Evaluating Clinical Research [electronic resource] : All that glitters is not gold /
Furberg, Bengt D.author.
Furberg, Curt D.author.
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.
Description based upon print version of record.
Includes bibliographical references (p. 149-158) and index.
What is the purpose of this book? -- Why is benefit-to-harm balance essential to treatment decisions? -- What are the strengths of randomized controlled clinical trials? -- What are the weaknesses of randomized controlled clinical trials? -- Do meta-analyses provide the ultimate truth? -- What are the strengths of observational studies? -- What are the weaknesses of observational studies? -- Were the scientific questions stated in advance? -- Were the treatment groups comparable initially? -- Why is blinding/masking so important? -- How is symptomatic improvement measured? -- Is it really possible to assess quality of life? -- What is the value of biologic markers in drug evaluation? -- How are adverse drug reactions measured? -- How representative are study subjects in clinical trials? -- What happened to the study subjects who disappeared from the analysis? -- How reliable are active-control trials? -- How informative are composite outcomes? -- Do changes in biologic markers predict clinical benefit? -- How trustworthy are the authors? -- Does publication in a reputable scientific journal guarantee quality? -- Is it necessary to be a biostatistician to interpret scientific data? -- Are all drugs of a class interchangeable? -- How much confidence can be placed on economic analysis? -- How should I handle the massive flow of information? -- How well is research translated into clinical care?.
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.
Statistics .
Medical research.
Pharmacology.
Statistics for Life Sciences, Medicine, Health Sciences.
Quality of Life Research.
Pharmacology/Toxicology.