than traditional analytic methods do
Автор: Christine S. Walsh Название: Clinical Trials in Ovarian Cancer ISBN: 081358647X ISBN-13(EAN): 9780813586472 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 18810.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: When a patient is diagnosed with a gynecological malignancy, she and her doctors must make urgent, high-risk decisions about her course of treatment. In selecting an appropriate plan of care, physicians must weigh the patient's individual needs, the tumor's specific characteristics, and the treatment's potential side effects. Because there is no one-size-fits-all treatment solution, a plethora of clinical trials have been performed on ovarian cancer patients, but clinicians may struggle to keep up with this ever-growing body of research. Collecting and synthesizing research findings from a wide array of medical journal articles and book chapters, Clinical Trials in Ovarian Cancer provides physicians with an invaluable resource. Gynecologic oncologist Christine S. Walsh systematically outlines each of the seminal Phase III trials that have shaped the treatment of ovarian cancers, detailing the rationale for the trial, the patient population studied, treatment delivery methods, efficacy, toxicity, and trial conclusions. She provides a clear overview of established treatments, as well as still-controversial experimental approaches. The first book to organize this cutting-edge research into an easy-to-use reference, Clinical Trials in Ovarian Cancer should help medical personnel at all levels provide their patients with the highest standard of care.
Автор: Takashi Daimon; Akihiro Hirakawa; Shigeyuki Matsui Название: An Introduction to Dose-Finding Methods in Early Phase Clinical Trials ISBN: 4431555846 ISBN-13(EAN): 9784431555841 Издательство: Springer Рейтинг: Цена: 6986.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: 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.
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