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An Introduction To Statistics In Early Phase Trials


An Introduction To Statistics In Early Phase Trials
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An Introduction To Statistics In Early Phase Trials


An Introduction To Statistics In Early Phase Trials
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Author : Steven Julious
language : en
Publisher: John Wiley & Sons
Release Date : 2010-01-19

An Introduction To Statistics In Early Phase Trials written by Steven Julious 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 2010-01-19 with Medical categories.


All new medicines and devices undergo early phase trials to assess, interpret and better understand their efficacy, tolerability and safety. An Introduction to Statistics in Early Phase Trials describes the practical design and analysis of these important early phase clinical trials and provides the crucial statistical basis for their interpretation. It clearly and concisely provides an overview of the most common types of trials undertaken in early phase clinical research and explains the different methodologies used. The impact of statistical technologies on clinical development and the statistical and methodological basis for making clinical and investment decisions are also explained. Conveys key ideas in a concise manner understandable by non-statisticians Explains how to optimise designs in a constrained or fixed resource setting Discusses decision making criteria at the end of Phase II trials Highlights practical day-to-day issues and reporting of early phase trials An Introduction to Statistics in Early Phase Trials is an essential guide for all researchers working in early phase clinical trial development, from clinical pharmacologists and pharmacokineticists through to clinical investigators and medical statisticians. It is also a valuable reference for teachers and students of pharmaceutical medicine learning about the design and analysis of clinical trials.



Introduction To Randomized Controlled Clinical Trials


Introduction To Randomized Controlled Clinical Trials
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Author : John N.S. Matthews
language : en
Publisher: CRC Press
Release Date : 2006-06-26

Introduction To Randomized Controlled Clinical Trials written by John N.S. Matthews and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-06-26 with Mathematics categories.


Evidence from randomized controlled clinical trials is widely accepted as the only sound basis for assessing the efficacy of new medical treatments. Statistical methods play a key role in all stages of these trials, including their justification, design, and analysis. This second edition of Introduction to Randomized Controlled Clinical Trials prov



Sequential Experimentation In Clinical Trials


Sequential Experimentation In Clinical Trials
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Author : Jay Bartroff
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-12

Sequential Experimentation In Clinical Trials written by Jay Bartroff and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-12 with Medical categories.


Sequential Experimentation in Clinical Trials: Design and Analysis is developed from decades of work in research groups, statistical pedagogy, and workshop participation. Different parts of the book can be used for short courses on clinical trials, translational medical research, and sequential experimentation. The authors have successfully used the book to teach innovative clinical trial designs and statistical methods for Statistics Ph.D. students at Stanford University. There are additional online supplements for the book that include chapter-specific exercises and information. Sequential Experimentation in Clinical Trials: Design and Analysis covers the much broader subject of sequential experimentation that includes group sequential and adaptive designs of Phase II and III clinical trials, which have attracted much attention in the past three decades. In particular, the broad scope of design and analysis problems in sequential experimentation clearly requires a wide range of statistical methods and models from nonlinear regression analysis, experimental design, dynamic programming, survival analysis, resampling, and likelihood and Bayesian inference. The background material in these building blocks is summarized in Chapter 2 and Chapter 3 and certain sections in Chapter 6 and Chapter 7. Besides group sequential tests and adaptive designs, the book also introduces sequential change-point detection methods in Chapter 5 in connection with pharmacovigilance and public health surveillance. Together with dynamic programming and approximate dynamic programming in Chapter 3, the book therefore covers all basic topics for a graduate course in sequential analysis designs.



The Prevention And Treatment Of Missing Data In Clinical Trials


The Prevention And Treatment Of Missing Data In Clinical Trials
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2010-12-21

The Prevention And Treatment Of Missing Data In Clinical Trials written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-21 with Medical categories.


Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.



Fundamentals Of Clinical Trials


Fundamentals Of Clinical Trials
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Author : Lawrence M. Friedman
language : en
Publisher: Springer Science & Business Media
Release Date : 1998

Fundamentals Of Clinical Trials written by Lawrence M. Friedman and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998 with Medical categories.


This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.



An Introduction To Clinical Trials


An Introduction To Clinical Trials
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Author : Jonathan A. Cook
language : en
Publisher: Oxford University Press
Release Date : 2023

An Introduction To Clinical Trials written by Jonathan A. Cook and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023 with Computers categories.


An Introduction to clinical trials is a concise step-by-step guide to the principles and practices of clinical trials for those studying clinical trials or new to working on one. Clinical trials are critical to the progress of medicine and improving healthcare, as they evaluate whether new treatments and interventions work. They are also complex, multidisciplinary projects that integrate science, ethics, and legal requirements in the conduct of medical research. Starting with the research question, An Introduction to clinical trials explains study design, sample size determination, study set-up, study conduct, statistical analysis, and dissemination of the results. The book primarily focusses on randomised controlled trials as the "ultimate" clinical trial. It demystifies the terminology used in clinical trials research and presents the underlying scientific and statistical concepts. Real-life examples are used throughout to bring concepts to life. Written by an experienced medical statistician, An Introduction to clinical trials will benefit readers of all backgrounds, from postgraduate and medical students, trainee doctors and healthcare professionals to others working on clinical trials in a professional capacity. This book aims to help readers gain a fuller and more rounded understanding of clinical trials.



Integrated Cardiac Safety


Integrated Cardiac Safety
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Author : J. Rick Turner
language : en
Publisher: John Wiley & Sons
Release Date : 2008-11-26

Integrated Cardiac Safety written by J. Rick Turner 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 2008-11-26 with Medical categories.


The serious nature of cardiovascular adverse drug reactions occurring in patients makes assessment of a drug's cardiac safety profile a high priority during both development and post-approval monitoring. Integrated Cardiac Safety provides necessary guidance and methodology for professionals assessing cardiac safety of drugs throughout all stages of the drug's life, from discovery and development through postmarketing research. This self-contained, reader-friendly text is valuable to professionals in the pharmaceutical, biotechnology, and CRO industries, pharmacologists, toxicologists, government officials, and students.



Statistical Methods In Biomarker And Early Clinical Development


Statistical Methods In Biomarker And Early Clinical Development
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Author : Liang Fang
language : en
Publisher: Springer Nature
Release Date : 2019-12-26

Statistical Methods In Biomarker And Early Clinical Development written by Liang Fang and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-12-26 with Medical categories.


This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters are written by expert statisticians with extensive experience in the pharmaceutical industry and regulatory agencies. Because of this, the data presented is often accompanied by real world case studies, which will help make examples more tangible for readers. The many applications of statistics in drug development are covered in detail, making this volume a must-have reference. Biomarker development and early clinical development are the two critical areas on which the book focuses. By having the two sections of the book dedicated to each of these topics, readers will have a more complete understanding of how applying statistical methods to early drug development can help identify the right drug for the right patient at the right dose. Also presented are exciting applications of machine learning and statistical modeling, along with innovative methods and state-of-the-art advances, making this a timely and practical resource. This volume is ideal for statisticians, researchers, and professionals interested in pharmaceutical research and development. Readers should be familiar with the fundamentals of statistics and clinical trials.



An Introduction To Medical Statistics


An Introduction To Medical Statistics
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Author : Martin Bland
language : en
Publisher: OUP Oxford
Release Date : 2015-07-23

An Introduction To Medical Statistics written by Martin Bland and has been published by OUP Oxford this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-23 with Medical categories.


Now in its Fourth Edition, An Introduction to Medical Statistics continues to be a 'must-have' textbook for anyone who needs a clear logical guide to the subject. Written in an easy-to-understand style and packed with real life examples, the text clearly explains the statistical principles used in the medical literature. Taking readers through the common statistical methods seen in published research and guidelines, the text focuses on how to interpret and analyse statistics for clinical practice. Using extracts from real studies, the author illustrates how data can be employed correctly and incorrectly in medical research helping readers to evaluate the statistics they encounter and appropriately implement findings in clinical practice. End of chapter exercises, case studies and multiple choice questions help readers to apply their learning and develop their own interpretative skills. This thoroughly revised edition includes new chapters on meta-analysis, missing data, and survival analysis.



Bayesian Approaches To Clinical Trials And Health Care Evaluation


Bayesian Approaches To Clinical Trials And Health Care Evaluation
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Author : David J. Spiegelhalter
language : en
Publisher: John Wiley & Sons
Release Date : 2004-01-16

Bayesian Approaches To Clinical Trials And Health Care Evaluation written by David J. Spiegelhalter 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 2004-01-16 with Mathematics categories.


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. Illustrated throughout by detailed case studies and worked examples Includes exercises in all chapters Accessible to anyone with a basic knowledge of statistics Authors are at the forefront of research into Bayesian methods in medical research 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.