Statistical Issues

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 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.

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.

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.

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.

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