Table of Contents
Foreword 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 3Allan Sampson and Ron S. Kenett
2 Statistical Methods in Clinical Trials 22Telba Irony, Caiyan Li and Phyllis Silverman
3 Pharmacometrics in Drug Development 56Serge Guzy and Robert Bauer
4 Interactive Clinical Trial Design 78Zvia Agur
5 Stage-wise Clinical Trial Experiments in Phases I, II and III 103Shelemyahu Zacks
6 Risk Management in Drug Manufacturing and Healthcare 122Ron S. Kenett
7 The Twenty-first Century Challenges in Drug Development 155Yafit Stark
Part Two STATISTICS IN OUTCOMES ANALYSIS
8 The Issue of Bias in Combined Modelling and Monitoring of Health Outcomes 169Olivia A. J. Grigg
9 Disease Mapping 185Annibale Biggeri and Dolores Catelan
10 Process Indicators and Outcome Measures in the Treatment of Acute Myocardial Infarction Patients 219Alessandra Guglielmi, Francesca Ieva, Anna Maria Paganoni and Fabrizio Ruggeri
11 Meta-analysis 230Eva Negri
Part Three STATISTICAL PROCESS CONTROL IN HEALTHCARE
12 The Use of Control Charts in Healthcare 253William H. Woodall, Benjamin M. Adams and James C. Benneyan
13 Common Challenges and Pitfalls Using SPC in Healthcare 268Victoria Jordan and James C. Benneyan
14 Six Sigma in Healthcare 286Shirley Y. Coleman
15 Statistical Process Control in Clinical Medicine 309Per Winkel and Nien Fan Zhang
Part Four APPLICATIONS TO HEALTHCARE POLICY AND IMPLEMENTATION
16 Modeling Kidney Allocation: A Data-driven Optimization Approach 335Inbal Yahav
17 Statistical Issues in Vaccine Safety Evaluation 353Patrick Musonda
18 Statistical Methods for Healthcare Economic Evaluation 365Caterina Conigliani, Andrea Manca and Andrea Tancredi
19 Costing and Performance in Healthcare Management 386Rosanna Tarricone and Aleksandra Torbica
Part Five APPLICATIONS TO HEALTHCARE MANAGEMENT
20 Statistical Issues in Healthcare Facilities Management 407Daniel P. O'Neill and Anja Drescher
21 Simulation for Improving Healthcare Service Management 426Anne Shade
22 Statistical Issues in Insurance/payor Processes 445Melissa Popkoski
23 Quality of Electronic Medical Records 456Dario Gregori and Paola Berchialla
References 475
Index 481