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"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."

"This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. Most chapters have been revised considerably from the fourth edition. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals.The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives."

"The pace of therapeutic advances in the treatment of cardiovascular diseases is rapid, and new clinically–relevant information appears with such frequency that it can be extremely challenging for clinicians to keep up. Still, knowledge and interpretation of major clinical trials is crucial for the range of clinicians who manage cardiovascular patients, especially since important trial evidence often needs to be implemented soon after it is published. Confidently apply gold standard treatment for 10 of the most critical areas of cardiology Written by an international team of experts, Cardiovascular clinical trials : putting the evidence into practice, provides a succinct overview of recent major clinical trials, the gold standard for all medical treatment, across all the major cardiovascular subspecialties, to ensure you’re up–to–date on the most critical findings Guides cardiology trainees and clinicians on how cardiovascular clinical trials are designed and conducted, including statistical methodology."

"Summary:Critical appraisal is now accepted as central to the development of rational health care and evidence-based medicine, by applying it to questions of aetiology, clinical therapy, and health care management. The reader will learn how to assess the strengths and weaknesses of new studies, and how to conduct their own studies"

"At the end of world war II the allies faced a threefold challenge: how to punish perpetrators of appalling crimes for which the categories of genocide and crimes against humanity had to be coined; how to explain that these had been committed by Germany, of all nations; and how to reform Germans. The answer to this triple conundrum was the application of historical reasoning to legal procedure. In the Nuremberg trials held between 1945 and 1949, a concerted effort was made to punish key perpetrators while at the same time analysing the Nazi state and recounting German history. Building on a long debate about Germanys divergence from a presumed Western path of development, Allied prosecutors sketched out how Germany had betrayed the Western model. The prosecutors laid out how private enterprise, academic science, the military, and the civil service, which looked ostensibly similar to their opposite numbers in the Allied nations, had been corrupted in Germany even before Hitlers rise to power. While the argument, depending on individual protagonists, subject matters, and contexts, met with uneven success in court, it offered a final twist against the backdrop of the Cold War: although Germany had lost its way, it could still be brought back into the Western fold. The first comprehensive study of the Nuremberg trials, The Betrayal explores this process and sheds light on how history underpins transitional trials as we encounter them in todays courtrooms from Arusha to The Hague."