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The objective of this book is to make its readers better informed and more critical consumers of clinical research to help them recognize the strengths and the weaknesses of scientific publications. In doing so, the reader will be able to distinguish patient-important and methodologically sound studies from those having limitations in design, conduct and interpretation. There are no prerequisites for reading this book. The text is basic and has no statistical formulas. Key take-home messages are listed at the end of each chapter. The large number of cartoons has two purposes: First, to make the text easier to read and generate a few laughs and, second, to underscore specific points, sometimes in a provocative way. Bengt D. Furberg, MD, PhD is board-certified in internal medicine. After spending a decade as medical director in the pharmaceutical industry, he now serves as medical consultant, evaluating the safety and efficacy of pharmaceutical products and medical devices and promoting evidence-based medicine. His brother, Curt D. Furberg, MD, PhD, is Professor in the Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, USA. After arriving in the United States from Sweden, he worked at the National Heart, Lung, and Blood Institute of the National Institutes of Health for 12 years. He is co-author of Fundamentals of Clinical Trials with Lawrence M. Friedman and David L. DeMets. His areas of interest are clinical trials, evidence-based medicine and drug safety. The authors have acquired much of their knowledge about clinical studies through the "trial and error" method. Thus, they have personal experience with many of the problems they describe.

Clinical medicine --- Clinical trials. --- Medicine --- Research. --- Biomedical research --- Medical research --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Human experimentation in medicine --- Research --- Statistics. --- Quality of Life --- Toxicology. --- Statistics for Life Sciences, Medicine, Health Sciences. --- Quality of Life Research. --- Pharmacology/Toxicology. --- Chemicals --- Pharmacology --- Poisoning --- Poisons --- Life, Quality of --- Economic history --- Human ecology --- Life --- Social history --- Basic needs --- Human comfort --- Social accounting --- Work-life balance --- Statistical analysis --- Statistical data --- Statistical methods --- Statistical science --- Mathematics --- Econometrics --- Toxicology --- Statistics . --- Medical research. --- Pharmacology. --- Drug effects --- Medical pharmacology --- Medical sciences --- Chemotherapy --- Drugs --- Pharmacy --- Physiological effect

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Randomized clinical trials are the gold standard for establishing many clinical practice guidelines and are central to evidence based medicine. Obtaining the best evidence through clinical trials must be done within the boundaries of rigorous science and ethical principles. One fundamental principle is that trials should not continue longer than necessary to reach their objectives. Therefore, trials must be monitored for recruitment progress, quality of data, adherence to patient care or prevention standards, and early evidence of benefit or harm. Frequently, a group of external experts, independent from the investigators and trial sponsor, is charged with this monitoring responsibility, especially for safety and early benefit. This group is referred to by various names, such as a data monitoring committee or a data and safety monitoring board. This book, through a series of case studies presented by many distinguished clinical trial experts, illustrates the complexity of this monitoring process. The editors provide an overview of the process and a summary of a multitude of the lessons learned from the cases presented. This book should be useful to anyone serving on a data and safety monitoring board, or planning to do so, for colleagues in academia, industry and governmental agencies, and for teaching students in biostatistics, epidemiology, clinical trials and medical ethics. No other text has as extensive a collection of cases which provide insight into the many issues, often conflicting, that must be examined before recommendations to continue or discontinue a trial can be made. While depth in statistical methods is not required, some familiarity with statistical design and analysis issues in clinical trials is helpful. The cases cover trials which were terminated early for convincing evidence of benefit, or for harmful effects. Cases with complex issues are also included. This series of cases should provide broad background information for potential monitoring committee members and better prepare them for the challenges that may exist in the trials for which they are responsible. The three editors have contributed two overview chapters as well as several case studies to go along with cases contributed by a distinguished group of colleagues experienced in the design, monitoring and analysis of clinical trials. Dr. David DeMets is currently Professor and Chair, Department of Biostatistics and Medical Informatics at the University of Wisconsin-Madison. He is past president of the Eastern North American Region (ENAR) of the International Biometric Society, a past member of the Board of Directors of the American Statistical Association and an elected Fellow. He recently received the Robert Gordon Lectureship Award, given by the National Institutes of Health, for significant contributions to the field of clinical trials. Dr. Curt Furberg, is currently Professor (and former Chair) of the Department of Public Health Sciences at Wake Forest University. Previously, he was Head of the Clinical Trials Branch and Associate Director of the Clinical Applications and Prevention Program at the National Heart, Lung, and Blood Institute. Dr. Lawrence Friedman is a former Director of the Division of Epidemiology and Clinical Applications and a former Assistant Director for Ethics and Clinical Research at the National Heart, Lung, and Blood Institute. All three are past presidents of the Society of Clinical Trials. The editors have collaborated previously as coauthors of a text: the Fundamentals of Clinical Trials.

Biomathematics. Biometry. Biostatistics --- medische statistiek --- biostatistiek --- Clinical Trials --- Automatic Data Processing. --- Clinical trials --- Etudes cliniques --- Case Reports. --- Data processing. --- Case studies. --- Informatique --- Cas, Etudes de --- Clinical trials - Data processing. --- Controlled Clinical Trials as Topic --- Research --- Professional Staff Committees --- Clinical Trials as Topic --- Quality Assurance, Health Care --- Science --- Natural Science Disciplines --- Health Care Quality, Access, and Evaluation --- Epidemiologic Study Characteristics as Topic --- Evaluation Studies as Topic --- Health Care --- Epidemiologic Methods --- Disciplines and Occupations --- Health Care Evaluation Mechanisms --- Investigative Techniques --- Quality of Health Care --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Public Health --- Environment and Public Health --- Randomized Controlled Trials as Topic --- Biomedical Research --- Clinical Trials Data Monitoring Committees --- Mathematics --- Medicine --- Physical Sciences & Mathematics --- Health & Biological Sciences --- Mathematical Statistics --- Medical Research --- Data processing --- Statistics. --- Statistics for Life Sciences, Medicine, Health Sciences. --- Statistical analysis --- Statistical data --- Statistical methods --- Statistical science --- Econometrics --- Statistics .

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The objective of this book is to make its readers better informed and more critical consumers of clinical research to help them recognize the strengths and the weaknesses of scientific publications. In doing so, the reader will be able to distinguish patient-important and methodologically sound studies from those having limitations in design, conduct and interpretation. There are no prerequisites for reading this book. The text is basic and has no statistical formulas. Key take-home messages are listed at the end of each chapter. The large number of cartoons has two purposes: First, to make the text easier to read and generate a few laughs and, second, to underscore specific points, sometimes in a provocative way. Bengt D. Furberg, MD, PhD is board-certified in internal medicine. After spending a decade as medical director in the pharmaceutical industry, he now serves as medical consultant, evaluating the safety and efficacy of pharmaceutical products and medical devices and promoting evidence-based medicine. His brother, Curt D. Furberg, MD, PhD, is Professor in the Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, USA. After arriving in the United States from Sweden, he worked at the National Heart, Lung, and Blood Institute of the National Institutes of Health for 12 years. He is co-author of Fundamentals of Clinical Trials with Lawrence M. Friedman and David L. DeMets. His areas of interest are clinical trials, evidence-based medicine and drug safety. The authors have acquired much of their knowledge about clinical studies through the "trial and error" method. Thus, they have personal experience with many of the problems they describe.

Qualitative methods in social research --- Sociology --- Biomathematics. Biometry. Biostatistics --- Pharmacology. Therapy --- medische statistiek --- sociologie --- farmacologie --- biostatistiek --- toxicologie --- levenskwaliteit --- biometrie

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This is the fourth edition of a very successful textbook on clinical trials methodology, written by three recognized experts who have long and extensive experience in all areas of clinical trials. Most chapters have been revised considerably from the third edition. A chapter on ethics has been added and topics such as noninferiority and adaptive designs now receive considerable discussion. There is much new material on adverse events, adherence, data monitoring, and issues in analysis. 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 from a variety of medical disciplines 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. This book has been successfully used for teaching courses in clinical trial methodology.

Statistical science --- Biomathematics. Biometry. Biostatistics --- Hygiene. Public health. Protection --- Oncology. Neoplasms --- Epidemiology --- volksgezondheid --- medische statistiek --- biostatistiek --- statistiek --- oncologie --- epidemiologie

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