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Author: Paul Rosenbaum
Publisher: Harvard University Press
ISBN: 067497557X
Category : Mathematics
Languages : en
Pages : 395
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Book Description
A daily glass of wine prolongs life—yet alcohol can cause life-threatening cancer. Some say raising the minimum wage will decrease inequality while others say it increases unemployment. Scientists once confidently claimed that hormone replacement therapy reduced the risk of heart disease but now they equally confidently claim it raises that risk. What should we make of this endless barrage of conflicting claims? Observation and Experiment is an introduction to causal inference by one of the field’s leading scholars. An award-winning professor at Wharton, Paul Rosenbaum explains key concepts and methods through lively examples that make abstract principles accessible. He draws his examples from clinical medicine, economics, public health, epidemiology, clinical psychology, and psychiatry to explain how randomized control trials are conceived and designed, how they differ from observational studies, and what techniques are available to mitigate their bias. “Carefully and precisely written...reflecting superb statistical understanding, all communicated with the skill of a master teacher.” —Stephen M. Stigler, author of The Seven Pillars of Statistical Wisdom “An excellent introduction...Well-written and thoughtful...from one of causal inference’s noted experts.” —Journal of the American Statistical Association “Rosenbaum is a gifted expositor...an outstanding introduction to the topic for anyone who is interested in understanding the basic ideas and approaches to causal inference.” —Psychometrika “A very valuable contribution...Highly recommended.” —International Statistical Review
Author: Paul Rosenbaum
Publisher: Harvard University Press
ISBN: 067497557X
Category : Mathematics
Languages : en
Pages : 395
Get Book Here
Book Description
A daily glass of wine prolongs life—yet alcohol can cause life-threatening cancer. Some say raising the minimum wage will decrease inequality while others say it increases unemployment. Scientists once confidently claimed that hormone replacement therapy reduced the risk of heart disease but now they equally confidently claim it raises that risk. What should we make of this endless barrage of conflicting claims? Observation and Experiment is an introduction to causal inference by one of the field’s leading scholars. An award-winning professor at Wharton, Paul Rosenbaum explains key concepts and methods through lively examples that make abstract principles accessible. He draws his examples from clinical medicine, economics, public health, epidemiology, clinical psychology, and psychiatry to explain how randomized control trials are conceived and designed, how they differ from observational studies, and what techniques are available to mitigate their bias. “Carefully and precisely written...reflecting superb statistical understanding, all communicated with the skill of a master teacher.” —Stephen M. Stigler, author of The Seven Pillars of Statistical Wisdom “An excellent introduction...Well-written and thoughtful...from one of causal inference’s noted experts.” —Journal of the American Statistical Association “Rosenbaum is a gifted expositor...an outstanding introduction to the topic for anyone who is interested in understanding the basic ideas and approaches to causal inference.” —Psychometrika “A very valuable contribution...Highly recommended.” —International Statistical Review
Author: National Research Council
Publisher: National Academies Press
ISBN: 030918651X
Category : Medical
Languages : en
Pages : 163
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Book Description
Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309225493
Category : Medical
Languages : en
Pages : 432
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Book Description
The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Author: National Research Council (U.S.). Division of Medical Sciences
Publisher:
ISBN:
Category : Drug labeling
Languages : en
Pages : 0
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Book Description
Author:
Publisher:
ISBN:
Category : Boats and boating
Languages : en
Pages : 44
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Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309171148
Category : Medical
Languages : en
Pages : 221
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Book Description
Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
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Author: Paul A.. Bryan
Publisher:
ISBN:
Category :
Languages : en
Pages : 4
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Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
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Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
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Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author: National Research Council (U.S.). Division of Medical Sciences
Publisher:
ISBN:
Category :
Languages : en
Pages : 250
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Book Description
