Statistical Methods in Healthcare

• Year: 2012
• Tongue: English
• Leaves: 508
• Category: Library

✦ Synopsis

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 Healthcarefocuses 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.

Content:
Chapter 1 Statistical Aspects in ICH, FDA and EMA Guidelines (pages 1–21): Allan Sampson and Ron S. Kenett
Chapter 2 Statistical Methods in Clinical Trials (pages 22–55): Telba Irony, Caiyan Li and Phyllis Silverman
Chapter 3 Pharmacometrics in Drug Development (pages 56–77): Serge Guzy and Robert Bauer
Chapter 4 Interactive Clinical Trial Design (pages 78–102): Zvia Agur
Chapter 5 Stage?Wise Clinical Trial Experiments in Phases I, II and III (pages 103–121): Shelemyahu Zacks
Chapter 6 Risk Management in Drug Manufacturing and Healthcare (pages 122–154): Ron S. Kenett
Chapter 7 The Twenty?First Century Challenges in Drug Development (pages 155–166): Yafit Stark
Chapter 8 The Issue of Bias in Combined Modelling and Monitoring of Health Outcomes (pages 167–184): Olivia A. J. Grigg
Chapter 9 Disease Mapping (pages 185–218): Annibale Biggeri and Dolores Catelan
Chapter 10 Process Indicators and Outcome Measures in the Treatment of Acute Myocardial Infarction Patients (pages 219–229): Alessandra Guglielmi, Francesca Ieva, Anna Maria Paganoni and Fabrizio Ruggeri
Chapter 11 Meta?Analysis (pages 230–249): Eva Negri
Chapter 12 The Use of Control Charts in Healthcare (pages 251–267): William H. Woodall, Benjamin M. Adams and James C. Benneyan
Chapter 13 Common Challenges and Pitfalls Using SPC in Healthcare (pages 268–285): Victoria Jordan and James C. Benneyan
Chapter 14 Six Sigma in Healthcare (pages 286–308): Shirley Y. Coleman
Chapter 15 Statistical Process Control in Clinical Medicine (pages 309–331): Per Winkel and Nien Fan Zhang
Chapter 16 Modeling Kidney Allocation: A Data?Driven Optimization Approach (pages 333–352): Inbal Yahav
Chapter 17 Statistical Issues in Vaccine Safety Evaluation (pages 353–364): Patrick Musonda
Chapter 18 Statistical Methods for Healthcare Economic Evaluation (pages 365–385): Caterina Conigliani, Andrea Manca and Andrea Tancredi
Chapter 19 Costing and Performance in Healthcare Management (pages 386–404): Rosanna Tarricone and Aleksandra Torbica
Chapter 20 Statistical Issues in Healthcare Facilities Management (pages 405–425): Daniel P. O'Neill and Anja Drescher
Chapter 21 Simulation for Improving Healthcare Service Management (pages 426–444): Anne Shade
Chapter 22 Statistical Issues in Insurance/Payor Processes (pages 445–455): Melissa Popkoski
Chapter 23 Quality of Electronic Medical Records (pages 456–480): Dario Gregori and Paola Berchialla