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Dynamic Treatment Regimes Statistical Methods for Precision Medicine

Dynamic Treatment Regimes Statistical Methods for Precision Medicine

Dynamic Treatment Regimes: Statistical Methods for Precision Medicine provides a comprehensive introduction to statistical methodology for the evaluation and discovery of dynamic treatment regimes from data. Researchers and graduate students in statistics data science and related quantitative disciplines with a background in probability and statistical inference and popular statistical modeling techniques will be prepared for further study of this rapidly evolving field. A dynamic treatment regime is a set of sequential decision rules each corresponding to a key decision point in a disease or disorder process where each rule takes as input patient information and returns the treatment option he or she should receive. Thus a treatment regime formalizes how a clinician synthesizes patient information and selects treatments in practice. Treatment regimes are of obvious relevance to precision medicine which involves tailoring treatment selection to patient characteristics in an evidence-based way. Of critical importance to precision medicine is estimation of an optimal treatment regime one that if used to select treatments for the patient population would lead to the most beneficial outcome on average. Key methods for estimation of an optimal treatment regime from data are motivated and described in detail. A dedicated companion website presents full accounts of application of the methods using a comprehensive R package developed by the authors. The authors’ website www. dtr-book. com includes updates corrections new papers and links to useful websites. | Dynamic Treatment Regimes Statistical Methods for Precision Medicine

GBP 44.99
1

Financial Mathematics A Comprehensive Treatment in Continuous Time Volume II

Financial Mathematics A Comprehensive Treatment in Continuous Time Volume II

The book has been tested and refined through years of classroom teaching experience. With an abundance of examples problems and fully worked out solutions the text introduces the financial theory and relevant mathematical methods in a mathematically rigorous yet engaging way. This textbook provides complete coverage of continuous-time financial models that form the cornerstones of financial derivative pricing theory. Unlike similar texts in the field this one presents multiple problem-solving approaches linking related comprehensive techniques for pricing different types of financial derivatives. Key features: In-depth coverage of continuous-time theory and methodology Numerous fully worked out examples and exercises in every chapter Mathematically rigorous and consistent yet bridging various basic and more advanced concepts Judicious balance of financial theory and mathematical methods Guide to Material This revision contains: Almost 150 pages worth of new material in all chapters A appendix on probability theory An expanded set of solved problems and additional exercises Answers to all exercises This book is a comprehensive self-contained and unified treatment of the main theory and application of mathematical methods behind modern-day financial mathematics. The text complements Financial Mathematics: A Comprehensive Treatment in Discrete Time by the same authors also published by CRC Press. | Financial Mathematics A Comprehensive Treatment in Continuous Time Volume II

GBP 84.99
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Financial Mathematics A Comprehensive Treatment in Discrete Time

Financial Mathematics A Comprehensive Treatment in Discrete Time

The book has been tested and refined through years of classroom teaching experience. With an abundance of examples problems and fully worked out solutions the text introduces the financial theory and relevant mathematical methods in a mathematically rigorous yet engaging way. This textbook provides complete coverage of discrete-time financial models that form the cornerstones of financial derivative pricing theory. Unlike similar texts in the field this one presents multiple problem-solving approaches linking related comprehensive techniques for pricing different types of financial derivatives. Key features: In-depth coverage of discrete-time theory and methodology. Numerous fully worked out examples and exercises in every chapter. Mathematically rigorous and consistent yet bridging various basic and more advanced concepts. Judicious balance of financial theory mathematical and computational methods. Guide to Material. This revision contains: Almost 200 pages worth of new material in all chapters. A new chapter on elementary probability theory. An expanded the set of solved problems and additional exercises. Answers to all exercises. This book is a comprehensive self-contained and unified treatment of the main theory and application of mathematical methods behind modern-day financial mathematics. | Financial Mathematics A Comprehensive Treatment in Discrete Time

GBP 89.99
1

Introduction to Mathematical Oncology

Introduction to Mathematical Oncology

Introduction to Mathematical Oncology presents biologically well-motivated and mathematically tractable models that facilitate both a deep understanding of cancer biology and better cancer treatment designs. It covers the medical and biological background of the diseases modeling issues and existing methods and their limitations. The authors introduce mathematical and programming tools along with analytical and numerical studies of the models. They also develop new mathematical tools and look to future improvements on dynamical models. After introducing the general theory of medicine and exploring how mathematics can be essential in its understanding the text describes well-known practical and insightful mathematical models of avascular tumor growth and mathematically tractable treatment models based on ordinary differential equations. It continues the topic of avascular tumor growth in the context of partial differential equation models by incorporating the spatial structure and physiological structure such as cell size. The book then focuses on the recent active multi-scale modeling efforts on prostate cancer growth and treatment dynamics. It also examines more mechanistically formulated models including cell quota-based population growth models with applications to real tumors and validation using clinical data. The remainder of the text presents abundant additional historical biological and medical background materials for advanced and specific treatment modeling efforts. Extensively classroom-tested in undergraduate and graduate courses this self-contained book allows instructors to emphasize specific topics relevant to clinical cancer biology and treatment. It can be used in a variety of ways including a single-semester undergraduate course a more ambitious graduate course or a full-year sequence on mathematical oncology.

GBP 44.99
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Pricing in General Insurance

Pricing in General Insurance

Based on the syllabus of the actuarial profession courses on general insurance pricing – with additional material inspired by the author’s own experience as a practitioner and lecturer – Pricing in General Insurance Second Edition presents pricing as a formalised process that starts with collecting information about a particular policyholder or risk and ends with a commercially informed rate. The first edition of the book proved very popular among students and practitioners with its pragmatic approach informal style and wide-ranging selection of topics including: Background and context for pricing Process of experience rating ranging from traditional approaches (burning cost analysis) to more modern approaches (stochastic modelling) Exposure rating for both property and casualty products Specialised techniques for personal lines (e. g. GLMs) reinsurance and specific products such as credit risk and weather derivatives General-purpose techniques such as credibility multi-line pricing and insurance optimisation The second edition is a substantial update on the first edition including: New chapter on pricing models: their structure development calibration and maintenance New chapter on rate change calculations and the pricing cycle Substantially enhanced treatment of exposure rating increased limit factors burning cost analysis Expanded treatment of triangle-free techniques for claim count development Improved treatment of premium building and capital allocation Expanded treatment of machine learning Enriched treatment of rating factor selection and the inclusion of generalised additive models The book delivers a practical introduction to all aspects of general insurance pricing and is aimed at students of general insurance and actuarial science as well as practitioners in the field. It is complemented by online material such as spreadsheets which implement the techniques described in the book solutions to problems a glossary and other appendices – increasing the practical value of the book.

GBP 74.99
1

Bayesian Designs for Phase I-II Clinical Trials

Bayesian Designs for Phase I-II Clinical Trials

Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time if promising preclinical results do not translate into a real treatment advance it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center this book shows how Bayesian designs for early-phase clinical trials can explore refine and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity. | Bayesian Designs for Phase I-II Clinical Trials

GBP 38.99
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Exposure-Response Modeling Methods and Practical Implementation

Exposure-Response Modeling Methods and Practical Implementation

Discover the Latest Statistical Approaches for Modeling Exposure-Response RelationshipsWritten by an applied statistician with extensive practical experience in drug development Exposure-Response Modeling: Methods and Practical Implementation explores a wide range of topics in exposure-response modeling from traditional pharmacokinetic-pharmacodynamic (PKPD) modeling to other areas in drug development and beyond. It incorporates numerous examples and software programs for implementing novel methods. The book describes using measurement error models to treat sequential modeling fitting models with exposure and response driven by complex dynamics and survival analysis with dynamic exposure history. It also covers Bayesian analysis and model-based Bayesian decision analysis causal inference to eliminate confounding biases and exposure-response modeling with response-dependent dose/treatment adjustments (dynamic treatment regimes) for personalized medicine and treatment adaptation. Many examples illustrate the use of exposure-response modeling in experimental toxicology clinical pharmacology epidemiology and drug safety. Some examples demonstrate how to solve practical problems while others help with understanding concepts and evaluating the performance of new methods. The provided SAS and R codes enable readers to test the approaches in their own scenarios. Although application oriented this book also gives a systematic treatment of concepts and methodology. Applied statisticians and modelers can find details on how to implement new approaches. Researchers can find topics for or applications of their work. In addition students can see how complicated methodology and models are applied to practical situations. | Exposure-Response Modeling Methods and Practical Implementation

GBP 44.99
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Robust Statistical Methods with R Second Edition

Robust Statistical Methods with R Second Edition

The second edition of Robust Statistical Methods with R provides a systematic treatment of robust procedures with an emphasis on new developments and on the computational aspects. There are many numerical examples and notes on the R environment and the updated chapter on the multivariate model contains additional material on visualization of multivariate data in R. A new chapter on robust procedures in measurement error models concentrates mainly on the rank procedures less sensitive to errors than other procedures. This book will be an invaluable resource for researchers and postgraduate students in statistics and mathematics. Features• Provides a systematic practical treatment of robust statistical methods• Offers a rigorous treatment of the whole range of robust methods including the sequential versions of estimators their moment convergence and compares their asymptotic and finite-sample behavior• The extended account of multivariate models includes the admissibility shrinkage effects and unbiasedness of two-sample tests• Illustrates the small sensitivity of the rank procedures in the measurement error model• Emphasizes the computational aspects supplies many examples and illustrations and provides the own procedures of the authors in the R software on the book’s website | Robust Statistical Methods with R Second Edition

GBP 39.99
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Geometry and Its Applications

Geometry and Its Applications

This unique textbook combines traditional geometry presents a contemporary approach that is grounded in real-world applications. It balances the deductive approach with discovery learning introduces axiomatic Euclidean and non-Euclidean and transformational geometry. The text integrates applications and examples throughout. The Third Edition offers many updates including expaning on historical notes Geometry and Its Applications is a significant text for any college or university that focuses on geometry's usefulness in other disciplines. It is especially appropriate for engineering and science majors as well as future mathematics teachers. The Third Edition streamlines the treatment from the previous two editions Treatment of axiomatic geometry has been expanded Nearly 300 applications from all fields are included An emphasis on computer science-related applications appeals to student interest Many new excercises keep the presentation fresh

GBP 105.00
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Stochastic Differential Equations for Science and Engineering

Stochastic Differential Equations for Science and Engineering

Stochastic Differential Equations for Science and Engineering is aimed at students at the M. Sc. and PhD level. The book describes the mathematical construction of stochastic differential equations with a level of detail suitable to the audience while also discussing applications to estimation stability analysis and control. The book includes numerous examples and challenging exercises. Computational aspects are central to the approach taken in the book so the text is accompanied by a repository on GitHub containing a toolbox in R which implements algorithms described in the book code that regenerates all figures and solutions to exercises. Features: Contains numerous exercises examples and applications Suitable for science and engineering students at Master’s or PhD level Thorough treatment of the mathematical theory combined with an accessible treatment of motivating examples GitHub repository available at: https://github. com/Uffe-H-Thygesen/SDEbook and https://github. com/Uffe-H-Thygesen/SDEtools

GBP 89.99
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A Handbook of Statistical Analyses using SAS

A Handbook of Statistical Analyses using SAS

Updated to reflect SAS 9. 2 A Handbook of Statistical Analyses using SAS Third Edition continues to provide a straightforward description of how to conduct various statistical analyses using SAS. Each chapter shows how to use SAS for a particular type of analysis. The authors cover inference analysis of variance regression generalized linear models longitudinal data survival analysis principal components analysis factor analysis cluster analysis discriminant function analysis and correspondence analysis. They demonstrate the analyses through real-world examples including methadone maintenance treatment the relation of cirrhosis deaths to alcohol consumption a sociological study of children heart transplant treatment and crime rate determinants. With the data sets and SAS code available online this book remains the go-to resource for learning how to use SAS for many kinds of statistical analysis. It serves as a stepping stone to the wider resources available to SAS users.

GBP 180.00
1

Grothendieck Construction of Bipermutative-Indexed Categories

Grothendieck Construction of Bipermutative-Indexed Categories

The Grothendieck construction provides an explicit link between indexed categories and opfibrations. It is a fundamental concept in category theory and related fields with far-reaching applications. Bipermutative categories are categorifications of rings. They play a central role in algebraic K-theory and infinite loop space theory. This monograph is a detailed study of the Grothendieck construction over a bipermutative category in the context of categorically enriched multicategories with new and important applications to inverse K-theory and pseudo symmetric E∞-algebras. After carefully recalling preliminaries in enriched categories bipermutative categories and enriched multicategories we show that the Grothendieck construction over a small tight bipermutative category is a pseudo symmetric Cat-multifunctor and generally not a Cat-multifunctor in the symmetric sense. Pseudo symmetry of Cat-multifunctors is a new concept we introduce in this work. The following features make it accessible as a graduate text or reference for experts: Complete definitions and proofs Self-contained background. Parts of Chapters 1–3 7 9 and 10 contain background material from the research literature Extensive cross-references Connections between chapters. Each chapter has its own introduction discussing not only the topics of that chapter but also its connection with other chapters Open questions. Appendix A contains open questions that arise from the material in the text and are suitable for graduate students This book is suitable for graduate students and researchers with an interest in category theory algebraic K-theory homotopy theory and related fields. The presentation is thorough and self-contained with complete details and background material for non-expert readers. | Grothendieck Construction of Bipermutative-Indexed Categories

GBP 110.00
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Simple Extensions with the Minimum Degree Relations of Integral Domains

Simple Extensions with the Minimum Degree Relations of Integral Domains

Although there are many types of ring extensions simple extensions have yet to be thoroughly explored in one book. Covering an understudied aspect of commutative algebra Simple Extensions with the Minimum Degree Relations of Integral Domains presents a comprehensive treatment of various simple extensions and their properties. In particular it examines several properties of simple ring extensions of Noetherian integral domains. As experts who have been studying this field for over a decade the authors present many arguments that they have developed themselves mainly exploring anti-integral super-primitive and ultra-primitive extensions. Within this framework they study certain properties such as flatness integrality and unramifiedness. Some of the topics discussed include Sharma polynomials vanishing points Noetherian domains denominator ideals unit groups and polynomial rings. Presenting a complete treatment of each topic Simple Extensions with the Minimum Degree Relations of Integral Domains serves as an ideal resource for graduate students and researchers involved in the area of commutative algebra.

GBP 180.00
1

Basic Matrix Algebra with Algorithms and Applications

Basic Matrix Algebra with Algorithms and Applications

Clear prose tight organization and a wealth of examples and computational techniques make Basic Matrix Algebra with Algorithms and Applications an outstanding introduction to linear algebra. The author designed this treatment specifically for freshman majors in mathematical subjects and upper-level students in natural resources the social sciences business or any discipline that eventually requires an understanding of linear models. With extreme pedagogical clarity that avoids abstraction wherever possible the author emphasizes minimal polynomials and their computation using a Krylov algorithm. The presentation is highly visual and relies heavily on work with a graphing calculator to allow readers to focus on concepts and techniques rather than on tedious arithmetic. Supporting materials including test preparation Maple worksheets are available for download from the Internet. This unassuming but insightful and remarkably original treatment is organized into bite-sized clearly stated objectives. It goes well beyond the LACSG recommendations for a first course while still implementing their philosophy and core material. Classroom tested with great success it prepares readers well for the more advanced studies their fields ultimately will require.

GBP 175.00
1

An Advanced Course in Probability and Stochastic Processes

An Advanced Course in Probability and Stochastic Processes

An Advanced Course in Probability and Stochastic Processes provides a modern and rigorous treatment of probability theory and stochastic processes at an upper undergraduate and graduate level. Starting with the foundations of measure theory this book introduces the key concepts of probability theory in an accessible way providing full proofs and extensive examples and illustrations. Fundamental stochastic processes such as Gaussian processes Poisson random measures Lévy processes Markov processes and Itô processes are presented and explored in considerable depth showcasing their many interconnections. Special attention is paid to martingales and the Wiener process and their central role in the treatment of stochastic integrals and stochastic calculus. This book includes many exercises designed to test and challenge the reader and expand their skillset. An Advanced Course in Probability and Stochastic Processes is meant for students and researchers who have a solid mathematical background and who have had prior exposure to elementary probability and stochastic processes. Key Features: Focus on mathematical understanding Rigorous and self-contained Accessible and comprehensive High-quality illustrations Includes essential simulation algorithms Extensive list of exercises and worked-out examples Elegant and consistent notation

GBP 89.99
1

Handbook of Statistical Methods and Analyses in Sports

Handbook of Statistical Methods and Analyses in Sports

This handbook will provide both overviews of statistical methods in sports and in-depth treatment of critical problems and challenges confronting statistical research in sports. The material in the handbook will be organized by major sport (baseball football hockey basketball and soccer) followed by a section on other sports and general statistical design and analysis issues that are common to all sports. This handbook has the potential to become the standard reference for obtaining the necessary background to conduct serious statistical analyses for sports applications and to appreciate scholarly work in this expanding area. | Handbook of Statistical Methods and Analyses in Sports

GBP 58.99
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Mathematics of Keno and Lotteries

Mathematics of Keno and Lotteries

Mathematics of Keno and Lotteries is an elementary treatment of the mathematics primarily probability and simple combinatorics involved in lotteries and keno. Keno has a long history as a high-advantage high-payoff casino game and state lottery games such as Powerball are mathematically similar. MKL also considers such lottery games as passive tickets daily number drawings and specialized games offered around the world. In addition there is a section on financial mathematics that explains the connection between lump-sum lottery prizes (as with Powerball) and their multi-year annuity options. So-called winning systems for keno and lotteries are examined mathematically and their flaws identified.

GBP 52.99
1

Handbook of Design and Analysis of Experiments

Handbook of Design and Analysis of Experiments

Handbook of Design and Analysis of Experiments provides a detailed overview of the tools required for the optimal design of experiments and their analyses. The handbook gives a unified treatment of a wide range of topics covering the latest developments. This carefully edited collection of 25 chapters in seven sections synthesizes the state of the art in the theory and applications of designed experiments and their analyses. Written by leading researchers in the field the chapters offer a balanced blend of methodology and applications. The first section presents a historical look at experimental design and the fundamental theory of parameter estimation in linear models. The second section deals with settings such as response surfaces and block designs in which the response is modeled by a linear model the third section covers designs with multiple factors (both treatment and blocking factors) and the fourth section presents optimal designs for generalized linear models other nonlinear models and spatial models. The fifth section addresses issues involved in designing various computer experiments. The sixth section explores cross-cutting issues relevant to all experimental designs including robustness and algorithms. The final section illustrates the application of experimental design in recently developed areas. This comprehensive handbook equips new researchers with a broad understanding of the field’s numerous techniques and applications. The book is also a valuable reference for more experienced research statisticians working in engineering and manufacturing the basic sciences and any discipline that depends on controlled experimental investigation.

GBP 66.99
1

Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials

Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials

Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials provides a practical introduction to unconditional approaches to planning randomised clinical trials particularly aimed at drug development in the pharmaceutical industry. This book is aimed at providing guidance to practitioners in using average power assurance and related concepts. This book brings together recent research and sets them in a consistent framework and provides a fresh insight into how such methods can be used. Features: A focus on normal theory linking average power expected power predictive power assurance conditional Bayesian power and Bayesian power. Extensions of the concepts to binomial and time-to-event outcomes and non-inferiority trials An investigation into the upper bound on average power assurance and Bayesian power based on the prior probability of a positive treatment effect Application of assurance to a series of trials in a development program and an introduction of the assurance of an individual trial conditional on the positive outcome of an earlier trial in the program or to the successful outcome of an interim analysis Prior distribution of power and sample size Extension of the basic approach to proof-of-concept trials with dual success criteria Investigation of the connection between conditional and predictive power at an interim analysis and power and assurance Introduction of the idea of surety in sample sizing of clinical trials based on the width of the confidence intervals for the treatment effect and an unconditional version.

GBP 99.99
1

Distributed Systems An Algorithmic Approach Second Edition

Distributed Systems An Algorithmic Approach Second Edition

Distributed Systems: An Algorithmic Approach Second Edition provides a balanced and straightforward treatment of the underlying theory and practical applications of distributed computing. As in the previous version the language is kept as unobscured as possible—clarity is given priority over mathematical formalism. This easily digestible text:Features significant updates that mirror the phenomenal growth of distributed systemsExplores new topics related to peer-to-peer and social networksIncludes fresh exercises examples and case studiesSupplying a solid understanding of the key principles of distributed computing and their relationship to real-world applications Distributed Systems: An Algorithmic Approach Second Edition makes both an ideal textbook and a handy professional reference. | Distributed Systems An Algorithmic Approach Second Edition

GBP 38.99
1

Classification of Lipschitz Mappings

Classification of Lipschitz Mappings

Classification of Lipschitz Mappings presents a systematic self-contained treatment of a new classification of Lipschitz mappings and its application in many topics of metric fixed point theory. Suitable for readers interested in metric fixed point theory differential equations and dynamical systems the book only requires a basic background in functional analysis and topology. The author focuses on a more precise classification of Lipschitzian mappings. The mean Lipschitz condition introduced by Goebel Japón Pineda and Sims is relatively easy to check and turns out to satisfy several principles: Regulating the possible growth of the sequence of Lipschitz constants k(Tn)Ensuring good estimates for k0(T) and k∞(T)Providing some new results in metric fixed point theory

GBP 59.99
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The Elements of Advanced Mathematics

The Elements of Advanced Mathematics

This book has enjoyed considerable use and appreciation during its first four editions. With hundreds of students having learned out of early editions the author continues to find ways to modernize and maintain a unique presentation. What sets the book apart is the excellent writing style exposition and unique and thorough sets of exercises. This edition offers a more instructive preface to assist instructors on developing the course they prefer. The prerequisites are more explicit and provide a roadmap for the course. Sample syllabi are included. As would be expected in a fifth edition the overall content and structure of the book are sound. This new edition offers a more organized treatment of axiomatics. Throughout the book there is a more careful and detailed treatment of the axioms of set theory. The rules of inference are more carefully elucidated. Additional new features include: An emphasis on the art of proof. Enhanced number theory chapter presents some easily accessible but still-unsolved problems. These include the Goldbach conjecture the twin prime conjecture and so forth. The discussion of equivalence relations is revised to present reflexivity symmetry and transitivity before we define equivalence relations. The discussion of the RSA cryptosystem in Chapter 8 is expanded. The author introduces groups much earlier. Coverage of group theory formerly in Chapter 11 has been moved up; this is an incisive example of an axiomatic theory. Recognizing new ideas the author has enhanced the overall presentation to create a fifth edition of this classic and widely-used textbook. | The Elements of Advanced Mathematics

GBP 82.99
1

Introduction to Information Theory and Data Compression

Introduction to Information Theory and Data Compression

An effective blend of carefully explained theory and practical applications this text imparts the fundamentals of both information theory and data compression. Although the two topics are related this unique text allows either topic to be presented independently and it was specifically designed so that the data compression section requires no prior knowledge of information theory. The treatment of information theory while theoretical and abstract is quite elementary making this text less daunting than many others. After presenting the fundamental definitions and results of the theory the authors then apply the theory to memoryless discrete channels with zeroth-order one-state sources. The chapters on data compression acquaint students with a myriad of lossless compression methods and then introduce two lossy compression methods. Students emerge from this study competent in a wide range of techniques. The authors' presentation is highly practical but includes some important proofs either in the text or in the exercises so instructors can if they choose place more emphasis on the mathematics. Introduction to Information Theory and Data Compression Second Edition is ideally suited for an upper-level or graduate course for students in mathematics engineering and computer science. Features:Expanded discussion of the historical and theoretical basis of information theory that builds a firm intuitive grasp of the subjectReorganization of theoretical results along with new exercises ranging from the routine to the more difficult that reinforce students' ability to apply the definitions and results in specific situations. Simplified treatment of the algorithm(s) of Gallager and KnuthDiscussion of the information rate of a code and the trade-off between error correction and information rateTreatment of probabilistic finite state source automata including basic resul

GBP 59.99
1

Clinical Trial Methodology

Clinical Trial Methodology

Now viewed as its own scientific discipline clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors’ courses on the subject as well as the first author’s more than 30 years working in the pharmaceutical industry Clinical Trial Methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research. From ethical issues and sample size considerations to adaptive design procedures and statistical analysis the book first covers the methodology that spans every clinical trial regardless of the area of application. Crucial to the generic drug industry bioequivalence clinical trials are then discussed. The authors describe a parallel bioequivalence clinical trial of six formulations incorporating group sequential procedures that permit sample size re-estimation. The final chapters incorporate real-world case studies of clinical trials from the authors’ own experiences. These examples include a landmark Phase III clinical trial involving the treatment of duodenal ulcers and Phase III clinical trials that contributed to the first drug approved for the treatment of Alzheimer’s disease. Aided by the U. S. FDA the U. S. National Institutes of Health the pharmaceutical industry and academia the area of clinical trial methodology has evolved over the last six decades into a scientific discipline. This guide explores the processes essential for developing and conducting a quality clinical trial protocol and providing quality data collection biostatistical analyses and a clinical study report all while maintaining the highest standards of ethics and excellence.

GBP 44.99
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