Advances In Clinical Trial Biostatistics

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Recent Advances in Clinical Trial Design and Analysis

Author : Peter F. Thall
Publisher : Springer Science & Business Media
Page : 263 pages
File Size : 45,9 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9781461520092

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Recent Advances in Clinical Trial Design and Analysis by Peter F. Thall Pdf

Clinical trials have two purposes -- to treat the patients in the trial, and to obtain information which increases our understanding of the disease and especially how patients respond to treatment. Statistical design provides a means to achieve both these aims, while statistical data analysis provides methods for extracting useful information from the trial data. Recent advances in statistical computing have enabled statisticians to implement very rapidly a broad array of methods which previously were either impractical or impossible. Biostatisticians are now able to provide much greater support to medical researchers working in both clinical and laboratory settings. As our collective toolkit of techniques for analyzing data has grown, it has become increasingly difficult for biostatisticians to keep up with all the developments in our own field. Recent Advances in Clinical Trial Design and Analysis brings together biostatisticians doing cutting-edge research and explains some of the more recent developments in biostatistics to clinicians and scientists who work in clinical trials.

Advances in Clinical Trial Biostatistics

Author : Nancy L. Geller
Publisher : CRC Press
Page : 308 pages
File Size : 47,8 Mb
Release : 2003-10-21
Category : Mathematics
ISBN : 0203912888

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Advances in Clinical Trial Biostatistics by Nancy L. Geller Pdf

From aspects of early trials to complex modeling problems, Advances in Clinical Trial Biostatistics summarizes current methodologies used in the design and analysis of clinical trials. Its chapters, contributed by internationally renowned methodologists experienced in clinical trials, address topics that include Bayesian methods for phase I clinical trials, adaptive two-stage clinical trials, and the design and analysis of cluster randomization trials, trials with multiple endpoints, and therapeutic equivalence trials. Other discussions explore Bayesian reporting, methods incorporating compliance in treatment evaluation, and statistical issues emerging from clinical trials in HIV infection.

Statistics in Medical Research

Author : E.A. Gehan,N.A. Lemak
Publisher : Springer Science & Business Media
Page : 214 pages
File Size : 46,5 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9781461525189

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Statistics in Medical Research by E.A. Gehan,N.A. Lemak Pdf

In 1890, General Francis A. Walker, president of both the Massachusetts Institute of Technology and the American Statistical Association, wrote There is reason to wish that all citizens, from the highest to the lowest, might undergo so much of training in statistics as should enable them to detect the errors lurking in quantitative statements regarding social and economic matters which may ... be ad dressed to them as voters or as critics of public policies. [E A. Walker, 1890; reprinted in Noether, 1989] It has been more than a century since Walker stated his wish, but progress has been slow, just as advancement in the establishment of statistical principles and methodology has been laborious and difficult over the centuries. We have tried to describe the milestones in this development and how each generation of scientists built on the heritage and foundations laid by their predecessors. Many historians dismiss the "great man theory," which alleges that giant "leaps of human knowledge are made by great thinkers who transcend the boundaries of their times; great scientists don't leap outside their time, but somewhere else in their own time" (Hevly, 1990). We found this to be the case in the history of statistics. Even the innovative writings of Karl Pearson and Sir Ronald Fisher that became the foundation of modern mathematical statistics were the outcome of two centuries of antecedent ideas and information.

Developments in Statistical Evaluation of Clinical Trials

Author : Kees van Montfort,Johan Oud,Wendimagegn Ghidey
Publisher : Springer
Page : 361 pages
File Size : 52,9 Mb
Release : 2014-10-07
Category : Mathematics
ISBN : 9783642553455

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Developments in Statistical Evaluation of Clinical Trials by Kees van Montfort,Johan Oud,Wendimagegn Ghidey Pdf

This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

Advanced Medical Statistics (2nd Edition)

Author : Lu Ying,Fang Ji-qian,Tian Lu
Publisher : World Scientific
Page : 1472 pages
File Size : 46,5 Mb
Release : 2015-06-29
Category : Medical
ISBN : 9789814583329

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Advanced Medical Statistics (2nd Edition) by Lu Ying,Fang Ji-qian,Tian Lu Pdf

The book aims to provide both comprehensive reviews of the classical methods and an introduction to new developments in medical statistics. The topics range from meta analysis, clinical trial design, causal inference, personalized medicine to machine learning and next generation sequence analysis. Since the publication of the first edition, there have been tremendous advances in biostatistics and bioinformatics. The new edition tries to cover as many important emerging areas and reflect as much progress as possible. Many distinguished scholars, who greatly advanced their research areas in statistical methodology as well as practical applications, also have revised several chapters with relevant updates and written new ones from scratch.The new edition has been divided into four sections, including, Statistical Methods in Medicine and Epidemiology, Statistical Methods in Clinical Trials, Statistical Genetics, and General Methods. To reflect the rise of modern statistical genetics as one of the most fertile research areas since the publication of the first edition, the brand new section on Statistical Genetics includes entirely new chapters reflecting the state of the art in the field.Although tightly related, all the book chapters are self-contained and can be read independently. The book chapters intend to provide a convenient launch pad for readers interested in learning a specific topic, applying the related statistical methods in their scientific research and seeking the newest references for in-depth research.

Biostatistics in Clinical Trials

Author : Carol K. Redmond,Theodore Colton
Publisher : John Wiley & Sons
Page : 530 pages
File Size : 47,5 Mb
Release : 2001-04-25
Category : Medical
ISBN : 9780471822110

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Biostatistics in Clinical Trials by Carol K. Redmond,Theodore Colton Pdf

"Biostatistics in Clinical Trials" gehört zur Reihe 'Wiley Reference Series in Biostatistics' und basiert auf der renommierten 'Encyclopedia of Biostatistics'. Dieser Band enthält 25% neues Material, umfassend aktualisierte Artikel und Verweise aus der Enzyklopädie sowie prägnante Definitionen und Einführungen in zahlreiche Grundlagen aus der aktuellen Literatur. Darüber hinaus wird eine Reihe neuer Themen behandelt, wie z.B. Bayesche Methoden, ethische Fragen und die Nutzen-Risiko-Bewertung. Durch umfangreiche Querverweise findet der Leser rasch Definitionen und verwandte Konzepte .

Advanced Statistics in Regulatory Critical Clinical Initiatives

Author : Wei Zhang,Fangrong Yan,Feng Chen,Shein-Chung Chow
Publisher : CRC Press
Page : 501 pages
File Size : 54,8 Mb
Release : 2022-05-25
Category : Mathematics
ISBN : 9781000568028

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Advanced Statistics in Regulatory Critical Clinical Initiatives by Wei Zhang,Fangrong Yan,Feng Chen,Shein-Chung Chow Pdf

Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields. Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.

Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials

Author : Thomas R. Fleming,Bruce S. Weir
Publisher : Springer Science & Business Media
Page : 245 pages
File Size : 51,6 Mb
Release : 2012-12-12
Category : Mathematics
ISBN : 9781461452454

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Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials by Thomas R. Fleming,Bruce S. Weir Pdf

This volume contains a selection of chapters base on papers presented at the Fourth Seattle Symposium in Biostatistics: Clinical Trials. The symposium was held in 2010 to celebrate the 40th anniversary of the University of Washington School of Public Health and Community Medicine. It featured keynote lectures by David DeMets and Susan Ellenberg and 16 invited presentations by other prominent researchers. The papers contained in this volume encompass recent methodological advances in several important clinical trials research, such as biomarkers, meta-analyses, sequential and adaptive clinical trials, and various genetic bioinformatic techniques. This volume will be a valuable reference for researchers and practitioners in the field of clinical trials.

Design of Experiments and Advanced Statistical Techniques in Clinical Research

Author : Basavarajaiah D. M.,Bhamidipati Narasimha Murthy
Publisher : Springer Nature
Page : 380 pages
File Size : 48,8 Mb
Release : 2020-11-05
Category : Medical
ISBN : 9789811582103

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Design of Experiments and Advanced Statistical Techniques in Clinical Research by Basavarajaiah D. M.,Bhamidipati Narasimha Murthy Pdf

Recent Statistical techniques are one of the basal evidence for clinical research, a pivotal in handling new clinical research and in evaluating and applying prior research. This book explores various choices of statistical tools and mechanisms, analyses of the associations among different clinical attributes. It uses advanced statistical methods to describe real clinical data sets, when the clinical processes being examined are still in the process. This book also discusses distinct methods for building predictive and probability distribution models in clinical situations and ways to assess the stability of these models and other quantitative conclusions drawn by realistic experimental data sets. Design of experiments and recent posthoc tests have been used in comparing treatment effects and precision of the experimentation. This book also facilitates clinicians towards understanding statistics and enabling them to follow and evaluate the real empirical studies (formulation of randomized control trial) that pledge insight evidence base for clinical practices. This book will be a useful resource for clinicians, postgraduates scholars in medicines, clinical research beginners and academicians to nurture high-level statistical tools with extensive scope.

Advances in Statistical Methods for the Health Sciences

Author : Jean-Louis Auget,N. Balakrishnan,Mounir Mesbah,Geert Molenberghs
Publisher : Springer Science & Business Media
Page : 540 pages
File Size : 40,5 Mb
Release : 2007-08-08
Category : Mathematics
ISBN : 9780817645427

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Advances in Statistical Methods for the Health Sciences by Jean-Louis Auget,N. Balakrishnan,Mounir Mesbah,Geert Molenberghs Pdf

Statistical methods have become an increasingly important and integral part of research in the health sciences. Many sophisticated methodologies have been developed for specific applications and problems. This self-contained comprehensive volume covers a wide range of topics pertaining to new statistical methods in the health sciences, including epidemiology, pharmacovigilance, quality of life, survival analysis, and genomics. The book will serve the health science community as well as practitioners, researchers, and graduate students in applied probability, statistics, and biostatistics.

Recent Advances in Biostatistics

Author : Manish Bhattacharjee,Sunil K. Dhar,Sundarraman Subramanian
Publisher : World Scientific
Page : 311 pages
File Size : 52,8 Mb
Release : 2011
Category : Science
ISBN : 9789814329804

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Recent Advances in Biostatistics by Manish Bhattacharjee,Sunil K. Dhar,Sundarraman Subramanian Pdf

This unique volume provides self-contained accounts of some recent trends in Biostatistics methodology and their applications. It includes state-of-the-art reviews and original contributions. The articles included in this volume are based on a careful sel

Advanced Medical Statistics

Author : Anonim
Publisher : Unknown
Page : 128 pages
File Size : 46,6 Mb
Release : 2024-06-02
Category : Electronic
ISBN : 9789814489676

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Advanced Medical Statistics by Anonim Pdf

Clinical Trials

Author : Steven Piantadosi
Publisher : Wiley-Interscience
Page : 632 pages
File Size : 54,9 Mb
Release : 1997
Category : Mathematics
ISBN : UOM:39015048589108

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Clinical Trials by Steven Piantadosi Pdf

This book gives the reader important accounts of basic statistical procedures used in clinical trials. It covers several areas of study, including biostatics, biomathematics, biometry and epidemiology. There is emphasis for trialists to learn good methodology while giving quality clinical treatment. Discusses and explores controversial issues such as ethics and offers pragmatic information regarding allegations of fraud or misconduct.

Case Studies in Innovative Clinical Trials

Author : Kristine Broglio,Binbing Yu
Publisher : CRC Press
Page : 303 pages
File Size : 51,5 Mb
Release : 2023-11-27
Category : Mathematics
ISBN : 9781000987218

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Case Studies in Innovative Clinical Trials by Kristine Broglio,Binbing Yu Pdf

Drug development is a strictly regulated area. As such, marketing approval of a new drug depends heavily, if not exclusively, on evidence generated from clinical trials. Drug development has seen tremendous innovation in science and technology that has revolutionized the treatment of some diseases. And yet, the statistical design and practical conduct of the clinical trials used to test new therapeutics for safety and efficacy have changed very little over the decades. Our approach to clinical trials is steeped in convention and tradition. The large, fixed, randomized controlled trial methods that have been the gold standard are well understood and expected by many trial stakeholders. However, this approach is not well suited to all aspects of modern drug development and the current competitive landscape. We now see new therapies that target a small fraction of the patient population, rare diseases with high unmet medical needs, and pediatric populations that must wait for years for new drug approvals from the time that therapies are approved in adults. Large randomized clinical trials are at best inefficient and at worst completely infeasible in many modern clinical settings. Advances in technology and data infrastructure call for innovations in clinical trial design. Despite advances in statistical methods, the availability of information, and computing power, the actual experience with innovative design in clinical trials across industry and academia is limited. This book will be an important showcase of the potential for these innovative designs in modern drug development and will be an important resource to guide those who wish to undertake them for themselves. This book is ideal for professionals in the pharmaceutical industry and regulatory agencies, but it will also be useful to academic researchers, faculty members, and graduate students in statistics, biostatistics, public health, and epidemiology due to its focus on innovation. Key Features: Is written by pharmaceutical industry experts, academic researchers, and regulatory reviewers; this is the first book providing a comprehensive set of case studies related to statistical methodology, implementation, regulatory considerations, and communication of complex innovative trial design Has a broad appeal to a multitude of readers across academia, industry, and regulatory agencies Each contribution is a practical case study that can speak to the benefits of an innovative approach but also balance that with the real-life challenges encountered A complete understanding of what is actually being done in modern clinical trials will broaden the reader’s capabilities and provide examples to first mimic and then customize and expand upon when exploring these ideas on their own

Statistical Advances in the Biomedical Sciences

Author : Atanu Biswas,Sujay Datta,Jason P. Fine,Mark R. Segal
Publisher : John Wiley & Sons
Page : 623 pages
File Size : 46,7 Mb
Release : 2007-12-14
Category : Mathematics
ISBN : 9780470181195

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Statistical Advances in the Biomedical Sciences by Atanu Biswas,Sujay Datta,Jason P. Fine,Mark R. Segal Pdf

The Most Comprehensive and Cutting-Edge Guide to Statistical Applications in Biomedical Research With the increasing use of biotechnology in medical research and the sophisticated advances in computing, it has become essential for practitioners in the biomedical sciences to be fully educated on the role statistics plays in ensuring the accurate analysis of research findings. Statistical Advances in the Biomedical Sciences explores the growing value of statistical knowledge in the management and comprehension of medical research and, more specifically, provides an accessible introduction to the contemporary methodologies used to understand complex problems in the four major areas of modern-day biomedical science: clinical trials, epidemiology, survival analysis, and bioinformatics. Composed of contributions from eminent researchers in the field, this volume discusses the application of statistical techniques to various aspects of modern medical research and illustrates how these methods ultimately prove to be an indispensable part of proper data collection and analysis. A structural uniformity is maintained across all chapters, each beginning with an introduction that discusses general concepts and the biomedical problem under focus and is followed by specific details on the associated methods, algorithms, and applications. In addition, each chapter provides a summary of the main ideas and offers a concluding remarks section that presents novel ideas, approaches, and challenges for future research. Complete with detailed references and insight on the future directions of biomedical research, Statistical Advances in the Biomedical Sciences provides vital statistical guidance to practitioners in the biomedical sciences while also introducing statisticians to new, multidisciplinary frontiers of application. This text is an excellent reference for graduate- and PhD-level courses in various areas of biostatistics and the medical sciences and also serves as a valuable tool for medical researchers, statisticians, public health professionals, and biostatisticians.