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Author : United States. Office of Civil and Defense Mobilization
Publisher :
ISBN 13 :
Total Pages : 736 pages
Book Rating : 4.:/5 (31 download)
Download or read book Interim Statistical Report written by United States. Office of Civil and Defense Mobilization and published by . This book was released on 1956 with total page 736 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Susan S. Ellenberg
Publisher : John Wiley & Sons
ISBN 13 : 0470854154
Total Pages : 208 pages
Book Rating : 4.4/5 (78 download)
Download or read book Data Monitoring Committees in Clinical Trials written by Susan S. Ellenberg and published by John Wiley & Sons. This book was released on 2003-01-17 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities. * Provides a practical overview of data monitoring in clinical trials. * Describes the purpose, responsibilities and operation of data monitoring committees. * Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees. * Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees. * Discusses issues pertinent to those working in clinical trials in both the US and Europe. The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.
Author : Peter F. Thall
Publisher : Springer Science & Business Media
ISBN 13 : 1461520096
Total Pages : 263 pages
Book Rating : 4.4/5 (615 download)
Download or read book Recent Advances in Clinical Trial Design and Analysis written by Peter F. Thall and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 263 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Steven Piantadosi
Publisher : Springer Nature
ISBN 13 : 3319526367
Total Pages : 2573 pages
Book Rating : 4.3/5 (195 download)
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.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author : Richard Chin
Publisher : Elsevier
ISBN 13 : 0080557937
Total Pages : 560 pages
Book Rating : 4.0/5 (85 download)
Download or read book Principles and Practice of Clinical Trial Medicine written by Richard Chin and published by Elsevier. This book was released on 2008-07-25 with total page 560 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. - Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data - Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine - Expert authorship whose experience includes running clinical trials in an academic as well as industry settings - Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy
Author : United States. Office of Civil and Defense Mobilization
Publisher :
ISBN 13 :
Total Pages : 240 pages
Book Rating : 4.3/5 (91 download)
Download or read book Annual Statistical Report written by United States. Office of Civil and Defense Mobilization and published by . This book was released on 1958 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Joseph Tal
Publisher : Academic Press
ISBN 13 : 0123869099
Total Pages : 279 pages
Book Rating : 4.1/5 (238 download)
Download or read book Strategy and Statistics in Clinical Trials written by Joseph Tal and published by Academic Press. This book was released on 2011-07-14 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: Delineates the statistical building blocks and concepts of clinical trials.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309171148
Total Pages : 221 pages
Book Rating : 4.3/5 (91 download)
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 221 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.
Author : David L. DeMets
Publisher : Springer Science & Business Media
ISBN 13 : 0387301070
Total Pages : 389 pages
Book Rating : 4.3/5 (873 download)
Download or read book Data Monitoring in Clinical Trials written by David L. DeMets and published by Springer Science & Business Media. This book was released on 2006-06-22 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: From the authors of "Fundamentals of Clinical Trials" which has sold over 15,000 copies world wide since its publication in 1998. No competition yet as the text does not focus on how to do clinical trials but on very specific situations that can be encountered during the process.
Author : Thomas D. Cook
Publisher : CRC Press
ISBN 13 : 1584880279
Total Pages : 465 pages
Book Rating : 4.5/5 (848 download)
Download or read book Introduction to Statistical Methods for Clinical Trials written by Thomas D. Cook and published by CRC Press. This book was released on 2007-11-19 with total page 465 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Stuart J. Pocock
Publisher : John Wiley & Sons
ISBN 13 : 1118794109
Total Pages : 228 pages
Book Rating : 4.1/5 (187 download)
Download or read book Clinical Trials written by Stuart J. Pocock and published by John Wiley & Sons. This book was released on 2013-07-17 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience.
Author : United States. Federal Civil Defense Administration
Publisher :
ISBN 13 :
Total Pages : 496 pages
Book Rating : 4.F/5 ( download)
Download or read book Annual Statistical Report written by United States. Federal Civil Defense Administration and published by . This book was released on 1955 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : OECD
Publisher : OECD Publishing
ISBN 13 : 9264250085
Total Pages : 152 pages
Book Rating : 4.2/5 (642 download)
Download or read book Economic Policy Reforms 2016 Going for Growth Interim Report written by OECD and published by OECD Publishing. This book was released on 2016-02-26 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: Going for Growth is the OECD’s regular report on structural reforms in policy areas that have been identified as priorities to boost incomes in OECD and selected non-OECD countries (Brazil, China, Colombia, India, Indonesia, Latvia, Russian Federation and South Africa).
Author : Weichung Joe Shih
Publisher : CRC Press
ISBN 13 : 1000462757
Total Pages : 405 pages
Book Rating : 4.0/5 (4 download)
Download or read book Statistical Design, Monitoring, and Analysis of Clinical Trials written by Weichung Joe Shih and published by CRC Press. This book was released on 2021-10-25 with total page 405 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. 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, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.
Author : Christopher Jennison
Publisher : CRC Press
ISBN 13 : 9781584888581
Total Pages : 416 pages
Book Rating : 4.8/5 (885 download)
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.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309465052
Total Pages : 69 pages
Book Rating : 4.3/5 (94 download)
Download or read book Envisioning the Data Science Discipline written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-05 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: The need to manage, analyze, and extract knowledge from data is pervasive across industry, government, and academia. Scientists, engineers, and executives routinely encounter enormous volumes of data, and new techniques and tools are emerging to create knowledge out of these data, some of them capable of working with real-time streams of data. The nation's ability to make use of these data depends on the availability of an educated workforce with necessary expertise. With these new capabilities have come novel ethical challenges regarding the effectiveness and appropriateness of broad applications of data analyses. The field of data science has emerged to address the proliferation of data and the need to manage and understand it. Data science is a hybrid of multiple disciplines and skill sets, draws on diverse fields (including computer science, statistics, and mathematics), encompasses topics in ethics and privacy, and depends on specifics of the domains to which it is applied. Fueled by the explosion of data, jobs that involve data science have proliferated and an array of data science programs at the undergraduate and graduate levels have been established. Nevertheless, data science is still in its infancy, which suggests the importance of envisioning what the field might look like in the future and what key steps can be taken now to move data science education in that direction. This study will set forth a vision for the emerging discipline of data science at the undergraduate level. This interim report lays out some of the information and comments that the committee has gathered and heard during the first half of its study, offers perspectives on the current state of data science education, and poses some questions that may shape the way data science education evolves in the future. The study will conclude in early 2018 with a final report that lays out a vision for future data science education.
