Ebook: evaluating clinical research: All that glitters is not gold

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.

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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.

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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.

Content:
Front Matter....Pages I-IV
What is the purpose of this book?....Pages 1-3
Why is benefit-to-harm balance essential to treatment decisions?....Pages 5-10
What are the strengths of randomized controlled clinical trials?....Pages 11-16
What are the weaknesses of randomized controlled clinical trials?....Pages 17-22
Do meta-analyses provide the ultimate truth?....Pages 23-28
What are the strengths of observational studies?....Pages 29-34
What are the weaknesses of observational studies?....Pages 35-37
Were the scientific questions stated in advance?....Pages 39-43
Were the treatment groups comparable initially?....Pages 45-48
Why is blinding/masking so important?....Pages 49-52
How is symptomatic improvement measured?....Pages 53-56
Is it really possible to assess quality of life?....Pages 57-60
What is the value of biologic markers in drug evaluation?....Pages 61-65
How are adverse drug reactions measured?....Pages 67-71
How representative are study subjects in clinical trials?....Pages 73-76
What happened to the study subjects who disappeared from the analysis?....Pages 77-81
How reliable are active-control trials?....Pages 83-88
How informative are composite outcomes?....Pages 89-93
Do changes in biologic markers predict clinical benefit?....Pages 95-98
How trustworthy are the authors?....Pages 99-102
Does publication in a reputable scientific journal guarantee quality?....Pages 103-106
Is it necessary to be a biostatistician to interpret scientific data?....Pages 107-113
Are all drugs of a class interchangeable?....Pages 115-119
How much confidence can be placed on economic analysis?....Pages 121-125
How should I handle the massive flow of information?....Pages 125-130
How well is research translated into clinical care?....Pages 131-135
Back Matter....Pages 137-158

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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.

Content:
Front Matter....Pages I-IV
What is the purpose of this book?....Pages 1-3
Why is benefit-to-harm balance essential to treatment decisions?....Pages 5-10
What are the strengths of randomized controlled clinical trials?....Pages 11-16
What are the weaknesses of randomized controlled clinical trials?....Pages 17-22
Do meta-analyses provide the ultimate truth?....Pages 23-28
What are the strengths of observational studies?....Pages 29-34
What are the weaknesses of observational studies?....Pages 35-37
Were the scientific questions stated in advance?....Pages 39-43
Were the treatment groups comparable initially?....Pages 45-48
Why is blinding/masking so important?....Pages 49-52
How is symptomatic improvement measured?....Pages 53-56
Is it really possible to assess quality of life?....Pages 57-60
What is the value of biologic markers in drug evaluation?....Pages 61-65
How are adverse drug reactions measured?....Pages 67-71
How representative are study subjects in clinical trials?....Pages 73-76
What happened to the study subjects who disappeared from the analysis?....Pages 77-81
How reliable are active-control trials?....Pages 83-88
How informative are composite outcomes?....Pages 89-93
Do changes in biologic markers predict clinical benefit?....Pages 95-98
How trustworthy are the authors?....Pages 99-102
Does publication in a reputable scientific journal guarantee quality?....Pages 103-106
Is it necessary to be a biostatistician to interpret scientific data?....Pages 107-113
Are all drugs of a class interchangeable?....Pages 115-119
How much confidence can be placed on economic analysis?....Pages 121-125
How should I handle the massive flow of information?....Pages 125-130
How well is research translated into clinical care?....Pages 131-135
Back Matter....Pages 137-158
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