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It offers   A common language and unifying framework along with the technical details and practical guidance to help statisticians meet the challenges   A thorough treatment of intercurrent events (ICEs), i.e., postrandomization events that confound interpretation of outcomes and five strategies for ICEs in ICH E9 (R1)   Details on how estimands, integrated into a principled study development process, lay a foundation for coherent specification of trial design, conduct, and analysis needed to overcome the issues caused by ICEs:   A perspective on the role of the intention-to-treat principle   Examples and case studies from various areas   Example code in SAS and R   A connection with causal inference   Implications and methods for analysis of longitudinal trials with missing data  Together, the authors have offered the readers their ample expertise in clinical trial design and analysis, from an industrial and academic perspective.","brand":"WoB","offers":[{"title":"GB \/ NEW \/ GARDNERS","offer_id":50697636053265,"sku":"NGR9781138592506","price":0.0,"currency_code":"GBP","in_stock":false},{"title":"US \/ NEW \/ INGRAM","offer_id":51232224674065,"sku":"NIN9781138592506","price":0.0,"currency_code":"GBP","in_stock":true},{"title":"GB \/ NEW \/ INGRAM","offer_id":52144659005713,"sku":"NLS9781138592506","price":0.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0784\/4072\/6801\/files\/1138592501.jpg?v=1750823535"},{"product_id":"real-world-evidence-in-drug-development-and-evaluation-book-harry-yang-9780367026219","title":"Real-World Evidence in Drug Development and Evaluation","description":"Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. 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Clarifies controversial statistical issues in regulatory review and approval accurately and reliably.      Makes recommendations to evaluate rare diseases regulatory submissions.      Proposes innovative study designs and statistical methods for rare diseases drug development, including n-of-1 trial design, adaptive trial design, and master protocols like platform trials.      Provides insight regarding current regulatory guidance on rare diseases drug development like gene therapy.","brand":"WoB","offers":[{"title":"GB \/ NEW \/ GARDNERS","offer_id":50697817030929,"sku":"NGR9780367502102","price":0.0,"currency_code":"GBP","in_stock":false},{"title":"US \/ NEW \/ INGRAM","offer_id":51119164195089,"sku":"NIN9780367502102","price":0.0,"currency_code":"GBP","in_stock":false},{"title":"GB \/ NEW \/ INGRAM","offer_id":52470819160337,"sku":"NLS9780367502102","price":0.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0784\/4072\/6801\/files\/0367502100.jpg?v=1750739385"},{"product_id":"roc-analysis-for-classification-and-prediction-in-practice-book-christos-nakas-9781482233704","title":"ROC Analysis for Classification and Prediction in Practice","description":"This book presents a unified and up-to-date introduction to ROC methodologies, covering both diagnosis (classification) and prediction. 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Features:    Functional and systems mapping models to characterize the genetic architecture of multiple medication processes  Statistical methods for analyzing informative missing data in pharmacogenetic association studies  Functional graph theory of inferring genetic interaction networks from association data  Leveraging the concept of epistasis to capture its bidirectional, signed and weighted properties  Modeling gene-induced cell-cell crosstalk and its impact on drug response  A graph model of drug-drug interactions in combination therapies  Critical methodological issues to improve pharmacogenomic research as the cornerstone of precision medicine   This book is suitable for graduate students and researchers in the fields of biology, medicine, bioinformatics and drug design and delivery who are interested in statistical and computational modelling of biological processes and systems. It may also serve as a major reference for applied mathematicians, computer scientists, and statisticians who attempt to develop algorithmic tools for genetic mapping, systems pharmacogenomics and systems biology. It can be used as both a textbook and research reference. Professionals in pharmaceutical sectors who design drugs and clinical doctors who deliver drugs will also find it useful.","brand":"WoB","offers":[{"title":"GB \/ NEW \/ GARDNERS","offer_id":50697861267729,"sku":"NGR9781482219456","price":0.0,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0784\/4072\/6801\/files\/148221945X.jpg?v=1750827107"},{"product_id":"sample-size-calculations-in-clinical-research-book-shein-chung-chow-9780367657765","title":"Sample Size Calculations in Clinical Research","description":"Praise for the Second Edition:  \"… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study.\" -Biometrics    \"This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered …\" – Journal of the Royal Statistical Society    Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation.    Features:            Compares the relative merits and disadvantages of statistical methods for sample size calculations          Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages          Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health          Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches        This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.","brand":"WoB","offers":[{"title":"- \/ - \/ -","offer_id":50697860382993,"sku":"","price":0.0,"currency_code":"GBP","in_stock":true},{"title":"GB \/ NEW \/ GARDNERS","offer_id":50697863004433,"sku":"NGR9780367657765","price":0.0,"currency_code":"GBP","in_stock":false},{"title":"GB \/ NEW \/ INGRAM","offer_id":52137080520977,"sku":"NLS9780367657765","price":0.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0784\/4072\/6801\/files\/0367657767.jpg?v=1750941544"},{"product_id":"applied-meta-analysis-with-r-and-stata-book-ding-geng-chen-9780367183837","title":"Applied Meta-Analysis with R and Stata","description":"Review of the First Edition:  The authors strive to reduce theory to a minimum, which makes it a self-learning text that is comprehensible for biologists, physicians, etc. who lack an advanced mathematics background. 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What’s New in the Second Edition:         Adds Stata programs along with the R programs for meta-analysis      Updates all the statistical meta-analyses with R\/Stata programs      Covers fixed-effects and random-effects MA, meta-regression, MA with rare-event, and MA-IPD vs MA-SS      Adds five new chapters on multivariate MA, publication bias, missing data in MA, MA in evaluating diagnostic accuracy, and network MA  Suitable as a graduate-level text for a meta-data analysis course, the book is also a valuable reference for practitioners and biostatisticians (even those with little or no experience in using R or Stata) in public health, medical research, governmental agencies, and the pharmaceutical industry.","brand":"WoB","offers":[{"title":"- \/ - \/ -","offer_id":50697877389585,"sku":"","price":0.0,"currency_code":"GBP","in_stock":true},{"title":"GB \/ NEW \/ GARDNERS","offer_id":50697880928529,"sku":"NGR9780367183837","price":0.0,"currency_code":"GBP","in_stock":false},{"title":"GB \/ NEW \/ INGRAM","offer_id":52130143043857,"sku":"NLS9780367183837","price":0.0,"currency_code":"GBP","in_stock":true},{"title":"US \/ NEW \/ INGRAM","offer_id":52849018831121,"sku":"NIN9780367183837","price":0.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0784\/4072\/6801\/files\/0367183838.jpg?v=1750813453"},{"product_id":"bayesian-analysis-with-r-for-drug-development-book-harry-yang-9781032177861","title":"Bayesian Analysis with R for Drug Development","description":"Drug development is an iterative process. 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Features         Provides a single source of information on Bayesian statistics for drug development      Covers a wide spectrum of pre-clinical, clinical, and CMC topics       Demonstrates proper Bayesian applications using real-life examples      Includes easy-to-follow R code with Bayesian Markov Chain Monte Carlo performed in both JAGS and Stan Bayesian software platforms      Offers sufficient background for each problem and detailed description of solutions suitable for practitioners with limited Bayesian knowledge  Harry Yang, Ph.D., is Senior Director and Head of Statistical Sciences at AstraZeneca. He has 24 years of experience across all aspects of drug research and development and extensive global regulatory experiences. He has published 6 statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects, including 15 joint statistical works with Dr. Novick. He is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP as well as Peking University.  Steven Novick, Ph.D., is Director of Statistical Sciences at AstraZeneca. He has extensively contributed statistical methods to the biopharmaceutical literature. Novick is a skilled Bayesian computer programmer and is frequently invited to speak at conferences, having developed and taught courses in several areas, including drug-combination analysis and Bayesian methods in clinical areas. 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What’s New in the Second Edition:         Adds Stata programs along with the R programs for meta-analysis      Updates all the statistical meta-analyses with R\/Stata programs      Covers fixed-effects and random-effects MA, meta-regression, MA with rare-event, and MA-IPD vs MA-SS      Adds five new chapters on multivariate MA, publication bias, missing data in MA, MA in evaluating diagnostic accuracy, and network MA  Suitable as a graduate-level text for a meta-data analysis course, the book is also a valuable reference for practitioners and biostatisticians (even those with little or no experience in using R or Stata) in public health, medical research, governmental agencies, and the pharmaceutical industry.","brand":"WoB","offers":[{"title":"GB \/ NEW \/ GARDNERS","offer_id":50698409672977,"sku":"NGR9780367709341","price":0.0,"currency_code":"GBP","in_stock":false},{"title":"US \/ NEW \/ INGRAM","offer_id":51001672237329,"sku":"NIN9780367709341","price":0.0,"currency_code":"GBP","in_stock":true},{"title":"GB \/ NEW \/ INGRAM","offer_id":52432636444945,"sku":"NLS9780367709341","price":0.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0784\/4072\/6801\/files\/0367709341.jpg?v=1750941618"},{"product_id":"real-world-evidence-in-drug-development-and-evaluation-book-harry-yang-9780367637019","title":"Real-World Evidence in Drug Development and Evaluation","description":"Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. 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However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs.   Features:         Regulatory and statistical interactions throughout the drug development continuum      The critical role of the statistician in relation to the changing regulatory and healthcare landscapes       Statistical issues that commonly arise in the course of drug development and regulatory interactions      Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities   The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors’ decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.","brand":"WoB","offers":[{"title":"GB \/ NEW \/ GARDNERS","offer_id":50698428285201,"sku":"NGR9780367608286","price":0.0,"currency_code":"GBP","in_stock":false},{"title":"US \/ NEW \/ INGRAM","offer_id":51284815937809,"sku":"NIN9780367608286","price":0.0,"currency_code":"GBP","in_stock":false},{"title":"GB \/ NEW \/ INGRAM","offer_id":52483811508497,"sku":"NLS9780367608286","price":0.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0784\/4072\/6801\/files\/0367608286.jpg?v=1750909497"},{"product_id":"medical-risk-prediction-models-book-thomas-a-gerds-9780367673734","title":"Medical Risk Prediction Models","description":"Medical Risk Prediction Models: With Ties to Machine Learning is a hands-on book for clinicians, epidemiologists, and professional statisticians who need to make or evaluate a statistical prediction model based on data. The subject of the book is the patient’s individualized probability of a medical event within a given time horizon. Gerds and Kattan describe the mathematical details of making and evaluating a statistical prediction model in a highly pedagogical manner while avoiding mathematical notation. Read this book when you are in doubt about whether a Cox regression model predicts better than a random survival forest.  Features:      All you need to know to correctly make an online risk calculator from scratch.         Discrimination, calibration, and predictive performance with censored data and competing risks.         R-code and illustrative examples.         Interpretation of prediction performance via benchmarks.         Comparison and combination of rival modeling strategies via cross-validation.","brand":"WoB","offers":[{"title":"GB \/ NEW \/ GARDNERS","offer_id":50698446242065,"sku":"NGR9780367673734","price":0.0,"currency_code":"GBP","in_stock":true},{"title":"US \/ NEW \/ INGRAM","offer_id":51001635340561,"sku":"NIN9780367673734","price":0.0,"currency_code":"GBP","in_stock":false},{"title":"GB \/ NEW \/ INGRAM","offer_id":52452250910993,"sku":"NLS9780367673734","price":0.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0784\/4072\/6801\/files\/0367673738.jpg?v=1751006031"},{"product_id":"cure-models-book-yingwei-peng-9780367690748","title":"Cure Models","description":"Cure Models: Methods, Applications and Implementation is the first book in the last 25 years that provides a comprehensive and systematic introduction to the basics of modern cure models, including estimation, inference, and software. This book is useful for statistical researchers and graduate students, and practitioners in other disciplines to have a thorough review of modern cure model methodology and to seek appropriate cure models in applications. The prerequisites of this book include some basic knowledge of statistical modeling, survival models, and R and SAS for data analysis.  The book features real-world examples from clinical trials and population-based studies and a detailed introduction to R packages, SAS macros, and WinBUGS programs to fit some cure models. The main topics covered include         the foundation of statistical estimation and inference of cure models for independent and right-censored survival data,      cure modeling for multivariate, recurrent-event, and competing-risks survival data, and joint modeling with longitudinal data,      statistical testing for the existence and difference of cure rates and sufficient follow-up,      new developments in Bayesian cure models,      applications of cure models in public health research and clinical trials.","brand":"WoB","offers":[{"title":"GB \/ NEW \/ GARDNERS","offer_id":50698482417937,"sku":"NGR9780367690748","price":0.0,"currency_code":"GBP","in_stock":false},{"title":"US \/ NEW \/ INGRAM","offer_id":51284838056209,"sku":"NIN9780367690748","price":0.0,"currency_code":"GBP","in_stock":false},{"title":"GB \/ NEW \/ INGRAM","offer_id":52402456658193,"sku":"NLS9780367690748","price":0.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0784\/4072\/6801\/files\/0367690748.jpg?v=1750878239"},{"product_id":"statistical-methods-in-health-disparity-research-book-j-sunil-rao-9780367635121","title":"Statistical Methods in Health Disparity Research","description":"A health disparity refers to a higher burden of illness, injury, disability, or mortality experienced by one group relative to others attributable to multiple factors including socioeconomic status, environmental factors, insufficient access to health care, individual risk factors, and behaviors and inequalities in education. 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It will also be useful to many quantitative modelers in genetics, biology, sociology, and epidemiology.","brand":"WoB","offers":[{"title":"GB \/ NEW \/ GARDNERS","offer_id":50698588684561,"sku":"NGR9780367635121","price":0.0,"currency_code":"GBP","in_stock":true},{"title":"US \/ NEW \/ INGRAM","offer_id":51001626067217,"sku":"NIN9780367635121","price":0.0,"currency_code":"GBP","in_stock":true},{"title":"GB \/ NEW \/ INGRAM","offer_id":52521420423441,"sku":"NLS9780367635121","price":0.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0784\/4072\/6801\/files\/0367635127.jpg?v=1751324660"},{"product_id":"signal-detection-for-medical-scientists-book-ram-tiwari-9781032016344","title":"Signal Detection for Medical Scientists","description":"Signal Detection for Medical Scientists: Likelihood Ratio Based Test-Based Methodology presents the data mining techniques with focus on likelihood ratio test (LRT) based methods for signal detection. 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