Methods and Applications of Statistics in Clinical Trials, Volume 2 (2014)

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* s  v& J- G* u! O/ F( d7 ITitle: Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods
( ~1 x5 w) I& k; ?: c* L+ nAuthor(s): N. Balakrishnan
5 `6 L0 f: u. qPublisher: Wiley
Year: 2014       
& b; \( i' Q! e$ B( nEdition: 1
/ |4 x9 a/ {- M+ z3 O! FLanguage: English
Pages: 960
( c% ^/ [8 z& i9 d' m8 ]" y% gISBN: 1118304764, 9781118304761
8 b- Z4 I) ^6 a0 t% KSize: 63 MB (65940955 bytes)       
Extension: pdf
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Description
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Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods includes updates of established literature from the Wiley Encyclopedia of Clinical Trials as well as original material based on the latest developments in clinical trials. Prepared by a leading expert, the second volume includes numerous contributions from current prominent experts in the field of medical research. In addition, the volume features:
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# E" F% C8 B" {* F/ ]. T5 C# f• Multiple new articles exploring emerging topics, such as evaluation methods with threshold, empirical likelihood methods, nonparametric ROC analysis, over- and under-dispersed models, and multi-armed bandit problems

• Up-to-date research on the Cox proportional hazard model, frailty models, trial reports, intrarater reliability, conditional power, and the kappa index
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9 {+ h6 P% [" D( A4 ^% F• Key qualitative issues including cost-effectiveness analysis, publication bias, and regulatory issues, which are crucial to the planning and data management of clinical trials

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Table of Contents
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Contributors xix

Preface xxiii

1 Analysis of Over- and Underdispersed Data 1
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2 Analysis of Variance (ANOVA) 10
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3 Assessment of Health-Related Quality of Life 26
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# a1 B* G8 r/ z7 ?4 Bandit Processes and Response-Adaptive Clinical Trials: The Art of Exploration Versus Exploitation 40

5 Bayesian Dose-Finding Designs in Healthy Volunteers 51

6 Bootstrap 62

7 Conditional Power in Clinical Trial Monitoring 102

8 Cost-Effectiveness Analysis 111
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/ Y2 L+ W' U$ \3 O9 Cox-Type Proportional Hazards Models 126

6 _1 b8 ?, ~/ z& Q6 v, x+ S* y. \10 Empirical Likelihood Methods in Clinical Experiments 146
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11 Frailty Models 166
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  Q- m! J% S2 b" ?  R12 Futility Analysis 174

5 L, O6 P: W0 n1 g13 Imaging Science in Medicine I: Overview 187
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/ E1 ?/ m/ |8 x9 ?( C9 H! [14 Imaging Science in Medicine, II: Basics of X-Ray Imaging 213
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6 I. W, U2 {9 R, m15 Imaging Science in Medicine, III: Digital (21st Century) X-Ray Imaging 264
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16 Intention-to-Treat Analysis 313

17 Interim Analyses 323
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18 Interrater Reliability 334
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3 D7 H: K- W1 ?19 Intrarater Reliability 340

20 Kaplan-Meier Plot 357
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6 p; R1 Z! L& R% o21 Logistic Regression 365
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22 Metadata 380

23 Microarray 392
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24 Multi-Armed Bandits, Gittins Index, and Its Calculation 416

25 Multiple Comparisons 436
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/ a: H; g5 i$ ~- d# \  L- z0 M26 Multiple Evaluators 446

27 Noncompartmental Analysis 457
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28 Nonparametric ROC Analysis for Diagnostic Trials 483
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! u  r; L5 Z- T& h+ ^' y: Y, f% d29 Optimal Biological Dose for Molecularly Targeted Therapies 496

) L% V0 e- W/ i0 S( D7 w( z30 Over- and Underdispersion Models 506

- n& C' w6 w8 {: R31 Permutation Tests in Clinical Trials 527

" g/ T/ U* @, Y! S1 Q! y32 Pharmacoepidemiology, Overview 536

33 Population Pharmacokinetic and Pharmacodynamic Methods 551
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34 Proportions: Inferences and Comparisons 570

35 Publication Bias 595

36 Quality of Life 608
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$ Z- O* Y9 @) K1 t2 o7 y/ q2 u37 Relative Risk Modeing 622
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. Z' Q3 M7 |2 G' S" h38 Sample Size Considerations for Morbidity/Mortality Trials 633
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39 Sample Size for Comparing Means 642
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+ E9 H9 j4 U* C* `, M& X: X/ C5 \40 Sample Size for Comparing Proportions 653

41 Sample Size for Comparing Time-to-Event Data 664
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42 Sample Size for Comparing Variabilities 672
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43 Screening, Models of 689

44 Screening Trials 721
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45 Secondary Efficacy End Points 731
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$ Y" O  Q, \7 ?# n46 Sensitivity, Specificity, and Receiver Operator Characteristic (ROC) Methods 740

6 D1 u3 x9 M# [) r3 \47 Software for Genetics/Genomics 752
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& k: Q" y5 v; H8 n6 j3 n0 }5 h/ o48 Stability Study Designs 778

6 t6 }( n2 Y% Y; \49 Subgroup Analysis 793

5 S6 w0 z/ A& m! s) w* _% }50 Survival Analysis, Overview 802
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51 The FDA and Regulatory Issues 815
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3 F8 Z; H, ]. }6 r! p2 l: a0 R52 The Kappa Index 836
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53 Treatment Interruption 846
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54 Trial Reports: Improving Reporting, Minimizing Bias, and Producing Better Evidence-Based Practice 860
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55 U.S. Department of Veterans Affairs Cooperative Studies Program 876

9 r# c. g4 U, }9 j$ y5 ^' ^' p56 Women's Health Initiative: Statistical Aspects and Selected Early Results 901
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57 World Health Organization (WHO): Global Health Situation 914
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; n# [+ M8 J0 a. N7 i3 MIndex 925
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$ r  b7 U1 J$ u/ C* mAuthor Information

N. BALAKRISHNAN, PHD, is Professor in the Department of Mathematics and Statistics at McMaster University, Canada. He is the author of over twenty books and is the coeditor of Encyclopedia of Statistical Sciences, Second Edition, also published by Wiley.



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Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods




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+ B/ c5 ~( L- S# Z  }' HMethods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs
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+ l, s( h( A. Q~~COMMING SOON~~
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