Beschreibung
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.
Autorenportrait
InhaltsangabeForeword xix Preface xxi Editors xxiii Contributors xxv Part One STATISTICS IN THE DEVELOPMENT OF PHARMACEUTICAL PRODUCTS 1 Statistical Aspects in ICH, FDA and EMA Guidelines 3 Allan Sampson and Ron S. Kenett Synopsis 3 References 19 2 Statistical Methods in Clinical Trials 22 Telba Irony, Caiyan Li and Phyllis Silverman Synopsis 22 References 54 Further Reading 54 3 Pharmacometrics in Drug Development 56 Serge Guzy and Robert Bauer Synopsis 56 4 Interactive Clinical Trial Design 78 Zvia Agur Synopsis 78 Adaptive Clinical Trial Design Methods 99 Acknowledgements 100 References 100 5 Stagewise Clinical Trial Experiments in Phases I, II and III 103 Shelemyahu Zacks Synopsis 103 References 120 6 Risk Management in Drug Manufacturing and Healthcare 122 Ron S. Kenett Synopsis 122 References 152 7 The Twentyfirst Century Challenges in Drug Development 155 Yafit Stark Synopsis 155 References 166 Part Two STATISTICS IN OUTCOMES ANALYSIS 8 The Issue of Bias in Combined Modelling and Monitoring of Health Outcomes 169 Olivia A. J. Grigg Synopsis 169 References 182 9 Disease Mapping 185 Annibale Biggeri and Dolores Catelan Synopsis 185 References 210 10 Process Indicators and Outcome Measures in the Treatment of Acute Myocardial Infarction Patients 219 Alessandra Guglielmi, Francesca Ieva, Anna Maria Paganoni and Fabrizio Ruggeri Synopsis 219 References 228 11 Metaanalysis 230 Eva Negri Synopsis 230 References 247 Part Three STATISTICAL PROCESS CONTROL IN HEALTHCARE 12 The Use of Control Charts in Healthcare 253 William H. Woodall, Benjamin M. Adams and James C. Benneyan Synopsis 253 Acknowledgements 265 References 265 13 Common Challenges and Pitfalls Using SPC in Healthcare 268 Victoria Jordan and James C. Benneyan Synopsis 268 References 285 14 Six Sigma in Healthcare 286 Shirley Y. Coleman Synopsis 286 References 307 15 Statistical Process Control in Clinical Medicine 309 Per Winkel and Nien Fan Zhang Synopsis 309 Appendix A 328 15.A.1 The EWMA Chart 328 15.A.2 Logistic Regression 329 15.A.3 Autocovariance and Autocorrelation 330 Acknowledgements 330 References 330 Part Four APPLICATIONS TO HEALTHCARE POLICY AND IMPLEMENTATION 16 Modeling Kidney Allocation: A Data-driven Optimization Approach 335 Inbal Yahav Synopsis 335 Acknowledgement 352 References 352 17 Statistical Issues in Vaccine Safety Evaluation 353 Patrick Musonda Synopsis 353 References 362 18 Statistical Methods for Healthcare Economic Evaluation 365 Caterina Conigliani, Andrea Manca and Andrea Tancredi Synopsis 365 References 383 19 Costing and Performance in Healthcare Management 386 Rosanna Tarricone and Aleksandra Torbica Synopsis 386 References 403 Part Five APPLICATIONS TO HEALTHCARE MANAGEMENT 20 Statistical Issues in Healthcare Facilities Management 407 Daniel P. O'Neill and Anja Drescher Synopsis 407 References 425 21 Simulation for Improving Healthcare Service Management 426 Anne Shade Synopsis 426 References 444 22 Statistical Issues in Insurance/payor Processes 445 Melissa Popkoski Synopsis 445 Reference 455 23 Quality of Electronic Medical Records 456 Dario Gregori and Paola Berchialla Synopsis 456 References 475 Index 481
Leseprobe
