The book brings together experts working in public health and multi-disciplinary areas to present recent issues in statistical methodological development and their applications. This timely book will impact model development and data analyses of public health research across a wide spectrum of analysis. Data and software used in the studies are available for the reader to replicate the models and outcomes. The fifteen chapters range in focus from techniques for dealing with missing data with Bayesian estimation, health surveillance and population definition and implications in applied latent class analysis, to multiple comparison and meta-analysis in public health data. Researchers in biomedical and public health research will find this book to be a useful reference and it can be used in graduate level classes.

Statistical Methods in Healthcare In recent years the number of innovative medicinal products and devices submitted and approved by regulatory bodies has declined dramatically. The medical product development process is no longer able to keep pace with increasing technologies, science and innovations and the goal is to develop new scientific and technical tools and to make product development processes more efficient and effective. Statistical Methods in Healthcare focuses on the application of statistical methodologies to evaluate promising alternatives and to optimize the performance and demonstrate the effectiveness of those that warrant pursuit is critical to success. Statistical methods used in planning, delivering and monitoring health care, as well as selected statistical aspects of the development and/or production of pharmaceuticals and medical devices are also addressed. With a focus on finding solutions to these challenges, this book: Provides a comprehensive, in-depth treatment of statistical methods in healthcare, along with a reference source for practitioners and specialists in health care and drug development. Offers a broad coverage of standards and established methods through leading edge techniques. Uses an integrated case study based approach, with focus on applications. Looks at the use of analytical and monitoring schemes to evaluate therapeutic performance. Features the application of modern quality management systems to clinical practice, and to pharmaceutical development and production processes. Addresses the use of modern statistical methods such as Adaptive Design, Seamless Design, Data Mining, Bayesian networks and Bootstrapping that can be applied to support the challenging new vision. Practitioners in healthcare-related professions, ranging from clinical trials to care delivery to medical device design, as well as statistical researchers in the field, will benefit from this book.

This book examines statistical methods and models used in the fields of global health and epidemiology. It includes methods such as innovative probability sampling, data harmonization and encryption, and advanced descriptive, analytical and monitory methods. Program codes using R are included as well as real data examples. Contemporary global health and epidemiology involves a myriad of medical and health challenges, including inequality of treatment, the HIV/AIDS epidemic and its subsequent control, the flu, cancer, tobacco control, drug use, and environmental pollution. In addition to its vast scales and telescopic perspective; addressing global health concerns often involves examining resource-limited populations with large geographic, socioeconomic diversities. Therefore, advancing global health requires new epidemiological design, new data, and new methods for sampling, data processing, and statistical analysis. This book provides global health researchers with methods that will enable access to and utilization of existing data. Featuring contributions from both epidemiological and biostatistical scholars, this book is a practical resource for researchers, practitioners, and students in solving global health problems in research, education, training, and consultation.

Focusing on the statistical methods most frequently used in the health care literature and featuring numerous charts, graphs, and up-to-date examples from the literature, this text provides a thorough foundation for the statistics portion of nursing and all health care research courses. All Fifth Edition chapters include new examples and new computer printouts using the latest software, SPSS for Windows, Version 12. New material on regression diagnostics has been added.

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.

This book gathers invited presentations from the 2nd Symposium of the ICSA- CANADA Chapter held at the University of Calgary from August 4-6, 2015. The aim of this Symposium was to promote advanced statistical methods in big-data sciences and to allow researchers to exchange ideas on statistics and data science and to embraces the challenges and opportunities of statistics and data science in the modern world. It addresses diverse themes in advanced statistical analysis in big-data sciences, including methods for administrative data analysis, survival data analysis, missing data analysis, high-dimensional and genetic data analysis, longitudinal and functional data analysis, the design and analysis of studies with response-dependent and multi-phase designs, time series and robust statistics, statistical inference based on likelihood, empirical likelihood and estimating functions. The editorial group selected 14 high-quality presentations from this successful symposium and invited the presenters to prepare a full chapter for this book in order to disseminate the findings and promote further research collaborations in this area. This timely book offers new methods that impact advanced statistical model development in big-data sciences.

It is not news that each of us grows old. What is relatively new, however, is that the average age of the American population is increasing. More and better information is required to assess, plan for, and meet the needs of a graying population. The Aging Population in the Twenty-First Century examines social, economic, and demographic changes among the aged, as well as many health-related topics: health promotion and disease prevention; quality of life; health care system financing and use; and the quality of careâ€"especially long-term care. Recommendations for increasing and improving the data availableâ€"as well as for ensuring timely access to themâ€"are also included.

The book aims to provide both comprehensive reviews of the classical methods and an introduction to new developments in medical statistics. The topics range from meta analysis, clinical trial design, causal inference, personalized medicine to machine learning and next generation sequence analysis. Since the publication of the first edition, there have been tremendous advances in biostatistics and bioinformatics. The new edition tries to cover as many important emerging areas and reflect as much progress as possible. Many distinguished scholars, who greatly advanced their research areas in statistical methodology as well as practical applications, also have revised several chapters with relevant updates and written new ones from scratch.The new edition has been divided into four sections, including, Statistical Methods in Medicine and Epidemiology, Statistical Methods in Clinical Trials, Statistical Genetics, and General Methods. To reflect the rise of modern statistical genetics as one of the most fertile research areas since the publication of the first edition, the brand new section on Statistical Genetics includes entirely new chapters reflecting the state of the art in the field.Although tightly related, all the book chapters are self-contained and can be read independently. The book chapters intend to provide a convenient launch pad for readers interested in learning a specific topic, applying the related statistical methods in their scientific research and seeking the newest references for in-depth research.

This volume, representing a compilation of authoritative reviews on a multitude of uses of statistics in epidemiology and medical statistics written by internationally renowned experts, is addressed to statisticians working in biomedical and epidemiological fields who use statistical and quantitative methods in their work. While the use of statistics in these fields has a long and rich history, explosive growth of science in general and clinical and epidemiological sciences in particular have gone through a see of change, spawning the development of new methods and innovative adaptations of standard methods. Since the literature is highly scattered, the Editors have undertaken this humble exercise to document a representative collection of topics of broad interest to diverse users. The volume spans a cross section of standard topics oriented toward users in the current evolving field, as well as special topics in much need which have more recent origins. This volume was prepared especially keeping the applied statisticians in mind, emphasizing applications-oriented methods and techniques, including references to appropriate software when relevant.· Contributors are internationally renowned experts in their respective areas· Addresses emerging statistical challenges in epidemiological, biomedical, and pharmaceutical research· Methods for assessing Biomarkers, analysis of competing risks· Clinical trials including sequential and group sequential, crossover designs, cluster randomized, and adaptive designs· Structural equations modelling and longitudinal data analysis

"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.