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.

Statistical Methods in HealthcareIn 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.

Foreword xixPreface xxiEditors xxiiiContributors xxvPart One STATISTICS IN THE DEVELOPMENT OF PHARMACEUTICAL PRODUCTS1 Statistical Aspects in ICH, FDA and EMA Guidelines 3Allan Sampson and Ron S. Kenett2 Statistical Methods in Clinical Trials 22Telba Irony, Caiyan Li and Phyllis Silverman3 Pharmacometrics in Drug Development 56Serge Guzy and Robert Bauer4 Interactive Clinical Trial Design 78Zvia Agur5 Stage-wise Clinical Trial Experiments in Phases I, II and III 103Shelemyahu Zacks6 Risk Management in Drug Manufacturing and Healthcare 122Ron S. Kenett7 The Twenty-first Century Challenges in Drug Development 155Yafit StarkPart Two STATISTICS IN OUTCOMES ANALYSIS8 The Issue of Bias in Combined Modelling and Monitoring of Health Outcomes 169Olivia A. J. Grigg9 Disease Mapping 185Annibale Biggeri and Dolores Catelan10 Process Indicators and Outcome Measures in the Treatment of Acute Myocardial Infarction Patients 219Alessandra Guglielmi, Francesca Ieva, Anna Maria Paganoni and Fabrizio Ruggeri11 Meta-analysis 230Eva NegriPart Three STATISTICAL PROCESS CONTROL IN HEALTHCARE12 The Use of Control Charts in Healthcare 253William H. Woodall, Benjamin M. Adams and James C. Benneyan13 Common Challenges and Pitfalls Using SPC in Healthcare 268Victoria Jordan and James C. Benneyan14 Six Sigma in Healthcare 286Shirley Y. Coleman15 Statistical Process Control in Clinical Medicine 309Per Winkel and Nien Fan ZhangPart Four APPLICATIONS TO HEALTHCARE POLICY AND IMPLEMENTATION16 Modeling Kidney Allocation: A Data-driven Optimization Approach 335Inbal Yahav17 Statistical Issues in Vaccine Safety Evaluation 353Patrick Musonda18 Statistical Methods for Healthcare Economic Evaluation 365Caterina Conigliani, Andrea Manca and Andrea Tancredi19 Costing and Performance in Healthcare Management 386Rosanna Tarricone and Aleksandra TorbicaPart Five APPLICATIONS TO HEALTHCARE MANAGEMENT20 Statistical Issues in Healthcare Facilities Management 407Daniel P. O'Neill and Anja Drescher21 Simulation for Improving Healthcare Service Management 426Anne Shade22 Statistical Issues in Insurance/payor Processes 445Melissa Popkoski23 Quality of Electronic Medical Records 456Dario Gregori and Paola BerchiallaReferences 475Index 481