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Designs for Clinical Trials
This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials.
Building Your Career as a Statistician
This book is intended for anyone who is considering a career in statistics or a related field, or those at any point in their career with sufficient work time remaining such that investing in additional learning could be beneficial. As such, the book would be suitable for anyone pursing an MS or PhD in statistics or those already working in statistics. The book focuses on the non-statistical aspects of being a statistician that are crucial for success. These factors include 1) productivity and prioritization, 2) innovation and creativity, 3) communication, 4) critical thinking and decisions under uncertainty, 5) influence and leadership, 6) working relationships, and 7) career planning and c...
Principles and Practice of Clinical Trials
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 po...
Practical Considerations for Adaptive Trial Design and Implementation
This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical ...
Missing Data in Clinical Studies
Missing Data in Clinical Studies provides a comprehensive account of the problems arising when data from clinical and related studies are incomplete, and presents the reader with approaches to effectively address them. The text provides a critique of conventional and simple methods before moving on to discuss more advanced approaches. The authors focus on practical and modeling concepts, providing an extensive set of case studies to illustrate the problems described. Provides a practical guide to the analysis of clinical trials and related studies with missing data. Examines the problems caused by missing data, enabling a complete understanding of how to overcome them. Presents conventional,...
Handbook of Missing Data Methodology
Missing data affect nearly every discipline by complicating the statistical analysis of collected data. But since the 1990s, there have been important developments in the statistical methodology for handling missing data. Written by renowned statisticians in this area, Handbook of Missing Data Methodology presents many methodological advances and the latest applications of missing data methods in empirical research. Divided into six parts, the handbook begins by establishing notation and terminology. It reviews the general taxonomy of missing data mechanisms and their implications for analysis and offers a historical perspective on early methods for handling missing data. The following three...
Cancer on Trial
There were no medical oncologists until a few decades ago. In the early 1960s, not only were there no such specialists, many practitioners regarded the treatment of terminally-ill cancer patients with heroic courses of chemotherapy as highly questionable. Physicians loath to assign patients randomly to competing treatments also expressed their outright opposition to the randomized clinical trials that were then relatively rare. And yet today these trials form the basis of medical oncology. How did such a spectacular change occur? How did medical oncology move from a non-entity and in some regards a reviled practice to the central position it now occupies in modern medicine?"Cancer on Trial"answers these questions by exploring how practitioners established a new style of practice, at the center of which lies the cancer clinical trial."
Clinical Trials
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detail...
