adaptive design theory and implementation using sas and r second edition chapman hall crc biostatistics series

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Adaptive Design Theory And Implementation Using Sas And R Second Edition

Author : Mark Chang
ISBN : 9781482256598
Genre : Mathematics
File Size : 44. 22 MB
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Get Up to Speed on Many Types of Adaptive Designs Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials. New to the Second Edition Twelve new chapters covering blinded and semi-blinded sample size reestimation design, pick-the-winners design, biomarker-informed adaptive design, Bayesian designs, adaptive multiregional trial design, SAS and R for group sequential design, and much more More analytical methods for K-stage adaptive designs, multiple-endpoint adaptive design, survival modeling, and adaptive treatment switching New material on sequential parallel designs with rerandomization and the skeleton approach in adaptive dose-escalation trials Twenty new SAS macros and R functions Enhanced end-of-chapter problems that give readers hands-on practice addressing issues encountered in designing real-life adaptive trials Covering even more adaptive designs, this book provides biostatisticians, clinical scientists, and regulatory reviewers with up-to-date details on this innovative area in pharmaceutical research and development. Practitioners will be able to improve the efficiency of their trial design, thereby reducing the time and cost of drug development.

Introductory Adaptive Trial Designs

Author : Mark Chang
ISBN : 9781498717472
Genre : Mathematics
File Size : 63. 42 MB
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All the Essentials to Start Using Adaptive Designs in No Time Compared to traditional clinical trial designs, adaptive designs often lead to increased success rates in drug development at reduced costs and time. Introductory Adaptive Trial Designs: A Practical Guide with R motivates newcomers to quickly and easily grasp the essence of adaptive designs as well as the foundations of adaptive design methods. The book reduces the mathematics to a minimum and makes the material as practical as possible. Instead of providing general, black-box commercial software packages, the author includes open-source R functions that enable readers to better understand the algorithms and customize the designs to meet their needs. Readers can run the simulations for all the examples and change the input parameters to see how each input parameter affects the simulation outcomes or design operating characteristics. Taking a learning-by-doing approach, this tutorial-style book guides readers on planning and executing various types of adaptive designs. It helps them develop the skills to begin using the designs immediately.

Data And Safety Monitoring Committees In Clinical Trials Second Edition

Author : Jay Herson
ISBN : 9781351722377
Genre : Mathematics
File Size : 42. 97 MB
Format : PDF
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Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician ? In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. ? New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members ? Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry. ? ? ? ? ? ? ? ? ? ? ? ? ?

Applied Surrogate Endpoint Evaluation Methods With Sas And R

Author : Ariel Alonso
ISBN : 9781315355368
Genre : Mathematics
File Size : 35. 39 MB
Format : PDF, Kindle
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An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment’s efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate endpoint that can be measured in a more convenient or cost-effective way. This book focuses on the use of surrogate endpoint evaluation methods in practice, using SAS and R.

Medical Biostatistics Second Edition

Author : Abhaya Indrayan
ISBN : 9781584888888
Genre : Mathematics
File Size : 37. 96 MB
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Emphasizing statistical concepts used in medicine, the interpretation of methods, and applications, Medical Biostatistics, Second Edition shows how biostatistical methods are important tools in managing uncertainties in medicine and the health sciences. With coverage ranging from elementary topics, such as mean and standard deviation, to advanced approaches, such as logistic regression and multivariate methods, this edition is even more far-reaching in scope than its predecessor. New to the Second Edition Full chapters on clinical trials, observational studies, laboratory experiments, survival analysis, and logistic regression A new chapter on clinimetrics and evidence-based medicine Expanded discussions on epistemic uncertainties, crossover designs, equivalence trials and studies, hazard functions, and the log-rank test The introduction of research evidence, multilevel regression, classification, and regression trees at an elementary level Sample size formulas for relative risk, odds ratio, and survival studies Numerous additional examples from contemporary medical literature Numbered steps for the many procedures and remarks Requiring only high school algebra, this text enables a solid understanding of the statistical concepts required to critically examine medical literature, scientifically plan and carry out medical investigations, and meaningfully analyze data.

Adaptive Design Methods In Clinical Trials Second Edition

Author : Shein-Chung Chow
ISBN : 9781439839881
Genre : Mathematics
File Size : 44. 25 MB
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With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA’s recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology. New to the Second Edition Along with revisions throughout the text, this edition significantly updates the chapters on protocol amendment and clinical trial simulation to incorporate the latest changes. It also includes five entirely new chapters on two-stage adaptive design, biomarker adaptive trials, target clinical trials, sample size and power estimation, and regulatory perspectives. Following in the tradition of its acclaimed predecessor, this second edition continues to offer an up-to-date resource for clinical scientists and researchers in academia, regulatory agencies, and the pharmaceutical industry. Written in an intuitive style at a basic mathematical and statistical level, the book maintains its practical approach with an emphasis on concepts via numerous examples and illustrations.

Sample Size Calculations In Clinical Research Second Edition

Author : Shein-Chung Chow
ISBN : 9781439870938
Genre : Mathematics
File Size : 61. 15 MB
Format : PDF, Kindle
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Focusing on an integral part of pharmaceutical development, Sample Size Calculations in Clinical Research, Second Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. It provides sample size formulas and procedures for testing equality, noninferiority/superiority, and equivalence. A comprehensive and unified presentation of statistical concepts and practical applications, this book highlights the interactions between clinicians and biostatisticians, includes a well-balanced summary of current and emerging clinical issues, and explores recently developed statistical methodologies for sample size calculation. Whenever possible, each chapter provides a brief history or background, regulatory requirements, statistical designs and methods for data analysis, real-world examples, future research developments, and related references. One of the few books to systematically summarize clinical research procedures, this edition contains new chapters that focus on three key areas of this field. Incorporating the material of this book in your work will help ensure the validity and, ultimately, the success of your clinical studies.

Sample Size Calculations In Clinical Research

Author : Shein-Chung Chow
ISBN : 0203911342
Genre : Mathematics
File Size : 75. 47 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.

R In A Nutshell

Author : Joseph Adler
ISBN : 9783897216501
Genre : Computers
File Size : 27. 68 MB
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Wozu sollte man R lernen? Da gibt es viele Gründe: Weil man damit natürlich ganz andere Möglichkeiten hat als mit einer Tabellenkalkulation wie Excel, aber auch mehr Spielraum als mit gängiger Statistiksoftware wie SPSS und SAS. Anders als bei diesen Programmen hat man nämlich direkten Zugriff auf dieselbe, vollwertige Programmiersprache, mit der die fertigen Analyse- und Visualisierungsmethoden realisiert sind – so lassen sich nahtlos eigene Algorithmen integrieren und komplexe Arbeitsabläufe realisieren. Und nicht zuletzt, weil R offen gegenüber beliebigen Datenquellen ist, von der einfachen Textdatei über binäre Fremdformate bis hin zu den ganz großen relationalen Datenbanken. Zudem ist R Open Source und erobert momentan von der universitären Welt aus die professionelle Statistik. R kann viel. Und Sie können viel mit R machen – wenn Sie wissen, wie es geht. Willkommen in der R-Welt: Installieren Sie R und stöbern Sie in Ihrem gut bestückten Werkzeugkasten: Sie haben eine Konsole und eine grafische Benutzeroberfläche, unzählige vordefinierte Analyse- und Visualisierungsoperationen – und Pakete, Pakete, Pakete. Für quasi jeden statistischen Anwendungsbereich können Sie sich aus dem reichen Schatz der R-Community bedienen. Sprechen Sie R! Sie müssen Syntax und Grammatik von R nicht lernen – wie im Auslandsurlaub kommen Sie auch hier gut mit ein paar aufgeschnappten Brocken aus. Aber es lohnt sich: Wenn Sie wissen, was es mit R-Objekten auf sich hat, wie Sie eigene Funktionen schreiben und Ihre eigenen Pakete schnüren, sind Sie bei der Analyse Ihrer Daten noch flexibler und effektiver. Datenanalyse und Statistik in der Praxis: Anhand unzähliger Beispiele aus Medizin, Wirtschaft, Sport und Bioinformatik lernen Sie, wie Sie Daten aufbereiten, mithilfe der Grafikfunktionen des lattice-Pakets darstellen, statistische Tests durchführen und Modelle anpassen. Danach werden Ihnen Ihre Daten nichts mehr verheimlichen.

Programmieren Mit R

Author : Uwe Ligges
ISBN : 9783540799986
Genre : Computers
File Size : 45. 76 MB
Format : PDF, ePub
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R ist eine objektorientierte und interpretierte Sprache und Programmierumgebung für Datenanalyse und Grafik. Ausführlich führt der Autor in die Grundlagen ein und vermittelt eingängig die Struktur der Sprache. So ermöglicht er Lesern den leichten Einstieg: eigene Methoden umsetzen, Objektklassen definieren und Pakete aus Funktionen und zugehöriger Dokumentation zusammenstellen. Detailliert beschreibt er die enormen Grafikfähigkeiten von R. Für alle, die R als flexibles Werkzeug zur Datenanalyse und -visualisierung einsetzen. In 2. Auflage mit vielen Verbesserungen und Neuerungen von R-2.3.x und weiteren von Lesern gewünschten Ergänzungen.

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