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

2 m4 ?7 c' b. v, cTitle: Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods
1 M6 y( X: I! \0 VAuthor(s): N. Balakrishnan
Publisher: Wiley
2 w, U1 j1 H' O0 t! IYear: 2014       
7 O7 |  R% p! [/ [3 E/ xEdition: 1
Language: English
6 ]" h, V7 E9 k0 U7 p8 r, BPages: 960
) K$ S6 d( ?" h/ d  h1 j7 KISBN: 1118304764, 9781118304761
Size: 63 MB (65940955 bytes)       
1 e& Y# E0 G9 u! _1 z, \5 KExtension: pdf
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Description

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:

• 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
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• Up-to-date research on the Cox proportional hazard model, frailty models, trial reports, intrarater reliability, conditional power, and the kappa index

. O3 R' _5 k5 L( E$ ?$ C: ~/ w9 M; R• 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

! Z) O% ]* u7 ~" y# p1 L$ iContributors xix

Preface xxiii

1 Analysis of Over- and Underdispersed Data 1
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. |9 ]* ?4 |* |4 G( H2 Analysis of Variance (ANOVA) 10
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3 Assessment of Health-Related Quality of Life 26

4 Bandit Processes and Response-Adaptive Clinical Trials: The Art of Exploration Versus Exploitation 40

9 ?7 c! t+ s0 U( u) P, Y5 Bayesian Dose-Finding Designs in Healthy Volunteers 51

6 Bootstrap 62
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& t+ e, B8 ?( M/ C: R4 M8 U" T$ T7 Conditional Power in Clinical Trial Monitoring 102
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/ k. h% \3 N! K  j- Z$ j+ N6 S8 Cost-Effectiveness Analysis 111

+ u2 b2 ?6 a3 l3 o2 Q9 Cox-Type Proportional Hazards Models 126

10 Empirical Likelihood Methods in Clinical Experiments 146

11 Frailty Models 166
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" _) n" Y7 s5 j8 a3 ]4 V7 {' ^12 Futility Analysis 174
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7 H$ H! U7 a1 m4 v13 Imaging Science in Medicine I: Overview 187

14 Imaging Science in Medicine, II: Basics of X-Ray Imaging 213

15 Imaging Science in Medicine, III: Digital (21st Century) X-Ray Imaging 264
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16 Intention-to-Treat Analysis 313

1 [( X& |4 g$ U7 U% K, c17 Interim Analyses 323

18 Interrater Reliability 334

2 e4 E9 M( W! H19 Intrarater Reliability 340
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20 Kaplan-Meier Plot 357
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21 Logistic Regression 365

" U# k4 ^2 N* E3 a/ r22 Metadata 380
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8 R. {. u  D9 C23 Microarray 392
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24 Multi-Armed Bandits, Gittins Index, and Its Calculation 416

  e6 V# Y) a! V" @7 A  q! f25 Multiple Comparisons 436

26 Multiple Evaluators 446

27 Noncompartmental Analysis 457
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28 Nonparametric ROC Analysis for Diagnostic Trials 483
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29 Optimal Biological Dose for Molecularly Targeted Therapies 496

0 f3 A: s7 ^& X/ {' A/ a+ w30 Over- and Underdispersion Models 506

3 Z. O2 |) @8 ]) N, f/ _" l31 Permutation Tests in Clinical Trials 527
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( E) F$ q3 X5 K5 R" E! x2 Q' O) ^32 Pharmacoepidemiology, Overview 536
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1 L# z1 ?9 u0 F) N33 Population Pharmacokinetic and Pharmacodynamic Methods 551
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/ \8 k& H$ @: O. a; a34 Proportions: Inferences and Comparisons 570

* v& g6 H- t) B( i  U5 \% ^35 Publication Bias 595

& g. d. |4 L$ x/ `8 ^1 Q36 Quality of Life 608
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37 Relative Risk Modeing 622

38 Sample Size Considerations for Morbidity/Mortality Trials 633
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" x3 y0 u: i* u$ o39 Sample Size for Comparing Means 642
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40 Sample Size for Comparing Proportions 653
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- R2 k/ w  T% W. |41 Sample Size for Comparing Time-to-Event Data 664

. K1 g9 w. G% t1 d42 Sample Size for Comparing Variabilities 672

' A2 i# L! L2 i$ N5 b43 Screening, Models of 689

; W+ @) W0 M( R) H7 s7 G1 q9 ^44 Screening Trials 721

$ X# n8 k6 I) s7 H. b2 R" `45 Secondary Efficacy End Points 731

46 Sensitivity, Specificity, and Receiver Operator Characteristic (ROC) Methods 740

( Z0 y- m) l; ~7 |4 o, i9 P' @47 Software for Genetics/Genomics 752

$ |  _8 Y& F& t6 Y3 D' l, k# ^48 Stability Study Designs 778
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49 Subgroup Analysis 793

( G( N7 B. D0 m. u) A. P$ ^2 v50 Survival Analysis, Overview 802

51 The FDA and Regulatory Issues 815
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* Z9 b# Z8 |7 T8 [/ {; m/ {, r52 The Kappa Index 836

( z: N) Y0 E  D9 H3 c0 n* ?53 Treatment Interruption 846

54 Trial Reports: Improving Reporting, Minimizing Bias, and Producing Better Evidence-Based Practice 860
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1 F0 e5 F# x3 ~4 p; d0 l55 U.S. Department of Veterans Affairs Cooperative Studies Program 876
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56 Women's Health Initiative: Statistical Aspects and Selected Early Results 901

& t: a7 J  Y0 v* a57 World Health Organization (WHO): Global Health Situation 914
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Index 925
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Author Information
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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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