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Principles and Practice of Clinical Trials, Piantadosi


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Автор: Piantadosi
Название:  Principles and Practice of Clinical Trials
ISBN: 9783319526355
Издательство: Springer
Классификация:


ISBN-10: 3319526359
Обложка/Формат: Hardback
Страницы: 2604
Вес: 5.47 кг.
Дата издания: 04.08.2022
Серия: Principles and practice of clinical trials
Язык: English
Издание: 1st ed. 2022
Иллюстрации: 148 tables, color; 153 illustrations, color; 88 illustrations, black and white; lv, 2604 p. 241 illus., 153 illus. in color. in 3 volumes, not availab
Размер: 224 x 329 x 216
Читательская аудитория: General (us: trade)
Основная тема: Statistics
Ссылка на Издательство: Link
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Поставляется из: Германии
Описание: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
Дополнительное описание: Landmark Trials. - Procurement and Distributionof Study Medicines. - Budget Development. - Responsibilities and Management of the Coordinating Center. - Mechanics of Masking Investigators. - Dose Finding for Drug Combinations. - Adaptive Phase 2 Designs.


Bayesian Approaches to Clinical Trials and Health-Care Evaluation

Автор: David J. Spiegelhalter
Название: Bayesian Approaches to Clinical Trials and Health-Care Evaluation
ISBN: 0471499757 ISBN-13(EAN): 9780471499756
Издательство: Wiley
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Цена: 70700.00 T
Наличие на складе: Заказано в издательстве.
Описание: READ ALL ABOUT IT! David Spiegelhalter has recently joined the ranks of Isaac Newton, Charles Darwin and Stephen Hawking by becoming a fellow of the Royal Society. Originating from the Medical Research Council`s biostatistics unit, David has played a leading role in the Bristol heart surgery and Harold Shipman inquiries.

Simulation For Designing Clinical Trials: A Pharmacokinetic-Pharmacodynamic Modeling Perspective

Автор: Kimko Hui
Название: Simulation For Designing Clinical Trials: A Pharmacokinetic-Pharmacodynamic Modeling Perspective
ISBN: 0824708628 ISBN-13(EAN): 9780824708627
Издательство: Taylor&Francis
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Цена: 183750.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation practices. The book discusses how to design clinical trials according to their probability for success, techniques to define distributions of virtual subjects' characteristics, methods to determine the sensitivity of the trial design, and the population relationship between dosing schedules and patient response.

Statistics Applied to Clinical Trials

Автор: Ton J. Cleophas; Aeilko H. Zwinderman; Toine F. Cl
Название: Statistics Applied to Clinical Trials
ISBN: 1402095228 ISBN-13(EAN): 9781402095221
Издательство: Springer
Рейтинг:
Цена: 69830.00 T
Наличие на складе: Поставка под заказ.
Описание: Explains classical statistical analysis of clinical trials. This book addresses relatively novel issues, including equivalence testing, interim analysis, sequential analysis, meta-analysis, and provides a framework of the best statistical methods available for such purpose. It is suitable for investigators in the field of clinical trials.

Biopharmaceutical Applied Statistics Symposium

Автор: Karl E. Peace; Ding-Geng Chen; Sandeep Menon
Название: Biopharmaceutical Applied Statistics Symposium
ISBN: 9811340072 ISBN-13(EAN): 9789811340079
Издательство: Springer
Рейтинг:
Цена: 102480.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:

This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials.  The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter.

The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications.  

This book is the second of the 3-volume book series. The topics covered include: Statistical Approaches to the Meta-analysis of Randomized Clinical Trials, Collaborative Targeted Maximum Likelihood Estimation to Assess Causal Effects in Observational Studies, Generalized Tests in Clinical Trials, Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free , Imputing Missing Data Using a Surrogate Biomarker: Analyzing the Incidence of Endometrial Hyperplasia, Selected Statistical Issues in Patient-reported Outcomes, Network Meta-analysis, Detecting Safety Signals Among Adverse Events in Clinical Trials, Applied Meta-analysis Using R, Treatment of Missing Data in Comparative Effectiveness Research, Causal Estimands: A Common Language for Missing Data, Bayesian Subgroup Analysis with Examples, Statistical Methods in Diagnostic Devices, A Question-Based Approach to the Analysis of Safety Data, Analysis of Two-stage Adaptive Seamless Trial Design, and Multiplicity Problems in Clinical Trials – A Regulatory Perspective.


Statistical Principles of Clinical Trials

Автор: Proschan, Michael A. , Dodd, Lori E.
Название: Statistical Principles of Clinical Trials
ISBN: 1138058564 ISBN-13(EAN): 9781138058569
Издательство: Taylor&Francis
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Цена: 54090.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The authors present the essence of statistical reasoning in clinical trials,peppered with well-known clinical trials This book uses only a small number of important principles to develop the entire statistical foundation of clinical trials in approximately 200-250 pages. Therefore, readers will acquire a formidable statistical armamentarium in a fairly short time. It includes detailed case studies of trials such as the Extracorporeal Membrane Oxygenation trial, the Cardiac Arrhythmia Suppression Trial, and the Women’s Health Initiative.

Statistical design, monitoring, and analysis of clinical trials

Автор: Shih, Weichung Joe (rutgers University School Of Public Health, Piscataway, New Jersey, Usa) Aisner, Joseph (rutgers University Robert Wood Johnson Me
Название: Statistical design, monitoring, and analysis of clinical trials
ISBN: 0367772442 ISBN-13(EAN): 9780367772444
Издательство: Taylor&Francis
Рейтинг:
Цена: 84710.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book concentrates on the biostatistics component of clinical trials. This new, second edition is updated throughout and includes three new chapters. This text reflects the academic research, commercial development, and public health aspects of clinical trials.

Methods and Applications of Statistics in Clinical  Trials, Volume 1 and Volume 2 - Concepts, Principles, Trials, and Designs  Set

Автор: Balakrishnan
Название: Methods and Applications of Statistics in Clinical Trials, Volume 1 and Volume 2 - Concepts, Principles, Trials, and Designs Set
ISBN: 1118790782 ISBN-13(EAN): 9781118790786
Издательство: Wiley
Рейтинг:
Цена: 335750.00 T
Наличие на складе: Поставка под заказ.

Methods and Applications of Statistics in Clinical Trials: Volume 1 - Concepts, Principles, Trials, and Designs

Автор: Balakrishnan
Название: Methods and Applications of Statistics in Clinical Trials: Volume 1 - Concepts, Principles, Trials, and Designs
ISBN: 111830473X ISBN-13(EAN): 9781118304730
Издательство: Wiley
Рейтинг:
Цена: 190030.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This comprehensive book features both new and established material on the key statistical principles and concepts for designing modern-day clinical trials, such as hazard ratio, flexible designs, confounding, covariates, missing data, and longitudinal data.

Fundamentals of Clinical Trials

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: 46570.00 T
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.

Clinical Trials

Автор: Pawlik
Название: Clinical Trials
ISBN: 3030354873 ISBN-13(EAN): 9783030354879
Издательство: Springer
Рейтинг:
Цена: 60550.00 T
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.

Adaptive and Flexible Clinical Trials

Автор: Chin, Richard
Название: Adaptive and Flexible Clinical Trials
ISBN: 0367382474 ISBN-13(EAN): 9780367382476
Издательство: Taylor&Francis
Рейтинг:
Цена: 65320.00 T
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.


Clinical Trials Audit Preparation: A Guide for Good Clinical Practice

Автор: Mihajlovic-Madzarevic, Vera
Название: Clinical Trials Audit Preparation: A Guide for Good Clinical Practice
ISBN: 0470248858 ISBN-13(EAN): 9780470248850
Издательство: Wiley
Рейтинг:
Цена: 97100.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
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.


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