Success Probability Estimation With Applications To Clinical Trials
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Success Probability Estimation With Applications To Clinical Trials
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Author : Daniele De Martini
language : en
Publisher: John Wiley & Sons
Release Date : 2013-05-06
Success Probability Estimation With Applications To Clinical Trials written by Daniele De Martini 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 2013-05-06 with Medical categories.
Provides an introduction to the various statistical techniques involved in medical research and drug development with a focus on estimating the success probability of an experiment Success Probability Estimation with Applications to Clinical Trials details the use of success probability estimation in both the planning and analyzing of clinical trials and in widely used statistical tests. Devoted to both statisticians and non-statisticians who are involved in clinical trials, Part I of the book presents new concepts related to success probability estimation and their usefulness in clinical trials, and each section begins with a non-technical explanation of the presented concepts. Part II delves deeper into the techniques for success probability estimation and features applications to both reproducibility probability estimation and conservative sample size estimation. Success Probability Estimation with Applications to Clinical Trials: • Addresses the theoretical and practical aspects of the topic and introduces new and promising techniques in the statistical and pharmaceutical industries Features practical solutions for problems that are often encountered in clinical trials Includes success probability estimation for widely used statistical tests, such as parametric and nonparametric models Focuses on experimental planning, specifically the sample size of clinical trials using phase II results and data for planning phase III trials Introduces statistical concepts related to success probability estimation and their usefulness in clinical trials Success Probability Estimation with Applications to Clinical Trials is an ideal reference for statisticians and biostatisticians in the pharmaceutical industry as well as researchers and practitioners in medical centers who are actively involved in health policy, clinical research, and the design and evaluation of clinical trials.
Group Sequential Methods With Applications To Clinical Trials
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Author : Christopher Jennison
language : en
Publisher: CRC Press
Release Date : 1999-09-15
Group Sequential Methods With Applications To Clinical Trials written by Christopher Jennison and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-09-15 with Mathematics categories.
Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion. Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models. Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.
Bayesian Methods In Pharmaceutical Research
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Author : Emmanuel Lesaffre
language : en
Publisher: CRC Press
Release Date : 2020-04-15
Bayesian Methods In Pharmaceutical Research written by Emmanuel Lesaffre and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-15 with Medical categories.
Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients. This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients. The book covers: Theory, methods, applications, and computing Bayesian biostatistics for clinical innovative designs Adding value with Real World Evidence Opportunities for rare, orphan diseases, and pediatric development Applied Bayesian biostatistics in manufacturing Decision making and Portfolio management Regulatory perspective and public health policies Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research.
Randomization In Clinical Trials
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Author : William F. Rosenberger
language : en
Publisher: John Wiley & Sons
Release Date : 2004-03-24
Randomization In Clinical Trials written by William F. Rosenberger 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 2004-03-24 with Mathematics categories.
A unique overview that melds the concepts of conditionalprobability and stochastic processes into real-lifeapplications The role of randomization techniques in clinical trials has becomeincreasingly important. This comprehensive guide combines both theapplied aspects of randomization in clinical trials with aprobabilistic treatment of properties of randomization. Taking anunabashedly non-Bayesian and nonparametric approach to inference,the book focuses on the linear rank test under a randomizationmodel, with added discussion on likelihood-based inference as itrelates to sufficiency and ancillarity. Developments in stochasticprocesses and applied probability are also given where appropriate.Intuition is stressed over mathematics, but not without a cleardevelopment of the latter in the context of the former. Providing a consolidated review of the field, the book includesrelevant and practical discussions of: * The benefits of randomization in terms of reduction of bias * Randomization as a basis for inference * Covariate-adaptive and response-adaptive randomization * Current philosophies, controversies, and new developments With ample problem sets, theoretical exercises, and short computersimulations using SAS, Randomization in Clinical Trials: Theory andPractice is equally useful as a standard textbook in biostatisticsgraduate programs as well as a reliable reference forbiostatisticians in practice.
Clinical Trials Handbook
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Author : Shayne Cox Gad
language : en
Publisher: John Wiley & Sons
Release Date : 2009-06-17
Clinical Trials Handbook written by Shayne Cox Gad 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 2009-06-17 with Science categories.
Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
New Developments In Statistical Modeling Inference And Application
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Author : Zhezhen Jin
language : en
Publisher: Springer
Release Date : 2016-10-28
New Developments In Statistical Modeling Inference And Application written by Zhezhen Jin and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-10-28 with Medical categories.
The papers in this volume represent the most timely and advanced contributions to the 2014 Joint Applied Statistics Symposium of the International Chinese Statistical Association (ICSA) and the Korean International Statistical Society (KISS), held in Portland, Oregon. The contributions cover new developments in statistical modeling and clinical research: including model development, model checking, and innovative clinical trial design and analysis. Each paper was peer-reviewed by at least two referees and also by an editor. The conference was attended by over 400 participants from academia, industry, and government agencies around the world, including from North America, Asia, and Europe. It offered 3 keynote speeches, 7 short courses, 76 parallel scientific sessions, student paper sessions, and social events.
Practical Applications Of Bayesian Reliability
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Author : Yan Liu
language : en
Publisher: John Wiley & Sons
Release Date : 2019-03-18
Practical Applications Of Bayesian Reliability written by Yan Liu 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 2019-03-18 with Technology & Engineering categories.
Demonstrates how to solve reliability problems using practical applications of Bayesian models This self-contained reference provides fundamental knowledge of Bayesian reliability and utilizes numerous examples to show how Bayesian models can solve real life reliability problems. It teaches engineers and scientists exactly what Bayesian analysis is, what its benefits are, and how they can apply the methods to solve their own problems. To help readers get started quickly, the book presents many Bayesian models that use JAGS and which require fewer than 10 lines of command. It also offers a number of short R scripts consisting of simple functions to help them become familiar with R coding. Practical Applications of Bayesian Reliability starts by introducing basic concepts of reliability engineering, including random variables, discrete and continuous probability distributions, hazard function, and censored data. Basic concepts of Bayesian statistics, models, reasons, and theory are presented in the following chapter. Coverage of Bayesian computation, Metropolis-Hastings algorithm, and Gibbs Sampling comes next. The book then goes on to teach the concepts of design capability and design for reliability; introduce Bayesian models for estimating system reliability; discuss Bayesian Hierarchical Models and their applications; present linear and logistic regression models in Bayesian Perspective; and more. Provides a step-by-step approach for developing advanced reliability models to solve complex problems, and does not require in-depth understanding of statistical methodology Educates managers on the potential of Bayesian reliability models and associated impact Introduces commonly used predictive reliability models and advanced Bayesian models based on real life applications Includes practical guidelines to construct Bayesian reliability models along with computer codes for all of the case studies JAGS and R codes are provided on an accompanying website to enable practitioners to easily copy them and tailor them to their own applications Practical Applications of Bayesian Reliability is a helpful book for industry practitioners such as reliability engineers, mechanical engineers, electrical engineers, product engineers, system engineers, and materials scientists whose work includes predicting design or product performance.
Exploring Medical Statistics Biostatistics Clinical Trials And Epidemiology
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Author : Arora, Geeta
language : en
Publisher: IGI Global
Release Date : 2024-07-18
Exploring Medical Statistics Biostatistics Clinical Trials And Epidemiology written by Arora, Geeta and has been published by IGI Global this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-07-18 with Medical categories.
In today's data-driven world, understanding and interpreting statistical information is more critical than ever, especially in medicine, where statistical methods are used to design and analyze clinical trials, study the distribution of disease in populations, and develop new treatments. In the era of evidence-based medicine, Exploring Medical Statistics: Biostatistics, Clinical Trials, and Epidemiology addresses the critical need for a grasp of statistical concepts. This book delves into biostatistics, clinical trials, and epidemiology, offering a robust foundation for understanding and interpreting statistical information in medicine. It explores biostatistics, elucidating fundamental elements such as probability, sampling, and hypothesis testing. The section on clinical trials covers the entire spectrum from trial design to ethical considerations, providing an invaluable resource for researchers navigating the complexities of medical research. Epidemiology, a cornerstone of public health, is examined in the book, offering insights into the distribution and determinants of diseases in populations. The application-focused section further extends the utility of medical statistics, encompassing public health, healthcare policy, and drug development.
Clinical Trial Modernization
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Author : Harry Yang
language : en
Publisher: CRC Press
Release Date : 2025-05-26
Clinical Trial Modernization written by Harry Yang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-05-26 with Mathematics categories.
As the pharmaceutical industry navigates this new era of technological innovation, the integration of AI, big data, and advanced analytics into clinical trials holds immense potential to transform drug development. Clinical Trial Modernization: Technological, Operational, and Regulatory Advances provides a comprehensive overview of the current trends, challenges, and opportunities in modernizing clinical trials, offering a roadmap for stakeholders in this evolving field. This book serves as a valuable resource for professionals, researchers, and regulators, providing actionable insights into the future of clinical trials and their critical role in bringing new therapies to market faster and more effectively.
Biopharmaceutical Applied Statistics Symposium
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Author : Karl E. Peace
language : en
Publisher: Springer
Release Date : 2018-09-03
Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-03 with Medical categories.
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 third of the 3-volume book series. The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine – Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development, Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and OtherData Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.