Description
Book Synopsis* Provides a comprehensive, in-depth treatment of statistical methods in healthcare. * Presents 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.
Table of ContentsForeword 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
2 Statistical Methods in Clinical Trials 22
Telba Irony, Caiyan Li and Phyllis Silverman
3 Pharmacometrics in Drug Development 56
Serge Guzy and Robert Bauer
4 Interactive Clinical Trial Design 78
Zvia Agur
5 Stage-wise Clinical Trial Experiments in Phases I, II and III 103
Shelemyahu Zacks
6 Risk Management in Drug Manufacturing and Healthcare 122
Ron S. Kenett
7 The Twenty-first Century Challenges in Drug Development 155
Yafit Stark
Part Two STATISTICS IN OUTCOMES ANALYSIS
8 The Issue of Bias in Combined Modelling and Monitoring of Health Outcomes 169
Olivia A. J. Grigg
9 Disease Mapping 185
Annibale Biggeri and Dolores Catelan
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
11 Meta-analysis 230
Eva Negri
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
13 Common Challenges and Pitfalls Using SPC in Healthcare 268
Victoria Jordan and James C. Benneyan
14 Six Sigma in Healthcare 286
Shirley Y. Coleman
15 Statistical Process Control in Clinical Medicine 309
Per Winkel and Nien Fan Zhang
Part Four APPLICATIONS TO HEALTHCARE POLICY AND IMPLEMENTATION
16 Modeling Kidney Allocation: A Data-driven Optimization Approach 335
Inbal Yahav
17 Statistical Issues in Vaccine Safety Evaluation 353
Patrick Musonda
18 Statistical Methods for Healthcare Economic Evaluation 365
Caterina Conigliani, Andrea Manca and Andrea Tancredi
19 Costing and Performance in Healthcare Management 386
Rosanna Tarricone and Aleksandra Torbica
Part Five APPLICATIONS TO HEALTHCARE MANAGEMENT
20 Statistical Issues in Healthcare Facilities Management 407
Daniel P. O'Neill and Anja Drescher
21 Simulation for Improving Healthcare Service Management 426
Anne Shade
22 Statistical Issues in Insurance/payor Processes 445
Melissa Popkoski
23 Quality of Electronic Medical Records 456
Dario Gregori and Paola Berchialla
References 475
Index 481
