Statistical Issues

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Statistical Issues in Drug Development

Author : Stephen S. Senn
Publisher : John Wiley & Sons
Page : 523 pages
File Size : 43,5 Mb
Release : 2008-02-28
Category : Medical
ISBN : 0470723572

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Statistical Issues in Drug Development by Stephen S. Senn Pdf

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.

Statistical Issues in Drug Development

Author : Stephen S. Senn
Publisher : John Wiley & Sons
Page : 84 pages
File Size : 53,8 Mb
Release : 2021-08-23
Category : Medical
ISBN : 9781119238577

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Statistical Issues in Drug Development by Stephen S. Senn Pdf

Statistical Issues in Drug Development The revised third edition of Statistical Issues in Drug Development delivers an insightful treatment of the intersection between statistics and the life sciences. The book offers readers new discussions of crucial topics, including cluster randomization, historical controls, responder analysis, studies in children, post-hoc tests, estimands, publication bias, the replication crisis, and many more. This work presents the major statistical issues in drug development in a way that is accessible and comprehensible to life scientists working in the field, and takes pains not to gloss over significant disagreements in the field of statistics, while encouraging communication between the statistical and life sciences disciplines. In addition to new material on topics like invalid inversion, severity, random effects in network meta-analysis, and explained variation, readers will benefit from the inclusion of: A thorough introduction to basic topics in drug development and statistics, including the role played by statistics in drug development An exploration of the four views of statistics in drug development, including the historical, methodological, technical, and professional An examination of debatable and controversial topics in drug development, including the allocation of treatments to patients in clinical trials, baselines and covariate information, and the measurement of treatment effects Perfect for life scientists and other professionals working in the field of drug development, Statistical Issues in Drug Development is the ideal resource for anyone seeking a one-stop reference to enhance their understanding of the use of statistics during drug development.

Statistical Issues in Allocating Funds by Formula

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Formula Allocations
Publisher : National Academies Press
Page : 162 pages
File Size : 48,9 Mb
Release : 2003-02-24
Category : Political Science
ISBN : 9780309087100

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Statistical Issues in Allocating Funds by Formula by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Formula Allocations Pdf

In 2000, the federal government distributed over $260 billion of funding to state and local governments via 180 formula programs. These programs promote a wide spectrum of economic and social objectives, such as improving educational outcomes and increasing accessibility to medical care, and many are designed to compensate for differences in fiscal capacity that affect governments' abilities to address identified needs. Large amounts of state revenues are also distributed through formula allocation programs to counties, cities, and other jurisdictions. Statistical Issues in Allocating Funds by Formula identifies key issues concerning the design and use of these formulas and advances recommendations for improving the process. In addition to the more narrow issues relating to formula design and input data, the book discusses broader issues created by the interaction of the political process and the use of formulas to allocate funds. Statistical Issues in Allocating Funds by Formula is only up-to-date guide for policymakers who design fund allocation programs. Congress members who are crafting legislation for these programs and federal employees who are in charge of distributing the funds will find this book indispensable.

Statistical Issues in Drug Research and Development

Author : Karl E. Peace
Publisher : CRC Press
Page : 390 pages
File Size : 53,6 Mb
Release : 1989-12-11
Category : Mathematics
ISBN : 0824782909

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Statistical Issues in Drug Research and Development by Karl E. Peace Pdf

This book is a compilation of topics addressed by the ASA Biopharmaceutical Section work groups, including the etiology and evolution of the work groups, the work group guidelines and structure, and the statistical issues associated with clinical trials in clinical drug development programs.

Statistical Issues in Machine Learning

Author : Carolin Strobl
Publisher : Cuvillier Verlag
Page : 203 pages
File Size : 51,5 Mb
Release : 2008
Category : Electronic
ISBN : 9783867276610

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Statistical Issues in Machine Learning by Carolin Strobl Pdf

Numerical Issues in Statistical Computing for the Social Scientist

Author : Micah Altman,Jeff Gill,Michael P. McDonald
Publisher : John Wiley & Sons
Page : 323 pages
File Size : 55,8 Mb
Release : 2004-02-15
Category : Mathematics
ISBN : 9780471475743

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Numerical Issues in Statistical Computing for the Social Scientist by Micah Altman,Jeff Gill,Michael P. McDonald Pdf

At last—a social scientist's guide through the pitfalls ofmodern statistical computing Addressing the current deficiency in the literature onstatistical methods as they apply to the social and behavioralsciences, Numerical Issues in Statistical Computing for the SocialScientist seeks to provide readers with a unique practicalguidebook to the numerical methods underlying computerizedstatistical calculations specific to these fields. The authorsdemonstrate that knowledge of these numerical methods and how theyare used in statistical packages is essential for making accurateinferences. With the aid of key contributors from both the socialand behavioral sciences, the authors have assembled a rich set ofinterrelated chapters designed to guide empirical social scientiststhrough the potential minefield of modern statisticalcomputing. Uniquely accessible and abounding in modern-day tools, tricks,and advice, the text successfully bridges the gap between thecurrent level of social science methodology and the moresophisticated technical coverage usually associated with thestatistical field. Highlights include: A focus on problems occurring in maximum likelihoodestimation Integrated examples of statistical computing (using softwarepackages such as the SAS, Gauss, Splus, R, Stata, LIMDEP, SPSS,WinBUGS, and MATLAB®) A guide to choosing accurate statistical packages Discussions of a multitude of computationally intensivestatistical approaches such as ecological inference, Markov chainMonte Carlo, and spatial regression analysis Emphasis on specific numerical problems, statisticalprocedures, and their applications in the field Replications and re-analysis of published social scienceresearch, using innovative numerical methods Key numerical estimation issues along with the means ofavoiding common pitfalls A related Web site includes test data for use in demonstratingnumerical problems, code for applying the original methodsdescribed in the book, and an online bibliography of Web resourcesfor the statistical computation Designed as an independent research tool, a professionalreference, or a classroom supplement, the book presents awell-thought-out treatment of a complex and multifaceted field.

Controversial Statistical Issues in Clinical Trials

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 598 pages
File Size : 47,6 Mb
Release : 2016-04-19
Category : Health & Fitness
ISBN : 9781439849620

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Controversial Statistical Issues in Clinical Trials by Shein-Chung Chow Pdf

In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials cov

Statistical Topics in Health Economics and Outcomes Research

Author : Demissie Alemayehu, PhD,Joseph C. Cappelleri, PhD,Birol Emir, PhD,Kelly H. Zou, PhD, Pstat
Publisher : CRC Press
Page : 210 pages
File Size : 44,8 Mb
Release : 2017-11-22
Category : Mathematics
ISBN : 9781498781886

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Statistical Topics in Health Economics and Outcomes Research by Demissie Alemayehu, PhD,Joseph C. Cappelleri, PhD,Birol Emir, PhD,Kelly H. Zou, PhD, Pstat Pdf

With ever-rising healthcare costs, evidence generation through Health Economics and Outcomes Research (HEOR) plays an increasingly important role in decision-making about the allocation of resources. Accordingly, it is now customary for health technology assessment and reimbursement agencies to request for HEOR evidence, in addition to data from clinical trials, to inform decisions about patient access to new treatment options. While there is a great deal of literature on HEOR, there is a need for a volume that presents a coherent and unified review of the major issues that arise in application, especially from a statistical perspective. Statistical Topics in Health Economics and Outcomes Research fulfils that need by presenting an overview of the key analytical issues and best practice. Special attention is paid to key assumptions and other salient features of statistical methods customarily used in the area, and appropriate and relatively comprehensive references are made to emerging trends. The content of the book is purposefully designed to be accessible to readers with basic quantitative backgrounds, while providing an in-depth coverage of relatively complex statistical issues. The book will make a very useful reference for researchers in the pharmaceutical industry, academia, and research institutions involved with HEOR studies. The targeted readers may include statisticians, data scientists, epidemiologists, outcomes researchers, health economists, and healthcare policy and decision-makers.

Statistics Done Wrong

Author : Alex Reinhart
Publisher : No Starch Press
Page : 177 pages
File Size : 45,7 Mb
Release : 2015-03-01
Category : Mathematics
ISBN : 9781593276201

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Statistics Done Wrong by Alex Reinhart Pdf

Scientific progress depends on good research, and good research needs good statistics. But statistical analysis is tricky to get right, even for the best and brightest of us. You'd be surprised how many scientists are doing it wrong. Statistics Done Wrong is a pithy, essential guide to statistical blunders in modern science that will show you how to keep your research blunder-free. You'll examine embarrassing errors and omissions in recent research, learn about the misconceptions and scientific politics that allow these mistakes to happen, and begin your quest to reform the way you and your peers do statistics. You'll find advice on: –Asking the right question, designing the right experiment, choosing the right statistical analysis, and sticking to the plan –How to think about p values, significance, insignificance, confidence intervals, and regression –Choosing the right sample size and avoiding false positives –Reporting your analysis and publishing your data and source code –Procedures to follow, precautions to take, and analytical software that can help Scientists: Read this concise, powerful guide to help you produce statistically sound research. Statisticians: Give this book to everyone you know. The first step toward statistics done right is Statistics Done Wrong.

Statistical Topics and Stochastic Models for Dependent Data with Applications

Author : Vlad Stefan Barbu,Nicolas Vergne
Publisher : John Wiley & Sons
Page : 288 pages
File Size : 51,6 Mb
Release : 2020-12-03
Category : Mathematics
ISBN : 9781786306036

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Statistical Topics and Stochastic Models for Dependent Data with Applications by Vlad Stefan Barbu,Nicolas Vergne Pdf

This book is a collective volume authored by leading scientists in the field of stochastic modelling, associated statistical topics and corresponding applications. The main classes of stochastic processes for dependent data investigated throughout this book are Markov, semi-Markov, autoregressive and piecewise deterministic Markov models. The material is divided into three parts corresponding to: (i) Markov and semi-Markov processes, (ii) autoregressive processes and (iii) techniques based on divergence measures and entropies. A special attention is payed to applications in reliability, survival analysis and related fields.

Statistical Issues in Rodent Bioassays

Author : Tony Hai Lin
Publisher : Unknown
Page : 114 pages
File Size : 55,9 Mb
Release : 1994
Category : Electronic
ISBN : UCAL:C3386495

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Statistical Issues in Rodent Bioassays by Tony Hai Lin Pdf

Statistical Abstract of the United States

Author : Anonim
Publisher : Unknown
Page : 982 pages
File Size : 46,6 Mb
Release : 1988
Category : United States
ISBN : PURD:32754061464289

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Statistical Abstract of the United States by Anonim Pdf

Nonparametric Statistical Methods and Related Topics

Author : J Jiang,G G Roussas,F J Samaniego
Publisher : World Scientific
Page : 480 pages
File Size : 55,5 Mb
Release : 2011-09-16
Category : Mathematics
ISBN : 9789814458177

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Nonparametric Statistical Methods and Related Topics by J Jiang,G G Roussas,F J Samaniego Pdf

This volume consists of 22 research papers by leading researchers in Probability and Statistics. Many of the papers are focused on themes that Professor Bhattacharya has published on research. Topics of special interest include nonparametric inference, nonparametric curve fitting, linear model theory, Bayesian nonparametrics, change point problems, time series analysis and asymptotic theory. This volume presents state-of-the-art research in statistical theory, with an emphasis on nonparametric inference, linear model theory, time series analysis and asymptotic theory. It will serve as a valuable reference to the statistics research community as well as to practitioners who utilize methodology in these areas of emphasis. Contents:Review Papers:On the Scholarly Work of P K Bhattacharya (P Hall & F J Samaniego)The Propensity Score and Its Role in Causal Inference (C Drake & T Loux)Recent Tests for Symmetry with Multivariate and Structured Data: A Review (S G Meintanis & J Ngatchou-Wandji)Papers on General Nonparametric Inference:On Robust Versions of Classical Tests with Dependent Data (J Jiang)Density Estimation by Sampling from Stationary Continuous Time Parameter Associated Processes (G G Roussas & D Bhattacharya)A Short Proof of the Feigin–Tweedie Theorem on the Existence of the Mean Functional of a Dirichlet Process (J Sethuraman)Max–Min Bernstein Polynomial Estimation of a Discontinuity in Distribution (K-S Song)U-Statistics Based on Higher-Order Spacings (D D Tung & S R Jammalamadaka)Nonparametric Models for Non-Gaussian Longitudinal Data (N Zhang, H-G Müller and J-L Wang)Papers on Aspects of Linear or Generalized Linear Models:Better Residuals (R Beran)The Use of Peters–Belson Regression in Legal Cases (E Bura, J L Gastwirth & H Hikawa)On a Hybrid Approach to Parametric and Nonparametric Regression (P Burman & P Chaudhuri)Nonparametric Regression Models with Integrated Covariates (Z Cai)A Dynamic Test for Misspecification of a Linear Model (M P McAssey & F Hsieh) Component Decomposition of the Basic Martingale (W Stute)Papers on Time Series Analysis:moothing Using Blockwise Least Squares Fitting (A Aue & T C M Lee)Some Recent Advances in Semiparametric Estimation of the GARCH Model (J Di & A Gangopadhyay)Extreme Dependence in Multivariate Time Series: A Review (R Sen & Z Tan)Dynamic Mixed Models for Irregularly Observed Water Quality Data (R H Shumway)Papers on Asymptotic Theory:Asymptotic Behavior of the Kernel Density Estimators for Nonstationary Dependent Random Variables with Binned Data (J-F Lenain, M Harel & M L Puri)Convergence Rates of an Improved Isotonic Regression Estimator (H Mukerjee)Asymptotic Distribution of the Smallest Eigenvalue of Wishart(N,n) When N,n → ∞ Such That N/n → 0 (D Paul)Curriculum Vitae:Curriculum Vitae of Prodyot K Bhattacharya Readership: Graduate students and researchers in nonparametric statistics and stochastic analysis. Keywords:Nonparametric Inference;Nonparametric Curve Fitting;Regression Analysis;Bayesian Nonparametrics;Change Point Problems;Asymptotic Theory;Stochastic ProcessesKey Features:New research in key areas of interest for statistical researchers and practitionersContributions by prominent statisticiansReview articles on the research contributions of P K Bhattacharya, on the area of causal inference and on nonparametric tests for symmetry

The Evaluation of Forensic DNA Evidence

Author : National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Committee on DNA Forensic Science: An Update
Publisher : National Academies Press
Page : 271 pages
File Size : 48,7 Mb
Release : 1997-01-12
Category : Science
ISBN : 9780309121941

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The Evaluation of Forensic DNA Evidence by National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Committee on DNA Forensic Science: An Update Pdf

In 1992 the National Research Council issued DNA Technology in Forensic Science, a book that documented the state of the art in this emerging field. Recently, this volume was brought to worldwide attention in the murder trial of celebrity O. J. Simpson. The Evaluation of Forensic DNA Evidence reports on developments in population genetics and statistics since the original volume was published. The committee comments on statements in the original book that proved controversial or that have been misapplied in the courts. This volume offers recommendations for handling DNA samples, performing calculations, and other aspects of using DNA as a forensic toolâ€"modifying some recommendations presented in the 1992 volume. The update addresses two major areas: Determination of DNA profiles. The committee considers how laboratory errors (particularly false matches) can arise, how errors might be reduced, and how to take into account the fact that the error rate can never be reduced to zero. Interpretation of a finding that the DNA profile of a suspect or victim matches the evidence DNA. The committee addresses controversies in population genetics, exploring the problems that arise from the mixture of groups and subgroups in the American population and how this substructure can be accounted for in calculating frequencies. This volume examines statistical issues in interpreting frequencies as probabilities, including adjustments when a suspect is found through a database search. The committee includes a detailed discussion of what its recommendations would mean in the courtroom, with numerous case citations. By resolving several remaining issues in the evaluation of this increasingly important area of forensic evidence, this technical update will be important to forensic scientists and population geneticistsâ€"and helpful to attorneys, judges, and others who need to understand DNA and the law. Anyone working in laboratories and in the courts or anyone studying this issue should own this book.