Statistical Methods For Dose Finding Experiments

DOWNLOAD

Download Statistical Methods For Dose Finding Experiments PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Statistical Methods For Dose Finding Experiments book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page

Statistical Methods For Dose Finding Experiments

DOWNLOAD
Author : Sylvie Chevret
language : en
Publisher: John Wiley & Sons
Release Date : 2006-05-26

Statistical Methods For Dose Finding Experiments written by Sylvie Chevret 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 2006-05-26 with Mathematics categories.

Dose-finding experiments define the safe dosage of a drug in development, in terms of the quantity given to a patient. Statistical methods play a crucial role in identifying optimal dosage. Used appropriately, these methods provide reliable results and reduce trial duration and costs. In practice, however, dose-finding is often done poorly, with widely used conventional methods frequently being unreliable, leading to inaccurate results. However, there have been many advances in recent years, with new statistical techniques being developed and it is important that these new techniques are utilized correctly. Statistical Methods for Dose-Finding Experiments reviews the main statistical approaches for dose-finding in phase I/II clinical trials and presents practical guidance on their correct use. Includes an introductory section, summarizing the essential concepts in dose-finding. Contains a section on algorithm-based approaches, such as the traditional 3+3 design, and a section on model-based approaches, such as the continual reassessment method. Explains fundamental issues, such as how to stop trials early and how to cope with delayed or ordinal outcomes. Discusses in detail the main websites and software used to implement the methods. Features numerous worked examples making use of real data. Statistical Methods for Dose-Finding Experiments is an important collaboration from the leading experts in the area. Primarily aimed at statisticians and clinicians working in clinical trials and medical research, there is also much to benefit graduate students of biostatistics.

Dose Finding By The Continual Reassessment Method

DOWNLOAD
Author : Ying Kuen Cheung
language : en
Publisher: CRC Press
Release Date : 2011-03-29

Dose Finding By The Continual Reassessment Method written by Ying Kuen Cheung and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-03-29 with Mathematics categories.

This book presents the continual reassessment method (CRM) as a tool for dose-finding studies. With a focus on the implementation and practice of the CRM and its variations, it explains how the CRM may be calibrated and extended to suit common clinical settings. The book includes examples of real clinical trials data to illustrate the calibration techniques and shows how R can be used to carry out the techniques. It reviews the literature, related methodology, and theoretical properties of the CRM. It also explores alternatives for situations where the CRM fails.

Methods And Applications Of Statistics In Clinical Trials Volume 1

DOWNLOAD
Author : Narayanaswamy Balakrishnan
language : en
Publisher: John Wiley & Sons
Release Date : 2014-03-05

Methods And Applications Of Statistics In Clinical Trials Volume 1 written by Narayanaswamy Balakrishnan 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 2014-03-05 with Medical categories.

A complete guide to the key statistical concepts essential for the design and construction of clinical trials As the newest major resource in the field of medical research, Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs presents a timely and authoritative reviewof the central statistical concepts used to build clinical trials that obtain the best results. The referenceunveils modern approaches vital to understanding, creating, and evaluating data obtained throughoutthe various stages of clinical trial design and analysis. Accessible and comprehensive, the first volume in a two-part set includes newly-written articles as well as established literature from the Wiley Encyclopedia of Clinical Trials. Illustrating a variety of statistical concepts and principles such as longitudinal data, missing data, covariates, biased-coin randomization, repeated measurements, and simple randomization, the book also provides in-depth coverage of the various trial designs found within phase I-IV trials. Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs also features: Detailed chapters on the type of trial designs, such as adaptive, crossover, group-randomized, multicenter, non-inferiority, non-randomized, open-labeled, preference, prevention, and superiority trials Over 100 contributions from leading academics, researchers, and practitioners An exploration of ongoing, cutting-edge clinical trials on early cancer and heart disease, mother-to-child human immunodeficiency virus transmission trials, and the AIDS Clinical Trials Group Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs is an excellent reference for researchers, practitioners, and students in the fields of clinicaltrials, pharmaceutics, biostatistics, medical research design, biology, biomedicine, epidemiology,and public health.

Statistical Methods In Drug Combination Studies

DOWNLOAD
Author : Wei Zhao
language : en
Publisher: CRC Press
Release Date : 2014-12-19

Statistical Methods In Drug Combination Studies written by Wei Zhao and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-12-19 with Mathematics categories.

The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. Howeve

Methods And Applications Of Statistics In Clinical Trials Volume 2

DOWNLOAD
Author : Narayanaswamy Balakrishnan
language : en
Publisher: John Wiley & Sons
Release Date : 2014-06-09

Methods And Applications Of Statistics In Clinical Trials Volume 2 written by Narayanaswamy Balakrishnan 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 2014-06-09 with Medical categories.

Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods includes updates of established literature from the Wiley Encyclopedia of Clinical Trials as well as original material based on the latest developments in clinical trials. Prepared by a leading expert, the second volume includes numerous contributions from current prominent experts in the field of medical research. In addition, the volume features: • Multiple new articles exploring emerging topics, such as evaluation methods with threshold, empirical likelihood methods, nonparametric ROC analysis, over- and under-dispersed models, and multi-armed bandit problems • Up-to-date research on the Cox proportional hazard model, frailty models, trial reports, intrarater reliability, conditional power, and the kappa index • Key qualitative issues including cost-effectiveness analysis, publication bias, and regulatory issues, which are crucial to the planning and data management of clinical trials

Statistical Issues In Drug Development

DOWNLOAD
Author : Stephen S. Senn
language : en
Publisher: John Wiley & Sons
Release Date : 2008-02-28

Statistical Issues In Drug Development written by Stephen S. Senn 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 2008-02-28 with Medical categories.

Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component.

Handbook Of Statistical Methods For Precision Medicine

DOWNLOAD
Author : Eric Laber
language : en
Publisher: CRC Press
Release Date : 2024-10-23

Handbook Of Statistical Methods For Precision Medicine written by Eric Laber and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-10-23 with Mathematics categories.

The statistical study and development of analytic methodology for individualization of treatments is no longer in its infancy. Many methods of study design, estimation, and inference exist, and the tools available to the analyst are ever growing. This handbook introduces the foundations of modern statistical approaches to precision medicine, bridging key ideas to active lines of current research in precision medicine. The contributions in this handbook vary in their level of assumed statistical knowledge; all contributions are accessible to a wide readership of statisticians and computer scientists including graduate students and new researchers in the area. Many contributions, particularly those that are more comprehensive reviews, are suitable for epidemiologists and clinical researchers with some statistical training. The handbook is split into three sections: Study Design for Precision Medicine, Estimation of Optimal Treatment Strategies, and Precision Medicine in High Dimensions. The first focuses on designed experiments, in many instances, building and extending on the notion of sequential multiple assignment randomized trials. Dose finding and simulation-based designs using agent-based modelling are also featured. The second section contains both introductory contributions and more advanced methods, suitable for estimating optimal adaptive treatment strategies from a variety of data sources including non-experimental (observational) studies. The final section turns to estimation in the many-covariate setting, providing approaches suitable to the challenges posed by electronic health records, wearable devices, or any other settings where the number of possible variables (whether confounders, tailoring variables, or other) is high. Together, these three sections bring together some of the foremost leaders in the field of precision medicine, offering new insights and ideas as this field moves towards its third decade.

Handbook Of Methods For Designing Monitoring And Analyzing Dose Finding Trials

DOWNLOAD
Author : John O'Quigley
language : en
Publisher: CRC Press
Release Date : 2017-04-27

Handbook Of Methods For Designing Monitoring And Analyzing Dose Finding Trials written by John O'Quigley and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-04-27 with Mathematics categories.

Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials gives a thorough presentation of state-of-the-art methods for early phase clinical trials. The methodology of clinical trials has advanced greatly over the last 20 years and, arguably, nowhere greater than that of early phase studies. The need to accelerate drug development in a rapidly evolving context of targeted therapies, immunotherapy, combination treatments and complex group structures has provided the stimulus to these advances. Typically, we deal with very small samples, sequential methods that need to be efficient, while, at the same time adhering to ethical principles due to the involvement of human subjects. Statistical inference is difficult since the standard techniques of maximum likelihood do not usually apply as a result of model misspecification and parameter estimates lying on the boundary of the parameter space. Bayesian methods play an important part in overcoming these difficulties, but nonetheless, require special consideration in this particular context. The purpose of this handbook is to provide an expanded summary of the field as it stands and also, through discussion, provide insights into the thinking of leaders in the field as to the potential developments of the years ahead. With this goal in mind we present: An introduction to the field for graduate students and novices A basis for more established researchers from which to build A collection of material for an advanced course in early phase clinical trials A comprehensive guide to available methodology for practicing statisticians on the design and analysis of dose-finding experiments An extensive guide for the multiple comparison and modeling (MCP-Mod) dose-finding approach, adaptive two-stage designs for dose finding, as well as dose–time–response models and multiple testing in the context of confirmatory dose-finding studies. John O’Quigley is a professor of mathematics and research director at the French National Institute for Health and Medical Research based at the Faculty of Mathematics, University Pierre and Marie Curie in Paris, France. He is author of Proportional Hazards Regression and has published extensively in the field of dose finding. Alexia Iasonos is an associate attending biostatistician at the Memorial Sloan Kettering Cancer Center in New York. She has over one hundred publications in the leading statistical and clinical journals on the methodology and design of early phase clinical trials. Dr. Iasonos has wide experience in the actual implementation of model based early phase trials and has given courses in scientific meetings internationally. Björn Bornkamp is a statistical methodologist at Novartis in Basel, Switzerland, researching and implementing dose-finding designs in Phase II clinical trials. He is one of the co-developers of the MCP-Mod methodology for dose finding and main author of the DoseFinding R package. He has published numerous papers on dose finding, nonlinear models and Bayesian statistics, and in 2013 won the Royal Statistical Society award for statistical excellence in the pharmaceutical industry.

Statistical Methods For Evaluating Safety In Medical Product Development

DOWNLOAD
Author : A. Lawrence Gould
language : en
Publisher: John Wiley & Sons
Release Date : 2014-12-08

Statistical Methods For Evaluating Safety In Medical Product Development written by A. Lawrence Gould 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 2014-12-08 with Medical categories.

This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code

Statistical Methods For Trend Detection And Analysis In The Environmental Sciences

DOWNLOAD
Author : Richard Chandler
language : en
Publisher: John Wiley & Sons
Release Date : 2011-03-25

Statistical Methods For Trend Detection And Analysis In The Environmental Sciences written by Richard Chandler 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 2011-03-25 with Mathematics categories.

The need to understand and quantify change is fundamental throughout the environmental sciences. This might involve describing past variation, understanding the mechanisms underlying observed changes, making projections of possible future change, or monitoring the effect of intervening in some environmental system. This book provides an overview of modern statistical techniques that may be relevant in problems of this nature. Practitioners studying environmental change will be familiar with many classical statistical procedures for the detection and estimation of trends. However, the ever increasing capacity to collect and process vast amounts of environmental information has led to growing awareness that such procedures are limited in the insights that they can deliver. At the same time, significant developments in statistical methodology have often been widely dispersed in the statistical literature and have therefore received limited exposure in the environmental science community. This book aims to provide a thorough but accessible review of these developments. It is split into two parts: the first provides an introduction to this area and the second part presents a collection of case studies illustrating the practical application of modern statistical approaches to the analysis of trends in real studies. Key Features: Presents a thorough introduction to the practical application and methodology of trend analysis in environmental science. Explores non-parametric estimation and testing as well as parametric techniques. Methods are illustrated using case studies from a variety of environmental application areas. Looks at trends in all aspects of a process including mean, percentiles and extremes. Supported by an accompanying website featuring datasets and R code. The book is designed to be accessible to readers with some basic statistical training, but also contains sufficient detail to serve as a reference for practising statisticians. It will therefore be of use to postgraduate students and researchers both in the environmental sciences and in statistics.