design and analysis of clinical trials concepts and methodologies wiley series in probability and statistics

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Design And Analysis Of Clinical Trials

Author : Shein-Chung Chow
ISBN : 9780471473299
Genre : Mathematics
File Size : 60. 71 MB
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Design And Analysis Of Clinical Trials

Author : Shein-Chung Chow
ISBN : UOM:39015057654058
Genre : Mathematics
File Size : 72. 42 MB
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Presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. Emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references.

Design And Analysis Of Clinical Trials

Author : Shein-Chung Chow
ISBN : 047113404X
Genre : Mathematics
File Size : 45. 64 MB
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Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references-280 of them new to the Second Edition-to the literature. Design and Analysis of Clinical Trials, Second Edition will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research.

Clinical Trials

Author : Steven Piantadosi
ISBN : 9781118959213
Genre : Mathematics
File Size : 45. 74 MB
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Presents elements of clinical trial methods that are essential in planning, designing, conducting, analyzing, and interpreting clinical trials with the goal of improving the evidence derived from these important studies This Third Edition builds on the text’s reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials. Readers will encounter the principles of design for various types of clinical trials, and are then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides common sense solutions. All stages of therapeutic development are discussed in detail, and the methods are not restricted to a single clinical application area. The authors bases current revisions and updates on his own experience, classroom instruction, and feedback from teachers and medical and statistical professionals involved in clinical trials. The Third Edition greatly expands its coverage, ranging from statistical principles to new and provocative topics, including alternative medicine and ethics, middle development, comparative studies, and adaptive designs. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First and Second Editions will discover revamped exercise sets; an updated and extensive reference section; new material on endpoints and the developmental pipeline, among others; and revisions of numerous sections. In addition, this book: • Features accessible and broad coverage of statistical design methods—the crucial building blocks of clinical trials and medical research -- now complete with new chapters on overall development, middle development, comparative studies, and adaptive designs • Teaches readers to design clinical trials that produce valid qualitative results backed by rigorous statistical methods • Contains an introduction and summary in each chapter to reinforce key points • Includes discussion questions to stimulate critical thinking and help readers understand how they can apply their newfound knowledge • Provides extensive references to direct readers to the most recent literature, and there are numerous new or revised exercises throughout the book Clinical Trials: A Methodologic Perspective, Third Edition is a textbook accessible to advanced undergraduate students in the quantitative sciences, graduate students in public health and the life sciences, physicians training in clinical research methods, and biostatisticians and epidemiologists. Steven Piantadosi, MD, PhD, is the Phase One Foundation Distinguished Chair and Director of the Samuel Oschin Cancer Institute, and Professor of Medicine at Cedars-Sinai Medical Center in Los Angeles, California. Dr. Piantadosi is one of the world’s leading experts in the design and analysis of clinical trials for cancer research. He has taught clinical trials methods extensively in formal courses and short venues. He has advised numerous academic programs and collaborations nationally regarding clinical trial design and conduct, and has served on external advisory boards for the National Institutes of Health and other prominent cancer programs and centers. The author of more than 260 peer-reviewed scientific articles, Dr. Piantadosi has published extensively on research results, clinical applications, and trial methodology. While his papers have contributed to many areas of oncology, he has also collaborated on diverse studies outside oncology including lung disease and degenerative neurological disease.

Introduction To Statistical Methods For Clinical Trials

Author : Thomas D. Cook
ISBN : 9781584880271
Genre : Mathematics
File Size : 53. 88 MB
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Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.

Statistical Design And Analysis Of Clinical Trials

Author : Weichung Joe Shih
ISBN : 9781482250503
Genre : Mathematics
File Size : 71. 72 MB
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Statistical Design and Analysis of Clinical Trials: Principles and Methods concentrates on the biostatistics component of clinical trials. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 15 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. Teach Your Students How to Design, Monitor, and Analyze Clinical Trials The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, explain the concept of different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. Turn Your Students into Better Clinical Trial Investigators This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students a multidisciplinary understanding of the concepts and techniques involved in designing and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

Biostatistics

Author : Gerald van Belle
ISBN : 9780471602354
Genre : Medical
File Size : 30. 96 MB
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A respected introduction to biostatistics, thoroughly updated and revised The first edition of Biostatistics: A Methodology for the Health Sciences has served professionals and students alike as a leading resource for learning how to apply statistical methods to the biomedical sciences. This substantially revised Second Edition brings the book into the twenty-first century for today’s aspiring and practicing medical scientist. This versatile reference provides a wide-ranging look at basic and advanced biostatistical concepts and methods in a format calibrated to individual interests and levels of proficiency. Written with an eye toward the use of computer applications, the book examines the design of medical studies, descriptive statistics, and introductory ideas of probability theory and statistical inference; explores more advanced statistical methods; and illustrates important current uses of biostatistics. New to this edition are discussions of Longitudinal data analysis Randomized clinical trials Bayesian statistics GEE The bootstrap method Enhanced by a companion Web site providing data sets, selected problems and solutions, and examples from such current topics as HIV/AIDS, this is a thoroughly current, comprehensive introduction to the field.

Biostatistics Decoded

Author : A. Gouveia Oliveira
ISBN : 9781118670798
Genre : Medical
File Size : 63. 64 MB
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Study design and statistical methodology are two important concerns for the clinical researcher. This book sets out to address both issues in a clear and concise manner. The presentation of statistical theory starts from basic concepts, such as the properties of means and variances, the properties of the Normal distribution and the Central Limit Theorem and leads to more advanced topics such as maximum likelihood estimation, inverse variance and stepwise regression as well as, time-to-event, and event-count methods. Furthermore, this book explores sampling methods, study design and statistical methods and is organized according to the areas of application of each of the statistical methods and the corresponding study designs. Illustrations, working examples, computer simulations and geometrical approaches, rather than mathematical expressions and formulae, are used throughout the book to explain every statistical method. Biostatisticians and researchers in the medical and pharmaceutical industry who need guidance on the design and analyis of medical research will find this book useful as well as graduate students of statistics and mathematics with an interest in biostatistics. Biostatistics Decoded: Provides clear explanations of key statistical concepts with a firm emphasis on practical aspects of design and analysis of medical research. Features worked examples to illustrate each statistical method using computer simulations and geometrical approaches, rather than mathematical expressions and formulae. Explores the main types of clinical research studies, such as, descriptive, analytical and experimental studies. Addresses advanced modeling techniques such as interaction analysis and encoding by reference and polynomial regression.

Sample Size Calculations In Clinical Research

Author : Shein-Chung Chow
ISBN : 9780824748234
Genre : Mathematics
File Size : 75. 99 MB
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Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical research and development, Sample Size Calculation in Clinical Research explores the causes of discrepancies and how to avoid them. This volume provides formulas and procedures for determination of sample size required not only for testing equality, but also for testing non-inferiority/superiority, and equivalence (similarity) based on both untransformed (raw) data and log-transformed data under a parallel-group design or a crossover design with equal or unequal ratio of treatment allocations. It contains a comprehensive and unified presentation of statistical procedures for sample size calculation that are commonly employed at various phases of clinical development. Each chapter includes, whenever possible, real examples of clinical studies from therapeutic areas such as cardiovascular, central nervous system, anti-infective, oncology, and women's health to demonstrate the clinical and statistical concepts, interpretations, and their relationships and interactions. The book highlights statistical procedures for sample size calculation and justification that are commonly employed in clinical research and development. It provides clear, illustrated explanations of how the derived formulas and/or statistical procedures can be used.

Sample Size Determination And Power

Author : Thomas P. Ryan
ISBN : 9781118439227
Genre : Medical
File Size : 36. 13 MB
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A comprehensive approach to sample size determination and power with applications for a variety of fields Sample Size Determination and Power features a modern introduction to the applicability of sample size determination and provides a variety of discussions on broad topics including epidemiology, microarrays, survival analysis and reliability, design of experiments, regression, and confidence intervals. The book distinctively merges applications from numerous fields such as statistics, biostatistics, the health sciences, and engineering in order to provide a complete introduction to the general statistical use of sample size determination. Advanced topics including multivariate analysis, clinical trials, and quality improvement are addressed, and in addition, the book provides considerable guidance on available software for sample size determination. Written by a well-known author who has extensively class-tested the material, Sample Size Determination and Power: Highlights the applicability of sample size determination and provides extensive literature coverage Presents a modern, general approach to relevant software to guide sample size determination including CATD (computer-aided trial design) Addresses the use of sample size determination in grant proposals and provides up-to-date references for grant investigators An appealing reference book for scientific researchers in a variety of fields, such as statistics, biostatistics, the health sciences, mathematics, ecology, and geology, who use sampling and estimation methods in their work, Sample Size Determination and Power is also an ideal supplementary text for upper-level undergraduate and graduate-level courses in statistical sampling.

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