Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients. This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients. The book covers: Theory, methods, applications, and computing Bayesian biostatistics for clinical innovative designs Adding value with Real World Evidence Opportunities for rare, orphan diseases, and pediatric development Applied Bayesian biostatistics in manufacturing Decision making and Portfolio management Regulatory perspective and public health policies Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research.

Survival Analysis with Interval-Censored Data: A Practical Approach with Examples in R, SAS, and BUGS provides the reader with a practical introduction into the analysis of interval-censored survival times. Although many theoretical developments have appeared in the last fifty years, interval censoring is often ignored in practice. Many are unaware of the impact of inappropriately dealing with interval censoring. In addition, the necessary software is at times difficult to trace. This book fills in the gap between theory and practice. Features: -Provides an overview of frequentist as well as Bayesian methods. -Include a focus on practical aspects and applications. -Extensively illustrates the methods with examples using R, SAS, and BUGS. Full programs are available on a supplementary website. The authors: Kris Bogaerts is project manager at I-BioStat, KU Leuven. He received his PhD in science (statistics) at KU Leuven on the analysis of interval-censored data. He has gained expertise in a great variety of statistical topics with a focus on the design and analysis of clinical trials. Arnost Komarek is associate professor of statistics at Charles University, Prague. His subject area of expertise covers mainly survival analysis with the emphasis on interval-censored data and classification based on longitudinal data. He is past chair of the Statistical Modelling Society and editor of Statistical Modelling: An International Journal. Emmanuel Lesaffre is professor of biostatistics at I-BioStat, KU Leuven. His research interests include Bayesian methods, longitudinal data analysis, statistical modelling, analysis of dental data, interval-censored data, misclassification issues, and clinical trials. He is the founding chair of the Statistical Modelling Society, past-president of the International Society for Clinical Biostatistics, and fellow of ISI and ASA.

Survival Analysis with Interval-Censored Data: A Practical Approach with Examples in R, SAS, and BUGS provides the reader with a practical introduction into the analysis of interval-censored survival times. Although many theoretical developments have appeared in the last fifty years, interval censoring is often ignored in practice. Many are unaware of the impact of inappropriately dealing with interval censoring. In addition, the necessary software is at times difficult to trace. This book fills in the gap between theory and practice. Features: -Provides an overview of frequentist as well as Bayesian methods. -Include a focus on practical aspects and applications. -Extensively illustrates the methods with examples using R, SAS, and BUGS. Full programs are available on a supplementary website. The authors: Kris Bogaerts is project manager at I-BioStat, KU Leuven. He received his PhD in science (statistics) at KU Leuven on the analysis of interval-censored data. He has gained expertise in a great variety of statistical topics with a focus on the design and analysis of clinical trials. Arnost Komarek is associate professor of statistics at Charles University, Prague. His subject area of expertise covers mainly survival analysis with the emphasis on interval-censored data and classification based on longitudinal data. He is past chair of the Statistical Modelling Society and editor of Statistical Modelling: An International Journal. Emmanuel Lesaffre is professor of biostatistics at I-BioStat, KU Leuven. His research interests include Bayesian methods, longitudinal data analysis, statistical modelling, analysis of dental data, interval-censored data, misclassification issues, and clinical trials. He is the founding chair of the Statistical Modelling Society, past-president of the International Society for Clinical Biostatistics, and fellow of ISI and ASA.

It is imperative that health professionals caring for patients with rheumatic diseases understand how to correctly interpret evidence in their field, taking into account the merits and shortcomings of available data. Understanding Evidence-Based Rheumatology offers a practical assessment of criteria, drugs, trials, and registries and provides useful tools for successfully interpreting this data. The book introduces readers to basic analysis of trial design, statistics and application of data through no-nonsense, easy-to-follow insights. Using numerous examples, chapters outline the difficulties physicians encounter when measuring disease activity in rheumatology and offer strategies for systematically approaching these situations. Ethical issues in study design and reporting are examined and the book closes with a summary of future directions for scientific and clinical studies in rheumatology. Understanding Evidence-Based Rheumatology is an invaluable resource for trainees, clinicians and scientists, preparing them with the necessary tools to correctly gather evidence and shed light on the difficult practice of rheumatology.

It is imperative that health professionals caring for patients with rheumatic diseases understand how to correctly interpret evidence in their field, taking into account the merits and shortcomings of available data. "Understanding Evidence-Based Rheumatology"offers a practical assessment of criteria, drugs, trials, and registries and provides useful tools for successfully interpreting this data. The book introduces readers to basic analysis of trial design, statistics and application of data through no-nonsense, easy-to-follow insights. Using numerous examples, chapters outline the difficulties physicians encounter when measuring disease activity in rheumatology and offer strategies for systematically approaching these situations. Ethical issues in study design and reporting are examined and the book closes with a summary of future directions for scientific and clinical studies in rheumatology.

"Understanding Evidence-Based Rheumatology"is an invaluable resource for trainees, clinicians and scientists, preparing them with the necessary tools to correctly gather evidence and shed light on the difficult practice of rheumatology."

Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients. This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients. The book covers: Theory, methods, applications, and computing Bayesian biostatistics for clinical innovative designs Adding value with Real World Evidence Opportunities for rare, orphan diseases, and pediatric development Applied Bayesian biostatistics in manufacturing Decision making and Portfolio management Regulatory perspective and public health policies Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research.