Download or read book Interim analysis Second Edition written by Gerardus Blokdyk and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Interim analysis Second Edition.
Download or read book Interim Analysis Second Edition written by Gerardus Blokdyk and published by 5starcooks. This book was released on 2018-05-27 with total page 126 pages. Available in PDF, EPUB and Kindle. Book excerpt: Is a Interim analysis Team Work effort in place? in other words, can we track that any Interim analysis project is implemented as planned, and is it working? How do we maintain Interim analysis's Integrity? Why are Interim analysis skills important? What are the rough order estimates on cost savings/opportunities that Interim analysis brings? This breakthrough Interim analysis self-assessment will make you the credible Interim analysis domain leader by revealing just what you need to know to be fluent and ready for any Interim analysis challenge. How do I reduce the effort in the Interim analysis work to be done to get problems solved? How can I ensure that plans of action include every Interim analysis task and that every Interim analysis outcome is in place? How will I save time investigating strategic and tactical options and ensuring Interim analysis costs are low? How can I deliver tailored Interim analysis advice instantly with structured going-forward plans? There's no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all Interim analysis essentials are covered, from every angle: the Interim analysis self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that Interim analysis outcomes are achieved. Contains extensive criteria grounded in past and current successful projects and activities by experienced Interim analysis practitioners. Their mastery, combined with the easy elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in Interim analysis are maximized with professional results. Your purchase includes access details to the Interim analysis self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows you exactly what to do next. Your exclusive instant access details can be found in your book.
Download or read book Sample Size Calculations in Clinical Research Second Edition written by Shein-Chung Chow and published by CRC Press. This book was released on 2007-08-22 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Statistical Thinking for Non Statisticians in Drug Regulation written by Richard Kay and published by John Wiley & Sons. This book was released on 2014-10-23 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials. It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability to read, understand and critically appraise statistical methodology in papers and reports. As such, it is directly concerned with the day-to-day practice and the regulatory requirements of drug development and clinical trials. Fully conversant with current regulatory requirements, this second edition includes five new chapters covering Bayesian statistics, adaptive designs, observational studies, methods for safety analysis and monitoring and statistics for diagnosis. Authored by a respected lecturer and consultant to the pharmaceutical industry, Statistical Thinking for Non-Statisticians in Drug Regulation is an ideal guide for physicians, clinical research scientists, managers and associates, data managers, medical writers, regulatory personnel and for all non-statisticians working and learning within the pharmaceutical industry.
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.
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.
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.
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.
Download or read book Statistics in Medicine written by Robert H. Riffenburgh and published by Academic Press. This book was released on 2006 with total page 680 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medicine deals with treatments that work often but not always, so treatment success must be based on probability. Statistical methods lift medical research from the anecdotal to measured levels of probability. This book presents the common statistical methods used in 90% of medical research, along with the underlying basics, in two parts: a textbook section for use by students in health care training programs, e.g., medical schools or residency training, and a reference section for use by practicing clinicians in reading medical literature and performing their own research. The book does not require a significant level of mathematical knowledge and couches the methods in multiple examples drawn from clinical medicine, giving it applicable context. Easy-to-follow format incorporates medical examples, step-by-step methods, and check yourself exercises Two-part design features course material and a professional reference section Chapter summaries provide a review of formulas, method algorithms, and check lists Companion site links to statistical databases that can be downloaded and used to perform the exercises from the book and practice statistical methods New in this Edition: New chapters on: multifactor tests on means of continuous data, equivalence testing, and advanced methods New topics include: trial randomization, treatment ethics in medical research, imputation of missing data, and making evidence-based medical decisions Updated database coverage and additional exercises Expanded coverage of numbers needed to treat and to benefit, and regression analysis including stepwise regression and Cox regression Thorough discussion on required sample size
Download or read book Statistical Thinking in Clinical Trials written by Michael A. Proschan and published by CRC Press. This book was released on 2021-11-24 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Thinking in Clinical Trials combines a relatively small number of key statistical principles and several instructive clinical trials to gently guide the reader through the statistical thinking needed in clinical trials. Randomization is the cornerstone of clinical trials and randomization-based inference is the cornerstone of this book. Read this book to learn the elegance and simplicity of re-randomization tests as the basis for statistical inference (the analyze as you randomize principle) and see how re-randomization tests can save a trial that required an unplanned, mid-course design change. Other principles enable the reader to quickly and confidently check calculations without relying on computer programs. The `EZ’ principle says that a single sample size formula can be applied to a multitude of statistical tests. The `O minus E except after V’ principle provides a simple estimator of the log odds ratio that is ideally suited for stratified analysis with a binary outcome. The same principle can be used to estimate the log hazard ratio and facilitate stratified analysis in a survival setting. Learn these and other simple techniques that will make you an invaluable clinical trial statistician.
Download or read book Lifestyle Medicine Second Edition written by James M. Rippe and published by CRC Press. This book was released on 2013-03-15 with total page 1633 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is no doubt that daily habits and actions exert a profound health impact. The fact that nutritional practices, level of physical activity, weight management, and other behaviors play key roles both in the prevention and treatment of most metabolic diseases has been recognized by their incorporation into virtually every evidence-based medical guideline. Despite this widespread recognition, physicians and other healthcare workers often cannot find a definitive and comprehensive source of information on all of these areas. Designed for physicians and other health care workers, Lifestyle Medicine, Second Edition brings together evidence-based research in multiple health-related fields to assist practitioners both in treating disease and promoting good health. Sections cover nutrition and exercise, behavioral psychology, public policy, and management of a range of disorders, including cardiovascular disease, endocrine and metabolic dysfunction, obesity, cancer, immunology and infectious diseases, pulmonary disorders, and many more.
Download or read book Model Rules of Professional Conduct written by American Bar Association. House of Delegates and published by American Bar Association. This book was released on 2007 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
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.
Download or read book Adaptive Design Theory and Implementation Using SAS and R Second Edition written by Mark Chang and published by CRC Press. This book was released on 2014-12-01 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer Science & Business Media. This book was released on 1998 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.
Download or read book Multiple Comparisons and Multiple Tests Using SAS Second Edition written by Peter H. Westfall and published by SAS Institute. This book was released on 2011 with total page 645 pages. Available in PDF, EPUB and Kindle. Book excerpt: New and extensively updated for SAS 9 and later, this work provides cutting-edge methods, specialized macros, and proven best bet procedures. The book also discusses the pitfalls and advantages of various methods, thereby helping readers to decide which is the most appropriate for their purposes. 644 pp. Pub. 7/11.
Download or read book The Design and Analysis of Sequential Clinical Trials written by John Whitehead and published by John Wiley & Sons. This book was released on 1997-08-04 with total page 342 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. Emphasis is placed on the triangular test and other procedures based on straight line stopping boundaries. These methods allow for frequent or occasional interim analyses and permit the analysis of a wide variety of patient responses. Alternative procedures are also covered in detail, and these include -spending function methods, repeated confidence intervals and Bayesian approaches to sequential clinical trials.
