The Power Trial Method, Second Edition, a unique, easy-to-read trial skills primer, begins with a simple question about jury trials: Who has the power in the courtroom to decide whether you win or lose? David J.F. Gross and Charles F. Webber, two of the nation's most highly regarded trial lawyers, developed this material to introduce new litigators to the trial process and to reduce the anxiety associated with jury trials by emphasizing key methods of persuasion and presentation.
Although adaptive design methods are flexible and useful in clinical research, little or no regulatory guidelines are available. One of the first books on the topic, Adaptive Design Methods in Clinical Trials presents the principles and methodologies in adaptive design and analysis that pertain to adaptations made to trial or statistical procedures
Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods includes updates of established literature from the Wiley Encyclopedia of Clinical Trials as well as original material based on the latest developments in clinical trials. Prepared by a leading expert, the second volume includes numerous contributions from current prominent experts in the field of medical research. In addition, the volume features: • Multiple new articles exploring emerging topics, such as evaluation methods with threshold, empirical likelihood methods, nonparametric ROC analysis, over- and under-dispersed models, and multi-armed bandit problems • Up-to-date research on the Cox proportional hazard model, frailty models, trial reports, intrarater reliability, conditional power, and the kappa index • Key qualitative issues including cost-effectiveness analysis, publication bias, and regulatory issues, which are crucial to the planning and data management of clinical trials
The Power Trial Method, Second Edition, a unique, easy-to-read trial skills primer, begins with a simple question about jury trials: Who has the power in the courtroom to decide whether you win or lose? David J.F. Gross and Charles F. Webber, two of the nation's most highly regarded trial lawyers, developed this material to introduce new litigators to the trial process and to reduce the anxiety associated with jury trials by emphasizing key methods of persuasion and presentation.
Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors' courses on the subject as well as the first author's more than 30 years wor
This book covers domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods applicable to and 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, it covers topics including: dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs incorporating historical data; adaptive sample size re-estimation and randomization to allocate subjects to effective treatments; population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology and rheumatology. --
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.
Although the propeller lies submerged out of sight, it is a complex component in both the hydrodynamic and structural sense. This book fulfils the need for a comprehensive and cutting edge volume that brings together a great range of knowledge on propulsion technology, a multi-disciplinary and international subject. The book comprises three main sections covering hydrodynamics; materials and mechanical considerations; and design, operation and performance. The discussion relates theory to practical problems of design, analysis and operational economy, and is supported by extensive design information, operational detail and tabulated data. Fully updated and revised to cover the latest advances in the field, the new edition now also includes four new chapters on azimuthing and podded propulsors, propeller-rudder interaction, high-speed propellers, and propeller-ice interaction.·The most complete book available on marine propellers, fully updated and revised, with four new chapters on azimuthing and podded propulsors, propeller-rudder interaction, high-speed propellers, and propeller-ice interaction·A valuable reference for marine engineers and naval architects gathering together the subject of propulsion technology, in both theory and practice, over the last forty years ·Written by a leading expert on propeller technology, essential for students of propulsion and hydrodynamics, complete with online worked examples
The authoritative guide for Data Monitoring Committees—fully revised and updated The number of clinical trials sponsored by government agencies and pharmaceutical companies has grown in recent years, prompting an increased need for interim monitoring of data on safety and efficacy. Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and protecting the credibility and validity of the study. Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition offers practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees, providing a practical overview of the establishment, purpose, and responsibilities of these committees. Examination of topics such as the composition and independence of DMCs, statistical, philosophical and ethical considerations, and determining when a DMC is needed, presents readers with a comprehensive foundational knowledge of clinical trial oversight. Providing recent examples to illustrate DMC principles, this fully-updated guide reflects current developments and practices in clinical trial oversight and offers expanded coverage of emerging issues and challenges in the field. This new second edition covers the most current information on DMC policies, issues in monitoring trials using new designs, and recent trial publications relevant to DMC decision-making. • Presents practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees • Illustrates the types of challenging issues Data Monitoring Committees face in practical situations • Provides updated and expanded coverage of topics including regulatory and funding agency guidelines and trial designs and their associated demands and limitations • Includes a new chapter addressing legal issues that affect DMC members and discusses general litigation concerns relevant to clinical research • Expands treatment of current journal publications addressing DMC issues Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition is a must-have text for anyone engaged in DMC activities as well as trial sponsors, clinical trial researchers, regulatory and bioethics professionals, and those associated with clinical trials in academic, government and industry settings.
