Statistical Methods for Drug Safety

Gibbons and Amatya's book Statistical Methods for Drug Safety provides an overview of the core statistical methodology used in pharmacoepidemiology and drug safety. The authors draw on considerable experience in drug safety research to describe many of the key methods used in this field. The book is directed at two distinct groups of readers: statisticians with a good grasp of core concepts in applied statistics who are interested in pharmacoepidemiology, and pharmacoepidemiologists with a strong quantitative background who wish to learn more about the statistical tools in use in the field. Chapter 2 leads off with an overview of core statistical concepts used in epidemiology and clinical research. This brief section is very well done and helps orient the broad readership with a common language. This section would be helpful for either a nonstatistician needing an overview or for a statistician unfamiliar with some of the epidemiology-specific concepts used in the field. ... The book is technically quite detailed and provides a solid grounding on each of the tools used. Many of the chapters could stand alone as a solid introduction to the area in question. .... This book would be a useful addition to the library of a drug safety researcher, whether a statistician or an epidemiologist, who is interested in the statistical methods underlying the field. -Robert W. Platt, McGill University, in The American Statistician, October 2017 With the growing emphasis and regulation of product safety evaluation and benefit-risk evaluation, the publication of this safety statistics book has been a great addition to the Chapman and Hall/CRC biostatistics series in 2015. Comparing to the other well-written books on quantitative evaluation of drug safety, this book focuses on the advanced statistical methodologies and practice in pharmacoepidemiologic problems. The book covers a wide variety of statistical methodologies to various types of drug safety data, including spontaneous adverse event reporting database, medical claim database, longitudinal observational studies, and randomized clinical trials (RCTs). Throughout these book chapters, real case studies on the safety evaluation, for which authors either have served as a statistical consultation or have done applied methodology research, have been used to illustrate the relevant methods. Their real experiences with their humorous and story-telling styles have made the reading captivating....Drug safety evaluation is becoming an international and increasingly important priority. As Bob Oneil pointed out, statistical methodology for safety monitoring has not been well developed to match that for efficacy. This book provides a great resource for a wide variety of statistical methods that are useful for pharmacoepidemiologists and safety physicians in their work. It should also motivate biostatisticians to innovate and contribute to this important field. -William Wang in Journal of Biopharmaceutical Statistics, September 2016 Gibbons and Amatya's book Statistical Methods for Drug Safety provides an overview of the core statistical methodology used in pharmacoepidemiology and drug safety. The authors draw on considerable experience in drug safety research to describe many of the key methods used in this field. The book is directed at two distinct groups of readers: statisticians with a good grasp of core concepts in applied statistics who are interested in pharmacoepidemiology, and pharmacoepidemiologists with a strong quantitative background who wish to learn more about the statistical tools in use in the field. Chapter 2 leads off with an overview of core statistical concepts used in epidemiology and clinical research. This brief section is very well done and helps orient the broad readership with a common language. This section would be helpful for either a nonstatistician needing an overview or for a statistician unfamiliar with some of the epidemiology-specific concepts used in the field. ... The book is technically quite detailed and provides a solid grounding on each of the tools used. Many of the chapters could stand alone as a solid introduction to the area in question. .... This book would be a useful addition to the library of a drug safety researcher, whether a statistician or an epidemiologist, who is interested in the statistical methods underlying the field. -Robert W. Platt, McGill University, in The American Statistician, October 2017 With the growing emphasis and regulation of product safety evaluation and benefit-risk evaluation, the publication of this safety statistics book has been a great addition to the Chapman and Hall/CRC biostatistics series in 2015. Comparing to the other well-written books on quantitative evaluation of drug safety, this book focuses on the advanced statistical methodologies and practice in pharmacoepidemiologic problems. The book covers a wide variety of statistical methodologies to various types of drug safety data, including spontaneous adverse event reporting database, medical claim database, longitudinal observational studies, and randomized clinical trials (RCTs). Throughout these book chapters, real case studies on the safety evaluation, for which authors either have served as a statistical consultation or have done applied methodology research, have been used to illustrate the relevant methods. Their real experiences with their humorous and story-telling styles have made the reading captivating....Drug safety evaluation is becoming an international and increasingly important priority. As Bob Oneil pointed out, statistical methodology for safety monitoring has not been well developed to match that for efficacy. This book provides a great resource for a wide variety of statistical methods that are useful for pharmacoepidemiologists and safety physicians in their work. It should also motivate biostatisticians to innovate and contribute to this important field. -William Wang in Journal of Biopharmaceutical Statistics, September 2016