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Modern Clinical Trial Analysis

2012-09-05 Medical
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Release : 2012-09-05
Genre : Medical
Kind : eBook
Book Rating : 229/5 ( reviews)

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Book Synopsis Modern Clinical Trial Analysis by : Wan Tang

Download or read book Modern Clinical Trial Analysis written by Wan Tang. This book was released on 2012-09-05. Available in PDF, EPUB and Kindle. Book excerpt: This volume covers classic as well as cutting-edge topics on the analysis of clinical trial data in biomedical and psychosocial research and discusses each topic in an expository and user-friendly fashion. The intent of the book is to provide an overview of the primary statistical and data analytic issues associated with each of the selected topics, followed by a discussion of approaches for tackling such issues and available software packages for carrying out analyses. While classic topics such as survival data analysis, analysis of diagnostic test data and assessment of measurement reliability are well known and covered in depth by available topic-specific texts, this volume serves a different purpose: it provides a quick introduction to each topic for self-learning, particularly for those who have not done any formal coursework on a given topic but must learn it due to its relevance to their multidisciplinary research. In addition, the chapters on these classic topics will reflect issues particularly relevant to modern clinical trials such as longitudinal designs and new methods for analyzing data from such study designs. The coverage of these topics provides a quick introduction to these important statistical issues and methods for addressing them. As with the classic topics, this part of the volume on modern topics will enable researchers to grasp the statistical methods for addressing these emerging issues underlying modern clinical trials and to apply them to their research studies.

Small Clinical Trials

2001-01-01 Medical
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Release : 2001-01-01
Genre : Medical
Kind : eBook
Book Rating : 148/5 ( reviews)

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Book Synopsis Small Clinical Trials by : Institute of Medicine

Download or read book Small Clinical Trials written by Institute of Medicine. This book was released on 2001-01-01. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Modern Approaches to Clinical Trials Using SAS

2015-12-09 Computers
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Release : 2015-12-09
Genre : Computers
Kind : eBook
Book Rating : 822/5 ( reviews)

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Book Synopsis Modern Approaches to Clinical Trials Using SAS by : Sandeep Menon

Download or read book Modern Approaches to Clinical Trials Using SAS written by Sandeep Menon. This book was released on 2015-12-09. Available in PDF, EPUB and Kindle. Book excerpt: Get the tools you need to use SAS® in clinical trial design! Unique and multifaceted, Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods, edited by Sandeep M. Menon and Richard C. Zink, thoroughly covers several domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods that are applicable to and widely used in various phases of pharmaceutical development. Written for biostatisticians, pharmacometricians, clinical developers, and statistical programmers involved in the design, analysis, and interpretation of clinical trials, as well as students in graduate and postgraduate programs in statistics or biostatistics, the book touches on a wide variety of topics, including dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs that incorporate historical data; adaptive sample size re-estimation; adaptive randomization to allocate subjects to more effective treatments; and population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology, and rheumatology. Individual chapters are authored by renowned contributors, experts, and key opinion leaders from the pharmaceutical/medical device industry or academia. Numerous real-world examples and sample SAS code enable users to readily apply novel clinical trial design and analysis methodologies in practice.

Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials

2019-03-20 Mathematics
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Release : 2019-03-20
Genre : Mathematics
Kind : eBook
Book Rating : 535/5 ( reviews)

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Book Synopsis Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials by : Mark Chang

Download or read book Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials written by Mark Chang. This book was released on 2019-03-20. Available in PDF, EPUB and Kindle. Book excerpt: "This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.

Meta-Analysis of Controlled Clinical Trials

2003-01-17 Mathematics
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Release : 2003-01-17
Genre : Mathematics
Kind : eBook
Book Rating : 197/5 ( reviews)

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Book Synopsis Meta-Analysis of Controlled Clinical Trials by : Anne Whitehead

Download or read book Meta-Analysis of Controlled Clinical Trials written by Anne Whitehead. This book was released on 2003-01-17. Available in PDF, EPUB and Kindle. Book excerpt: Over the last twenty years there has been a dramatic upsurge in the application of meta-analysis to medical research. This has mainly been due to greater emphasis on evidence-based medicine and the need for reliable summaries of the vast and expanding volume of clinical research. At the same time there have been great strides in the development and refinement of the associated statistical methodology. This book describes the planning, conduct and reporting of a meta-analysis as applied to a series of randomized controlled clinical trials. * The various approaches are presented within a general unified framework. * Meta-analysis techniques are described in detail, from their theoretical development through to practical implementation. * Each topic discussed is supported by detailed worked examples. * A comparison of fixed and random effects approaches is included, as well as a discussion of Bayesian methods and cumulative meta-analysis. * Fully documented programs using standard statistical procedures in SAS are available on the Web. Ideally suited for practising statisticians and statistically-minded medical professionals, the book will also be of use to graduate students of medical statistics. The book is a self-contained and comprehensive account of the subject and an essential purchase for anyone involved in clinical trials.

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