A Practical Guide to Managing Clinical Trials, Pfeiffer, JoAnn , Wells, Cris
Автор: Pfeiffer Название: A Practical Guide To Managing Clini ISBN: 1138196509 ISBN-13(EAN): 9781138196506 Издательство: Taylor&Francis Рейтинг: Цена: 14545.00 р. Наличие на складе: Нет в наличии.
Описание:
A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application.
Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Описание: This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection or a selection of a pre-specified sub-population. Essentially, this adaptive methodology was introduced in the 1990s. Since then, it has become popular and the object of intense discussion and still represents a rapidly growing field of statistical research. This book describes adaptive design methodology at an elementary level, while also considering designing and planning issues as well as methods for analyzing an adaptively planned trial. This includes estimation methods and methods for the determination of an overall p-value. Part I of the book provides the group sequential methods that are necessary for understanding and applying the adaptive design methodology supplied in Parts II and III of the book. The book contains many examples that illustrate use of the methods for practical application. The book is primarily written for applied statisticians from academia and industry who are interested in confirmatory adaptive designs. It is assumed that readers are familiar with the basic principles of descriptive statistics, parameter estimation and statistical testing. This book will also be suitable for an advanced statistical course for applied statisticians or clinicians with a sound statistical background.
Название: Modern Adaptive Randomized Clinical Trials ISBN: 1482239884 ISBN-13(EAN): 9781482239881 Издательство: Taylor&Francis Рейтинг: Цена: 24499.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Is adaptive randomization always better than traditional fixed-schedule randomization? Which procedures should be used and under which circumstances? What special considerations are required for adaptive randomized trials? What kind of statistical inference should be used to achieve valid and unbiased treatment comparisons following adaptive randomization designs? Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects answers these questions and more. From novel designs to cutting-edge applications, this book presents several new and key developments in adaptive randomization. It also offers a fresh and critical look at a number of already-classical topics. Featuring contributions from statisticians, clinical trialists, and subject-matter experts in academia and the pharmaceutical industry, the text: Clarifies the taxonomy of the concept of adaptive randomization Discusses restricted, covariate-adaptive, response-adaptive, and covariate-adjusted response-adaptive (CARA) randomization designs, as well as randomized designs with treatment selection Gives an exposition to many novel adaptive randomization techniques such as brick tunnel randomization, targeted least absolute shrinkage and selection operator (LASSO)-based CARA randomization, multi-arm multi-stage (MAMS) designs, to name a few Addresses the issues of statistical inference following covariate-adaptive and response-adaptive randomization designs Describes a successful implementation of a single pivotal phase II/III adaptive trial in infants with proliferating hemangioma Explores some practical aspects of phase II dose-ranging studies and examines statistical monitoring and interim analysis issues in response-adaptive randomized clinical trials Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects covers a wide spectrum of topics related to adaptive randomization designs in contemporary clinical trials. The book provides a thorough exploration of the merits of adaptive randomization and aids in identifying when it is appropriate to apply such designs in practice.
Автор: Prokscha Название: Writing And Managing Sops For Gcp ISBN: 1482239353 ISBN-13(EAN): 9781482239355 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book discusses managing SOPs for GCP from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user`s point of view to keep topics focused on the practical aspects of SOPs and SOP management.
Автор: Key Название: Practical Hemostasis and Thrombosis 3e ISBN: 1118344715 ISBN-13(EAN): 9781118344712 Издательство: Wiley Рейтинг: Цена: 15357.00 р. Наличие на складе: Поставка под заказ.
Описание: Designed as a practical, succinct guide, for quick reference by clinicians with everyday questions, this title guides the reader through the range of approaches available for diagnosis, management, or prevention of hemorrhagic and thrombotic diseases or disorders.
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