Sequential Medical Trials for Comparing an Experimental with a Standard Treatment

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Publisher :
ISBN 13 :
Total Pages : 256 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Sequential Medical Trials for Comparing an Experimental with a Standard Treatment by : A. John Petkau

Download or read book Sequential Medical Trials for Comparing an Experimental with a Standard Treatment written by A. John Petkau and published by . This book was released on 1975 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: The research is concerned with a cost function approach to the design of sequential medical trials for comparing an experimental with a standard treatment. It is assumed that all available patients must be treated with one of the two treatments. The standard and experimental treatments are characterized by known and unknown probabilities of success respectively. Two costs are considered; the cost incurred every time either of the treatments fails and a special cost per patient treated in the experimental portion of the plan.

Small Clinical Trials

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Publisher : National Academies Press
ISBN 13 : 9780309171144
Total Pages : 222 pages
Book Rating : 4.1/5 (711 download)

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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 and published by National Academies Press. This book was released on 2001-01-01 with total page 222 pages. 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.

The Prevention and Treatment of Missing Data in Clinical Trials

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Publisher : National Academies Press
ISBN 13 : 030918651X
Total Pages : 163 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council

Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Randomization in Clinical Trials

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Publisher : John Wiley & Sons
ISBN 13 : 1118742249
Total Pages : 284 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Randomization in Clinical Trials by : William F. Rosenberger

Download or read book Randomization in Clinical Trials written by William F. Rosenberger and published by John Wiley & Sons. This book was released on 2015-11-23 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition “All medical statisticians involved in clinical trials should read this book…” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics. William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley. John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley.

The Design and Analysis of Sequential Clinical Trials

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Publisher : Horwood Publishing Limited
ISBN 13 :
Total Pages : 280 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Design and Analysis of Sequential Clinical Trials by : John Whitehead

Download or read book The Design and Analysis of Sequential Clinical Trials written by John Whitehead and published by Horwood Publishing Limited. This book was released on 1983 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book details all aspects of sequential clinical trials from preliminary planning, through the monitoring of the trial, to the final analysis of the results.

Dynamic Programming and Its Applications

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Publisher : Academic Press
ISBN 13 : 1483258947
Total Pages : 426 pages
Book Rating : 4.4/5 (832 download)

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Book Synopsis Dynamic Programming and Its Applications by : Martin L. Puterman

Download or read book Dynamic Programming and Its Applications written by Martin L. Puterman and published by Academic Press. This book was released on 2014-05-10 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dynamic Programming and Its Applications provides information pertinent to the theory and application of dynamic programming. This book presents the development and future directions for dynamic programming. Organized into four parts encompassing 23 chapters, this book begins with an overview of recurrence conditions for countable state Markov decision problems, which ensure that the optimal average reward exists and satisfies the functional equation of dynamic programming. This text then provides an extensive analysis of the theory of successive approximation for Markov decision problems. Other chapters consider the computational methods for deterministic, finite horizon problems, and present a unified and insightful presentation of several foundational questions. This book discusses as well the relationship between policy iteration and Newton's method. The final chapter deals with the main factors severely limiting the application of dynamic programming in practice. This book is a valuable resource for growth theorists, economists, biologists, mathematicians, and applied management scientists.

Adaptive Statistical Procedures and Related Topics

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Publisher : IMS
ISBN 13 : 9780940600096
Total Pages : 496 pages
Book Rating : 4.6/5 ( download)

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Book Synopsis Adaptive Statistical Procedures and Related Topics by : John Van Ryzin

Download or read book Adaptive Statistical Procedures and Related Topics written by John Van Ryzin and published by IMS. This book was released on 1986 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Group Sequential Methods with Applications to Clinical Trials

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Publisher : CRC Press
ISBN 13 : 9781584888581
Total Pages : 416 pages
Book Rating : 4.8/5 (885 download)

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Book Synopsis Group Sequential Methods with Applications to Clinical Trials by : Christopher Jennison

Download or read book Group Sequential Methods with Applications to Clinical Trials written by Christopher Jennison and published by CRC Press. This book was released on 1999-09-15 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion. Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models. Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.

Annual Department of Defense Bibliography of Logistics Studies and Related Documents

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Publisher :
ISBN 13 :
Total Pages : 960 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Annual Department of Defense Bibliography of Logistics Studies and Related Documents by : United States. Defense Logistics Studies Information Exchange

Download or read book Annual Department of Defense Bibliography of Logistics Studies and Related Documents written by United States. Defense Logistics Studies Information Exchange and published by . This book was released on 1976 with total page 960 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Design of Studies for Medical Research

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Publisher : John Wiley & Sons
ISBN 13 : 0470012986
Total Pages : 286 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis The Design of Studies for Medical Research by : David Machin

Download or read book The Design of Studies for Medical Research written by David Machin and published by John Wiley & Sons. This book was released on 2005-05-13 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: The same careful rigour imposed on the design of phase III randomised controlled trials is not always applied to medical research in other areas such as trials conducted at earlier stages of drug development. With the emphasis that is now placed on evidence-based medicine, such care and rigour will inevitably impact on these areas with increasing attention turned to the quality of design. This title describes what principles can be used to structure research effectively allowing for the required degree of accuracy. Written by two best selling authors, this book includes many examples from medical literature and will be of great value to all groups conducting studies at the interface of clinical and laboratory research.

Finding What Works in Health Care

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Publisher : National Academies Press
ISBN 13 : 0309164257
Total Pages : 267 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Finding What Works in Health Care by : Institute of Medicine

Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.

Principles and Practice of Clinical Trials

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Publisher : Springer Nature
ISBN 13 : 3319526367
Total Pages : 2573 pages
Book Rating : 4.3/5 (195 download)

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Book Synopsis Principles and Practice of Clinical Trials by : Steven Piantadosi

Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Journal of the American Statistical Association

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Publisher :
ISBN 13 :
Total Pages : 780 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Journal of the American Statistical Association by : American Statistical Association

Download or read book Journal of the American Statistical Association written by American Statistical Association and published by . This book was released on 2000 with total page 780 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Sequential Medical Trials

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ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (729 download)

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Book Synopsis Sequential Medical Trials by : P. Armitage

Download or read book Sequential Medical Trials written by P. Armitage and published by . This book was released on 1980 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Design, Execution, and Management of Medical Device Clinical Trials

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Publisher : John Wiley & Sons
ISBN 13 : 0470474262
Total Pages : 294 pages
Book Rating : 4.4/5 (74 download)

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Book Synopsis Design, Execution, and Management of Medical Device Clinical Trials by : Salah M. Abdel-aleem

Download or read book Design, Execution, and Management of Medical Device Clinical Trials written by Salah M. Abdel-aleem and published by John Wiley & Sons. This book was released on 2009-09-08 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.

Modern Approaches to Clinical Trials Using SAS

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Publisher : SAS Institute
ISBN 13 : 1629600822
Total Pages : 482 pages
Book Rating : 4.6/5 (296 download)

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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 and published by SAS Institute. This book was released on 2015-12-09 with total page 482 pages. 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.

Quality Control and Applied Statistics

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Publisher :
ISBN 13 :
Total Pages : 618 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Quality Control and Applied Statistics by :

Download or read book Quality Control and Applied Statistics written by and published by . This book was released on 1979 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: