Book Description
There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities.
- Provides a practical overview of data monitoring in clinical trials.
- Describes the purpose, responsibilities and operation of data monitoring committees.
- Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees.
- Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees.
- Discusses issues pertinent to those working in clinical trials in both the US and Europe.
The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.
Download Description
There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities. Provides a practical overview of data monitoring in clinical trials. Describes the purpose, responsibilities and operation of data monitoring committees. Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees. Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees. Discusses issues pertinent to those working in clinical trials in both the US and Europe. The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.
Customer Reviews:
Excellent Guide.......2006-12-27
All or almost all significant clinical trials involve Data Monitoring Committees (DMCs; also known as Data Safety and Monitoring Committees; DSMBs). These bodies provide independent oversight of the safety and operation of clinical trials. This book is a well organized and clearly written discussion of the operation of DMCs/DSMBs. Very practically oriented, the book discusses virtually all aspects of DMCs/DSMBs from their rationale to the nuts and bolts of running committee meetings. In addition to being comprehensive, this book is distinguished by the liberal and appropriate use of numerous concrete examples to illustrate many of the issues that come up in the operation of a DMC/DSMB. This book should be read and owned by anyone serving on a DMC/DSMB. Anyone heavily involved in clinical trials should be familiar with the contents of this book.
Book Description
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.
Order a copy of this author’s comprehensive text TODAY!
The Bayesian approach involves synthesising data and judgement in order to reach conclusions about unknown quantities and make predictions. Bayesian methods have become increasingly popular in recent years, notably in medical research, and although there are a number of books on Bayesian analysis, few cover clinical trials and biostatistical applications in any detail. Bayesian Approaches to Clinical Trials and Health-Care Evaluation provides a valuable overview of this rapidly evolving field, including basic Bayesian ideas, prior distributions, clinical trials, observational studies, evidence synthesis and cost-effectiveness analysis.
Covers a broad array of essential topics, building from the basics to more advanced techniques.
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Illustrated throughout by detailed case studies and worked examples
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Includes exercises in all chapters
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Accessible to anyone with a basic knowledge of statistics
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Authors are at the forefront of research into Bayesian methods in medical research
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Accompanied by a Web site featuring data sets and worked examples using Excel and WinBUGS - the most widely used Bayesian modelling package
Bayesian Approaches to Clinical Trials and Health-Care Evaluation is suitable for students and researchers in medical statistics, statisticians in the pharmaceutical industry, and anyone involved in conducting clinical trials and assessment of health-care technology.
Download Description
The Bayesian approach involves collecting data from past experience in order to reach conclusions about future events. Bayesian methods have become increasingly popular in recent years, notably in medical research. There are a large number of books on Bayesian analysis, but very few that cover clinical trials and biostatistical applications in any capacity. There is no book available that is introductory in nature and covers such a broad array of essential topics. This book provides a valuable overview of this rapidly evolving field, not only for statisticians in the pharmaceutical industry, but also to anyone involved in conducting clinical trials and HTA work. Comprehensive coverage of Bayesian methods in medical research
- Illustrated throughout by case studies and worked examples
- Authors are at the forefront of research into Bayesian methods in medical research
- Suitable for those with a limited statistical background
- Accompanied by a Web site featuring data sets and worked examples in WinBUGS - the most widely accepted Bayesian modelling package
Customer Reviews:
Bayes for Health Technology Assessment.......2006-07-23
This is an excellent introduction to Bayesian methods for anyone conducting health technology assessment, meta-analysis, and health economic analysis. Even if you're not a Bayesian, it adds depth and perspective to universal concepts such as statistical power, generalizability, and hypothesis testing. The chapters on cost-effectiveness and evidence-synthesis will be invaluable to anyone conducting pharmacoeconomics models or health technology assessments of pharmaceuticals or medical devices.
Book Description
Medical decision making has evolved in recent years, as more complex problems are being faced and addressed based on increasingly large amounts of data. In parallel, advances in computing have led to a host of new and powerful statistical tools to support decision making. Simulation-based Bayesian methods are especially promising, as they provide a unified framework for data collection, inference, and decision making. In addition, these methods are simple to interpret, and can help to address the most pressing practical and ethical concerns arising in medical decision making.
- Provides an overview of the necessary methodological background, including Bayesian inference, Monte Carlo simulation, and utility theory.
- Driven by three real applications, presented as extensively detailed case studies.
- Case studies include simplified versions of the analysis, to approach complex modelling in stages.
- Features coverage of meta-analysis, decision analysis, and comprehensive decision modeling.
- Accessible to readers with only a basic statistical knowledge.
Primarily aimed at students and practitioners of biostatistics, the book will also appeal to those working in statistics, medical informatics, evidence-based medicine, health economics, health services research, and health policy.
Book Description
Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities.
Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. This text presents the required statistical methods, and with an outstanding practical emphasis, demonstrates their applications through numerous examples using real data from drug development.
- Includes all the necessary pharmacokinetic background information.
- Presents parametric and nonparametric statistical techniques.
- Describes adequate methods for power and sample size determination.
- Includes appropriate presentation of results from bioequivalence studies.
- Provides a practical overview of the design and analysis of bioequivalence studies.
- Presents the recent developments in methodology, including population and individual bioequivalence.
- Reviews the regulatory guidelines for such studies, and the existing global discrepancies.
- Discusses the designs and analyses of drug-drug and food-drug interaction studies.
Bioequivalence Studies in Drug Development is written in an accessible style that makes it ideal for pharmaceutical scientists, clinical pharmacologists, and medical practitioners, as well as biometricians working in the pharmaceutical industry. It will also be of great value for professionals from regulatory bodies assessing bioequivalence studies.
Book Description
3-2-1 Code It! is your comprehensive learning solution for coding. This exciting new book combines ICD-9-CM, HCPCS level II and CPT coding concepts into one convenient learning package. This book presumes no prior knowledge of coding, and yet offers a level of detail suitable for both beginning and more experienced coders. Each coding chapter contains case studies to guide the user through the assignment of codes, and contains the most up-to-date information regarding coding guidelines and reimbursement issues. Also includes information on career opportunities for coders, the importance of joining professional organizations and obtaining credentials, the impact of working with other coding professionals, and how to develop opportunities for career advancement.
Book Description
Missing Data in Clinical Studies provides a comprehensive account of the problems arising when data from clinical and related studies are incomplete, and presents the reader with approaches to effectively address them. The text provides a critique of conventional and simple methods before moving on to discuss more advanced approaches. The authors focus on practical and modeling concepts, providing an extensive set of case studies to illustrate the problems described.
- Provides a practical guide to the analysis of clinical trials and related studies with missing data.
- Examines the problems caused by missing data, enabling a complete understanding of how to overcome them.
- Presents conventional, simple methods to tackle these problems, before addressing more advanced approaches, including sensitivity analysis, and the MAR missingness mechanism.
- Illustrated throughout with real-life case studies and worked examples from clinical trials.
- Details the use and implementation of the necessary statistical software, primarily SAS.
Missing Data in Clinical Studies has been developed through a series of courses and lectures. Its practical approach will appeal to applied statisticians and biomedical researchers, in particular those in the biopharmaceutical industry, medical and public health organisations. Graduate students of biostatistics will also find much of benefit.
Book Description
A unique overview that melds the concepts of conditional probability and stochastic processes into real-life applications
The role of randomization techniques in clinical trials has become increasingly important. This comprehensive guide combines both the applied aspects of randomization in clinical trials with a probabilistic treatment of properties of randomization. Taking an unabashedly non-Bayesian and nonparametric approach to inference, the book focuses on the linear rank test under a randomization model, with added discussion on likelihood-based inference as it relates to sufficiency and ancillarity. Developments in stochastic processes and applied probability are also given where appropriate. Intuition is stressed over mathematics, but not without a clear development of the latter in the context of the former.
Providing a consolidated review of the field, the book includes relevant 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 computer simulations using SAS, Randomization in Clinical Trials: Theory and Practice is equally useful as a standard textbook in biostatistics graduate programs as well as a reliable reference for biostatisticians in practice.
Download Description
A unique overview that melds the concepts of conditional probability and stochastic processes into real-life applications
The role of randomization techniques in clinical trials has become increasingly important. This comprehensive guide combines both the applied aspects of randomization in clinical trials with a probabilistic treatment of properties of randomization. Taking an unabashedly non-Bayesian and nonparametric approach to inference, the book focuses on the linear rank test under a randomization model, with added discussion on likelihood-based inference as it relates to sufficiency and ancillarity. Developments in stochastic processes and applied probability are also given where appropriate. Intuition is stressed over mathematics, but not without a clear development of the latter in the context of the former.
Providing a consolidated review of the field, the book includes relevant 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 computer simulations using SAS, Randomization in Clinical Trials: Theory and Practice is equally useful as a standard textbook in biostatistics graduate programs as well as a reliable reference for biostatisticians in practice.
Book Description
Cross-over trials are an important class of design used in the pharmaceutical industry and medical research, and their use continues to grow. Cross-over Trials in Clinical Research, Second Edition has been fully updated to include the latest methodology used in the design and analysis of cross-over trials. It includes more background material, greater coverage of important statistical techniques, including Bayesian methods, and discussion of analysis using a number of statistical software packages.
* Comprehensive coverage of the design and analysis of cross-over trials.
* Each technique is carefully explained and the mathematics is kept to a minimum.
* Features many real and original examples, taken from the author's vast experience.
* Includes discussion of analysis using SAS, S-Plus and, GenStat, StatXact and Excel.
* Written in a style suitable for statisticians and physicians alike.
* Computer programs to accompany the examples in the book can be downloaded from the Web
Primarily aimed at statisticians and researchers working in the pharmaceutical industry, the book will also appeal to physicians involved in clinical research and students of medical statistics.
Download Description
"Cross-over trials are an important class of design used in the pharmaceutical industry and medical research, and their use continues to grow. Cross-over Trials in Clinical Research, Second Edition has been fully updated to include the latest methodology used in the design and analysis of cross-over trials. It includes more background material, greater coverage of important statistical techniques, including Bayesian methods, and discussion of analysis using a number of statistical software packages. Comprehensive coverage of the design and analysis of cross-over trials. Each technique is carefully explained and the mathematics is kept to a minimum. Features many real and original examples, taken from the author's vast experience. Includes discussion of analysis using SAS, S-Plus and, GenStat, StatXact and Excel. Written in a style suitable for statisticians and physicians alike. Primarily aimed at statisticians and researchers working in the pharmaceutical industry, the book will also appeal to physicians involved in clinical research and students of medical statistics."
Book Description
The not-to-be-missed, benchmark volume on the growing area of stud in the PharmD pharmacy curriculum. Provides a foundation for assessing the nature and extent of drug-taking behaviors. Text is adapted from the author's self-paced learning modules, developed for the Massachusetts College of Pharmacy.
Book Description
A practical guide to methods of survival analysis for medical researchers with limited statistical experience. Methods and techniques described range from descriptive and exploratory analysis to multivariate regression methods. Uses illustrative data from actual clinical trials and observational studies to describe methods of analysing and reporting results. Also reviews the features and performance of statistical software available for applying the methods of analysis discussed.
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General
| Science
| Subjects
| Books
Data Monitoring in Clinical Trials: A Case Studies Approach
Fundamentals of Clinical Trials
Group Sequential Methods: Applications to Clinical Trials (Chapman & Hall/Crc Interdisciplinary Statistics Series)
Statistical Monitoring of Clinical Trials: A Unified Approach (Statistics for Biology and Health)
Sample Size Calculations in Clinical Research (Biostatistics, 11)
