Design and Analysis of Clinical Trials - Concepts and Methodologies, Third Edition, Chow
Автор: Schulz Kenneth Название: Essential Concepts in Clinical Research ISBN: 0702073946 ISBN-13(EAN): 9780702073946 Издательство: Elsevier Science Рейтинг: Цена: 6230.00 р. Наличие на складе: Нет в наличии.
Описание:
This practical guide speaks to two audiences: those who read and those who conduct research. Clinicians are medical detectives by training. For each patient, they assemble clinical clues to establish causes of signs and symptoms. The task involves both clinical acumen and knowledge of medical research. This book helps guide clinicians through this detective work, by enabling them to make sense of research and to review medical literature critically. It will also be invaluable to researchers who conduct clinical research, particularly randomized controlled trials.
Building on previously published, peer-reviewed articles from The Lancet, this handbook is essential for busy clinicians and active researchers interested in research methods.
Written by leaders in the field of clinical research who have published extensively with authorship of hundreds of articles in medical journals.
The authorship includes one of the three authors of the CONSORT guidelines for the reporting of randomized controlled trials.
The book presents the essential concepts to a wide array of topics including randomized control trials, descriptive studies, cohort studies, case-control studies, bias, and screening tests.
The book utilises a readable and humorous prose style, lightening what can be a difficult area for clinical readers.
Derived from decades of teaching clinical research in seminar settings the book will empower clinicians to make sense of, and critically appraise, current medical research and will enable researchers to enrich the quality of their work.
For this Second Edition, the authors have revised and updated the original 16 chapters and added six new chapters. For busy clinicians and active researchers interested in research methods, this book provides helpful tools to derive satisfaction - indeed, fun - from clinical science.
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.
Описание: This book provides practical knowledge to biomedical researchers using biological and biochemical specimen in order to understand health and disease processes at cellular, clinical, and population levels. Concepts and techniques provided will help researchers design and conduct studies, then translate data from bench to clinics.
Описание: Provides a presentation of the design, monitoring, analysis, and interpretation of clinical trials in which time-to-event is of critical interest. This book discusses the design and monitoring of Phase II and III clinical trials with time-to-event endpoints.
Автор: Chang, Mark Название: Monte Carlo Simulation for the Pharmaceutical Industry ISBN: 1138374385 ISBN-13(EAN): 9781138374386 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Helping you become a creative, logical thinker and skillful simulator, Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies provides broad coverage of the entire drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and methods needed to carry out computer simulations efficiently, covers both descriptive and pseudocode algorithms that provide the basis for implementation of the simulation methods, and illustrates real-world problems through case studies.
The text first emphasizes the importance of analogy and simulation using examples from a variety of areas, before introducing general sampling methods and the different stages of drug development. It then focuses on simulation approaches based on game theory and the Markov decision process, simulations in classical and adaptive trials, and various challenges in clinical trial management and execution. The author goes on to cover prescription drug marketing strategies and brand planning, molecular design and simulation, computational systems biology and biological pathway simulation with Petri nets, and physiologically based pharmacokinetic modeling and pharmacodynamic models. The final chapter explores Monte Carlo computing techniques for statistical inference.
This book offers a systematic treatment of computer simulation in drug development. It not only deals with the principles and methods of Monte Carlo simulation, but also the applications in drug development, such as statistical trial monitoring, prescription drug marketing, and molecular docking.
Описание: Presents a range of solutions to analytic issues. This title reflects developments in methodology with coverage of mixture models and a dataset example. It implements examples using SAS and R code and incorporates a number of examples from real QoL clinical trials to illustrate design and analysis methods.
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: Matsui Shigeyuki Название: Design and Analysis of Clinical Trials for Predictive Medicine ISBN: 1466558156 ISBN-13(EAN): 9781466558151 Издательство: Taylor&Francis Рейтинг: Цена: 17609.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics--from identifying molecular biomarkers using DNA microarrays to confirming their clinical utility in randomized clinical trials.
The foundation of modern clinical trials was laid many years before modern developments in biotechnology and genomics. Drug development in many diseases is now shifting to molecularly targeted treatment. Confronted with such a major break in the evolution toward personalized or predictive medicine, the methodologies for design and analysis of clinical trials is now evolving.
This book is one of the first attempts to contribute to this evolution by laying a foundation for the use of appropriate statistical designs and methods in future clinical trials for predictive medicine. It is a useful resource for clinical biostatisticians, researchers focusing on predictive medicine, clinical investigators, translational scientists, and graduate biostatistics students.
Название: Cancer Clinical Trials ISBN: 1498706886 ISBN-13(EAN): 9781498706889 Издательство: Taylor&Francis Рейтинг: Цена: 14086.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
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.
Автор: Peace Название: Biopharmaceutical Applied Statistics Symposium ISBN: 9811078254 ISBN-13(EAN): 9789811078255 Издательство: Springer Рейтинг: Цена: 15372.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: On Statistical Approaches to 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.- Some 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.- 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.- Multiplicity Problems in Clinical Trials - A Regulatory Perspective.
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