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.
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. 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. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful.
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.
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.
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. 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. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful.
Everything pharmacists and pharmacy students need to know about drug information management A Doody's Core Title for 2023! Drug Information: A Guide for Pharmacists provides you with the tools you need to to research, interpret, evaluate, collate, and disseminate drug information in the most effective and efficient manner possible. This trusted resource addresses essential topics such as formulating an effective response and recommendations for information, evaluation of drug literature, the application of statistical analysis in the biomedical sciences, medications and patient safety, investigational drugs, and more. This updated seventh edition also addresses other important issues such as the legal and ethical considerations of providing information, how to respond to requests for information, and how to determine what information should be made available.
The new gold-standard in anesthesiology Written and edited by an internationally known team of experts, Anesthesiology gives you a 360-degree view of the field, covering all of the anesthetic considerations, preparations, and procedures for the surgical patient, the pain patient or the critical care patient. You'll find a unique balance between clinical information, practical clinical procedures, and the molecular and basic scientific underpinnings of anesthesiology practice. Anesthesiology delivers a multi-perspective, wide-ranging view of anesthetic drugs, procedures, co-morbid diseases, and need-to-know postoperative pain management strategies. This essential guide not only focuses on general anesthesia, but also is the first to feature a detailed look at the subspecialty of regional anesthesia. Features: Top-to-bottom coverage of the entire field-from preoperative evaluation and intraoperative anesthesia care to care of the critically ill or chronic pain patient Emphasis on safety, quality and patient-centered care, with an entire section on risk reduction A focus on the clinical applications of anesthesiology Complex concepts explained by graphics and illustrations, not equations and formulas Full-color format and illustrations Specific drug and interventional guidelines for the clinical management of every OR/post-OR scenario in the anesthesiology field Key points and key references presented in each chapter CD that allows you to download illustrations and images to your PowerPoint presentations
The ultimate guide to the evidence-based clinical encounter "This book is an excellent source of supported evidence that provides useful and clinically relevant information for the busy practitioner, student, resident, or educator who wants to hone skills of physical diagnosis. It provides a tool to improve patient care by using the history and physical examination items that have the most reliability and efficiency."--Annals of Internal Medicine "The evidence-based examination techniques put forth by Rational Clinical Examination is the sort that can be brought to bear on a daily basis – to save time, increase confidence in medical decisions, and help decrease unnecessary testing for conditions that do not require absolute diagnostic certainty. In the end, the whole of this book is greater than its parts and can serve as a worthy companion to a traditional manual of physical examination."--Baylor University Medical Center (BUMC)Proceedings 5 STAR DOODY'S REVIEW! "Physical diagnosis has been taught to every medical student but this evidence-based approach now shows us why, presenting one of medicine's most basic tenets in a new and challenging light. The format is extraordinary, taking previously published material and updating the pertinent evidence since the initial publication, affirming or questioning or refining the conclusions drawn from the data. "This is a book for everyone who has studied medicine and found themselves doubting what they have been taught over the years, not that they have been deluded, but that medical traditions have been unquestionably believed because there was no evidence to believe otherwise. The authors have uncovered the truth. "This extraordinary, one-of-a-kind book is a valuable addition to every medical library."--Doody's Review Service Completely updated with new literature analyses, here is a uniquely practical, clinically relevant approach to the use of evidence in the content of physical examination. Going far beyond the scope of traditional physical examination texts, this invaluable resource compiles and presents the evidence-based meanings of signs, symptoms, and results from physical examination maneuvers and other diagnostic studies. Page after page, you'll find a focus on actual clinical questions and presentations, making it an incomparably practical resource that you'll turn to again and again. Importantly, the high-yield content of The Rational Clinical Examination is significantly expanded and updated from the original JAMA articles, much of it published here for the first time. It all adds up to a definitive, ready-to-use clinical exam sourcebook that no student or clinician should be without. FEATURES Packed with updated, new, and previously unpublished information from the original JAMA articles Standardized template for every issue covered, including: Case Presentation; Why the Issue Is Clinically Important; Research and Statistical Methods Used to Find the Evidence Presented; The Sensitivity and Specificity of Each Key Result; Resolution of the Case Presentation; and the Clinical Bottom Line Completely updated with all-new literature searches and appraisals supplementing each chapter Full-color format with dynamic clinical illustrations and images Real-world focus on a specific clinical question in each chapter, reflecting the way clinicians approach the practice of evidence-based medicine More than 50 complete chapters on common and challenging clinical questions and patient presentations Also available: JAMAevidence.com, a new interactive database for the best practice of evidence based medicine
The world’s leading resource for to diagnosing and treating any injury—quickly, safely, and effectively Doody's Core Titles for 2023! Unparalleled in its breadth and depth of expertly crafted content, Trauma takes you through the full range of injuries you are likely to encounter. With a full-color atlas of anatomic drawings and surgical approaches, this trusted classic provides thorough coverage of kinematics and the mechanisms of trauma injury, the epidemiology of trauma, injury prevention, the basics of trauma systems, triage, and transport, and more. It then reviews generalized approaches to the trauma patient, from pre-hospital care and managing shock, to emergency department thoracotomy and the management of infections; delivers a clear, organ-by-organ survey of treatment protocols; and shows how to handle specific challenges in trauma―including alcohol and drug abuse, and combat-related wounds―in addition to post-traumatic complications such as multiple organ failure. 500 photos and illustrations Color atlas Numerous X-rays, CT scans, and algorithms High-yield section on specific approaches to the trauma patient A-to-Z overview of management of specific traumatic injuries Detailed discussion of the management of complications
The clinical trial is “the most definitive tool for evaluation of the applicability of clinical research.” It represents “a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments” [1]. It has been called on many occasions, “the gold st- dard” against which all other clinical research is measured. Although many clinical trials are of high quality, a careful reader of the medical literature will notice that a large number have deficiencies in design, conduct, analysis, presentation, and/or interpretation of results. Improvements have occurred over the past few decades, but too many trials are still conducted without adequate attention to its fundamental principles. Certainly, numerous studies could have been upgraded if the authors had had a better understanding of the fundamentals. Since the publication of the first edition of this book, a large number of other texts on clinical trials have appeared, most of which are indicated here [2–21]. Several of them, however, discuss only specific issues involved in clinical trials. Additionally, many are no longer current. The purpose of this fourth edition is to update areas in which major progress has been made since the publication of the third edition. We have revised most chapters considerably and added one on ethical issues.
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.
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.
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