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The Burden of Female Talent
Widely considered the preeminent Chinese woman poet, Li Qingzhao (1084-1150s) occupies a crucial place in China’s literary and cultural history. She stands out as the great exception to the rule that the first-rank poets in premodern China were male. But at what price to our understanding of her as a writer does this distinction come? The Burden of Female Talent challenges conventional modes of thinking about Li Qingzhao as a devoted but often lonely wife and, later, a forlorn widow. By examining manipulations of her image by the critical tradition in later imperial times and into the twentieth century, Ronald C. Egan brings to light the ways in which critics sought to accommodate her to c...
Advanced Statistics in Regulatory Critical Clinical Initiatives
Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, ph...
Design and Analysis of Pragmatic Trials
This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that need to be addressed by statisticians at the design stage. It discusses the advantages and disadvantages of each type of PCT, and provides sample size formulas, sensitivity analyses, and examples for sample size calculation. The generalized estimating equation (GEE) method will be employed to derive sample size formulas for various types of outcomes from the exponential family, including continuous, binary, and count variables. Experimental designs that have been frequently employed in PCTs will be discussed, including cluster randomized designs, matched-pair cluster ...
Data Science, AI, and Machine Learning in Drug Development
The confluence of big data, artificial intelligence (AI), and machine learning (ML) has led to a paradigm shift in how innovative medicines are developed and healthcare delivered. To fully capitalize on these technological advances, it is essential to systematically harness data from diverse sources and leverage digital technologies and advanced analytics to enable data-driven decisions. Data science stands at a unique moment of opportunity to lead such a transformative change. Intended to be a single source of information, Data Science, AI, and Machine Learning in Drug Research and Development covers a wide range of topics on the changing landscape of drug R & D, emerging applications of bi...
Statistical Analytics for Health Data Science with SAS and R
This book aims to compile typical fundamental-to-advanced statistical methods to be used for health data sciences. Although the book promotes applications to health and health-related data, the models in the book can be used to analyze any kind of data. The data are analyzed with the commonly used statistical software of R/SAS (with online supplementary on SPSS/Stata). The data and computing programs will be available to facilitate readers’ learning experience. There has been considerable attention to making statistical methods and analytics available to health data science researchers and students. This book brings it all together to provide a concise point-of-reference for the most commo...
Model-Assisted Bayesian Designs for Dose Finding and Optimization
Bayesian adaptive designs provide a critical approach to improve the efficiency and success of drug development that has been embraced by the US Food and Drug Administration (FDA). This is particularly important for early phase trials as they form the basis for the development and success of subsequent phase II and III trials. The objective of this book is to describe the state-of-the-art model-assisted designs to facilitate and accelerate the use of novel adaptive designs for early phase clinical trials. Model-assisted designs possess avant-garde features where superiority meets simplicity. Model-assisted designs enjoy exceptional performance comparable to more complicated model-based adapt...
Medical Statistics for Cancer Studies
Cancer is a dreaded disease. One in two people will be diagnosed with cancer within their lifetime. Medical Statistics for Cancer Studies shows how cancer data can be analysed in a variety of ways, covering cancer clinical trial data, epidemiological data, biological data, and genetic data. It gives some background in cancer biology and genetics, followed by detailed overviews of survival analysis, clinical trials, regression analysis, epidemiology, meta-analysis, biomarkers, and cancer informatics. It includes lots of examples using real data from the author’s many years of experience working in a cancer clinical trials unit. Features: A broad and accessible overview of statistical methods in cancer research Necessary background in cancer biology and genetics Details of statistical methodology with minimal algebra Many examples using real data from cancer clinical trials Appendix giving statistics revision.
Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials
Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials provides a practical introduction to unconditional approaches to planning randomised clinical trials, particularly aimed at drug development in the pharmaceutical industry. This book is aimed at providing guidance to practitioners in using average power, assurance and related concepts. This book brings together recent research and sets them in a consistent framework and provides a fresh insight into how such methods can be used. Features: A focus on normal theory linking average power, expected power, predictive power, assurance, conditional Bayesian power and Bayesian power. Extensions of the concepts to binomi...
Digital Therapeutics
One of the hallmarks of the 21st century medicine is the emergence of digital therapeutics (DTx)—evidence-based, clinically validated digital technologies to prevent, diagnose, treat, and manage various diseases and medical conditions. DTx solutions have been gaining interest from patients, investors, healthcare providers, health authorities, and other stakeholders because of the potential of DTx to deliver equitable, massively scalable, personalized and transformative treatments for different unmet medical needs. Digital Therapeutics: Scientific, Statistical, Clinical, and Regulatory Aspects is an unparalleled summary of the current scientific, statistical, developmental, and regulatory a...
Microbial Biofilms
This book provides a broad range of applications and recent advances in the search for biofilm materials in nature. It also explains the future implications for biofilms in the areas of advanced molecular genetics, pharmaceuticals, pharmacology, and toxicology. This book is comprised of 20 chapters from leading experts in the field and it examines immunology and microbiological studies derived from biofilms as well as explores environmental, agricultural, and chemical impacts on biofilms. It is divided into five subdivisions: biofilms and its complications, biofilm infections in human body, detection of biofilm-forming pathogens, antibiofilm chemotherapy, and biofilms production tools in aqu...
