Analyzing longitudinal clinical trial data : a practical guide / / by Craig Mallinckrodt and Ilya Lipkovich |
Autore | Mallinckrodt Craig H. <1958, > |
Pubbl/distr/stampa | Boca Raton, FL : , : Chapman and Hall/CRC, an imprint of Taylor and Francis, , 2016 |
Descrizione fisica | 1 online resource (330 pages) : illustrations, tables |
Disciplina | 615.5072/4 |
Collana | Chapman & Hall/CRC Biostatistics Series |
Soggetto topico | Clinical trials |
ISBN |
1-351-73768-6
1-315-18663-2 1-351-73769-4 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Cover -- Half Title -- Title Page -- Copyright Page -- Table of Contents -- Preface -- Acknowledgments -- List of Tables -- List of Figures -- List of Code Fragments -- Section I: Background and Setting -- 1: Introduction -- 2: Objectives and Estimands�Determining What to Estimate -- 3: Study Design�Collecting the Intended Data -- 4: Example Data -- 5: Mixed-Effects Models Review -- Section II: Modeling the Observed Data -- 6: Choice of Dependent Variable and Statistical Test -- 7: Modeling Covariance (Correlation) -- 8: Modeling Means Over Time -- 9: Accounting for Covariates -- 10: Categorical Data -- 11: Model Checking and Verification -- Section III: Methods for Dealing with Missing Data -- 12: Overview of Missing Data -- 13: Simple and Ad Hoc Approaches for Dealing with Missing Data -- 14: Direct Maximum Likelihood -- 15: Multiple Imputation -- 16: Inverse Probability Weighted Generalized Estimated Equations -- 17: Doubly Robust Methods -- 18: MNAR Methods -- 19: Methods for Incomplete Categorical Data -- Section IV: A Comprehensive Approach to Study Development and Analyses -- 20: Developing Statistical Analysis Plans -- 21: Example Analyses of Clinical Trial Data -- References -- Index. |
Record Nr. | UNINA-9910155108403321 |
Mallinckrodt Craig H. <1958, >
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Boca Raton, FL : , : Chapman and Hall/CRC, an imprint of Taylor and Francis, , 2016 | ||
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Lo trovi qui: Univ. Federico II | ||
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Bayesian adaptive methods for clinical trials / / Scott M. Berry. [et al.] |
Pubbl/distr/stampa | Boca Raton : , : Chapman & Hall/CRC, , 2011 |
Descrizione fisica | 1 online resource (316 p.) |
Disciplina | 615.5072/4 |
Altri autori (Persone) | BerryScott M |
Collana | Chapman & Hall/CRC biostatistics series |
Soggetto topico |
Clinical trials - Statistical methods
Bayesian statistical decision theory |
Soggetto genere / forma | Electronic books. |
ISBN |
0-429-15242-6
1-282-90299-7 9786612902994 1-4398-2551-3 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Front cover; Contents; Foreword; Preface; CHAPTER 1: Statistical approaches for clinical trials; CHAPTER 2: Basics of Bayesian inference; CHAPTER 3: Phase I studies; CHAPTER 4: Phase II studies; CHAPTER 5: Phase III studies; CHAPTER 6: Special topics; References; Back cover |
Record Nr. | UNINA-9910458802003321 |
Boca Raton : , : Chapman & Hall/CRC, , 2011 | ||
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Lo trovi qui: Univ. Federico II | ||
|
Bayesian adaptive methods for clinical trials / / Scott M. Berry. [et al.] |
Pubbl/distr/stampa | Boca Raton : , : Chapman & Hall/CRC, , 2011 |
Descrizione fisica | 1 online resource (316 p.) |
Disciplina | 615.5072/4 |
Altri autori (Persone) | BerryScott M |
Collana | Chapman & Hall/CRC biostatistics series |
Soggetto topico |
Clinical trials - Statistical methods
Bayesian statistical decision theory |
ISBN |
0-429-15242-6
1-282-90299-7 9786612902994 1-4398-2551-3 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Front cover; Contents; Foreword; Preface; CHAPTER 1: Statistical approaches for clinical trials; CHAPTER 2: Basics of Bayesian inference; CHAPTER 3: Phase I studies; CHAPTER 4: Phase II studies; CHAPTER 5: Phase III studies; CHAPTER 6: Special topics; References; Back cover |
Record Nr. | UNINA-9910785358203321 |
Boca Raton : , : Chapman & Hall/CRC, , 2011 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
Bayesian adaptive methods for clinical trials / / Scott M. Berry. [et al.] |
Pubbl/distr/stampa | Boca Raton : , : Chapman & Hall/CRC, , 2011 |
Descrizione fisica | 1 online resource (316 p.) |
Disciplina | 615.5072/4 |
Altri autori (Persone) | BerryScott M |
Collana | Chapman & Hall/CRC biostatistics series |
Soggetto topico |
Clinical trials - Statistical methods
Bayesian statistical decision theory |
ISBN |
0-429-15242-6
1-282-90299-7 9786612902994 1-4398-2551-3 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Front cover; Contents; Foreword; Preface; CHAPTER 1: Statistical approaches for clinical trials; CHAPTER 2: Basics of Bayesian inference; CHAPTER 3: Phase I studies; CHAPTER 4: Phase II studies; CHAPTER 5: Phase III studies; CHAPTER 6: Special topics; References; Back cover |
Record Nr. | UNINA-9910808949303321 |
Boca Raton : , : Chapman & Hall/CRC, , 2011 | ||
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Lo trovi qui: Univ. Federico II | ||
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Binary data analysis of randomized clinical trials with noncompliance [[electronic resource] /] / Kung-Jong Lui |
Autore | Lui Kung-Jong |
Pubbl/distr/stampa | Chichester, West Sussex, United Kingdom, : John Wiley & Sons Inc., 2011 |
Descrizione fisica | 1 online resource (332 p.) |
Disciplina | 615.5072/4 |
Collana | Statistics in practice |
Soggetto topico |
Clinical trials - Statistical methods
Drugs - Testing - Statistical methods |
ISBN |
1-283-40536-9
9786613405364 1-119-99160-9 1-119-99161-7 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Binary Data Analysis of Randomized Clinical Trials with Noncompliance; Contents; Preface; About the Author; 1 Randomized clinical trials with noncompliance: issues, definitions and problems of commonly used analyses; 1.1 Randomized encouragement design (RED); 1.2 Randomized consent designs; 1.2.1 Single-consent randomized design (SCRD); 1.2.2 Double-consent randomized design (DCRD); 1.3 Treatment efficacy versus programmatic effectiveness; 1.4 Definitions of commonly used terms and assumptions; 1.5 Most commonly used analyses for a RCT with noncompliance; Exercises
2 Randomized clinical trials with noncompliance under parallel groups design 2.1 Testing superiority; 2.2 Testing noninferiority; 2.2.1 Using the difference in proportions; 2.2.2 Using the ratio of proportions; 2.2.3 Using the odds ratio of proportions; 2.3 Testing equivalence; 2.3.1 Using the difference in proportions; 2.3.2 Using the ratio of proportions; 2.3.3 Using the odds ratio of proportions; 2.4 Interval estimation; 2.4.1 Estimation of the proportion difference; 2.4.2 Estimation of the proportion ratio; 2.4.3 Estimation of the odds ratio; 2.5 Sample size determination 2.5.1 Sample size calculation for testing superiority 2.5.2 Sample size calculation for testing noninferiority; 2.5.3 Sample size calculation for testing equivalence; 2.6 Risk model-based approach; 2.6.1 Constant risk additive model; 2.6.2 Constant risk multiplicative model; 2.6.3 Generalized risk additive model; 2.6.4 Generalized risk multiplicative model; Exercises; Appendix; 3 Randomized clinical trials with noncompliance in stratified sampling; 3.1 Testing superiority; 3.2 Testing noninferiority; 3.2.1 Using the difference in proportions; 3.2.2 Using the ratio of proportions 3.2.3 Using the odds ratio of proportions 3.3 Testing equivalence; 3.3.1 Using the difference in proportions; 3.3.2 Using the ratio of proportions; 3.3.3 Using the odds ratio of proportions; 3.4 Interval estimation; 3.4.1 Estimation of the proportion difference; 3.4.2 Estimation of the proportion ratio; 3.4.3 Estimation of the odds ratio; 3.5 Test homogeneity of index in large strata; 3.5.1 Testing homogeneity of the proportion difference; 3.5.2 Testing homogeneity of the proportion ratio; 3.5.3 Test homogeneity of the odds ratio; Exercises; Appendix 4 Randomized clinical trials with noncompliance under cluster sampling 4.1 Testing superiority; 4.2 Testing noninferiority; 4.2.1 Using the difference in proportions; 4.2.2 Using the ratio of proportions; 4.2.3 Using the odds ratio of proportions; 4.3 Testing equivalence; 4.3.1 Using the difference in proportions; 4.3.2 Using the ratio of proportions; 4.3.3 Using the odds ratio of proportions; 4.4 Interval estimation; 4.4.1 Estimation of the proportion difference; 4.4.2 Estimation of the proportion ratio; 4.4.3 Estimation of the odds ratio; 4.5 Sample size determination 4.5.1 Sample size calculation for testing superiority |
Record Nr. | UNINA-9910131022703321 |
Lui Kung-Jong
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Chichester, West Sussex, United Kingdom, : John Wiley & Sons Inc., 2011 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
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Binary data analysis of randomized clinical trials with noncompliance [[electronic resource] /] / Kung-Jong Lui |
Autore | Lui Kung-Jong |
Pubbl/distr/stampa | Chichester, West Sussex, United Kingdom, : John Wiley & Sons Inc., 2011 |
Descrizione fisica | 1 online resource (332 p.) |
Disciplina | 615.5072/4 |
Collana | Statistics in practice |
Soggetto topico |
Clinical trials - Statistical methods
Drugs - Testing - Statistical methods |
ISBN |
1-283-40536-9
9786613405364 1-119-99160-9 1-119-99161-7 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Binary Data Analysis of Randomized Clinical Trials with Noncompliance; Contents; Preface; About the Author; 1 Randomized clinical trials with noncompliance: issues, definitions and problems of commonly used analyses; 1.1 Randomized encouragement design (RED); 1.2 Randomized consent designs; 1.2.1 Single-consent randomized design (SCRD); 1.2.2 Double-consent randomized design (DCRD); 1.3 Treatment efficacy versus programmatic effectiveness; 1.4 Definitions of commonly used terms and assumptions; 1.5 Most commonly used analyses for a RCT with noncompliance; Exercises
2 Randomized clinical trials with noncompliance under parallel groups design 2.1 Testing superiority; 2.2 Testing noninferiority; 2.2.1 Using the difference in proportions; 2.2.2 Using the ratio of proportions; 2.2.3 Using the odds ratio of proportions; 2.3 Testing equivalence; 2.3.1 Using the difference in proportions; 2.3.2 Using the ratio of proportions; 2.3.3 Using the odds ratio of proportions; 2.4 Interval estimation; 2.4.1 Estimation of the proportion difference; 2.4.2 Estimation of the proportion ratio; 2.4.3 Estimation of the odds ratio; 2.5 Sample size determination 2.5.1 Sample size calculation for testing superiority 2.5.2 Sample size calculation for testing noninferiority; 2.5.3 Sample size calculation for testing equivalence; 2.6 Risk model-based approach; 2.6.1 Constant risk additive model; 2.6.2 Constant risk multiplicative model; 2.6.3 Generalized risk additive model; 2.6.4 Generalized risk multiplicative model; Exercises; Appendix; 3 Randomized clinical trials with noncompliance in stratified sampling; 3.1 Testing superiority; 3.2 Testing noninferiority; 3.2.1 Using the difference in proportions; 3.2.2 Using the ratio of proportions 3.2.3 Using the odds ratio of proportions 3.3 Testing equivalence; 3.3.1 Using the difference in proportions; 3.3.2 Using the ratio of proportions; 3.3.3 Using the odds ratio of proportions; 3.4 Interval estimation; 3.4.1 Estimation of the proportion difference; 3.4.2 Estimation of the proportion ratio; 3.4.3 Estimation of the odds ratio; 3.5 Test homogeneity of index in large strata; 3.5.1 Testing homogeneity of the proportion difference; 3.5.2 Testing homogeneity of the proportion ratio; 3.5.3 Test homogeneity of the odds ratio; Exercises; Appendix 4 Randomized clinical trials with noncompliance under cluster sampling 4.1 Testing superiority; 4.2 Testing noninferiority; 4.2.1 Using the difference in proportions; 4.2.2 Using the ratio of proportions; 4.2.3 Using the odds ratio of proportions; 4.3 Testing equivalence; 4.3.1 Using the difference in proportions; 4.3.2 Using the ratio of proportions; 4.3.3 Using the odds ratio of proportions; 4.4 Interval estimation; 4.4.1 Estimation of the proportion difference; 4.4.2 Estimation of the proportion ratio; 4.4.3 Estimation of the odds ratio; 4.5 Sample size determination 4.5.1 Sample size calculation for testing superiority |
Record Nr. | UNINA-9910813859003321 |
Lui Kung-Jong
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Chichester, West Sussex, United Kingdom, : John Wiley & Sons Inc., 2011 | ||
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Lo trovi qui: Univ. Federico II | ||
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Clinical trial methodology / / Karl E. Peace, Ding-Geng (Din) Chen |
Autore | Peace Karl E. <1941, > |
Pubbl/distr/stampa | Boca Raton : , : Chapman and Hall/CRC Press, , 2011 |
Descrizione fisica | 1 online resource (422 p.) |
Disciplina | 615.5072/4 |
Altri autori (Persone) | ChenDing-Geng |
Collana | Chapman & Hall/CRC biostatistics series |
Soggetto topico |
Clinical trials
Drugs - Testing |
Soggetto genere / forma | Electronic books. |
ISBN |
0-429-14207-2
1-58488-918-7 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Front cover; Contents; Preface; Chapter 1: Overview of Clinical Trial Methodology; Chapter 2: Overview of the Drug Development Processand Regulation of Clinical Trials; Chapter 3: Ethical Considerations in the Designand Conduct of Clinical Trials; Chapter 4: Sample Size Considerations in ClinicalTrials Pre-Market Approval; Chapter 5: Sequential, Group Sequential, StochasticCurtailment, and Adaptive DesignProcedures in Clinical Trials; Chapter 6: Biostatistical Aspects of the Protocol; Chapter 7: The Statistical Analysis Plan; Chapter 8: Pooling of Data from Multicenter Clinical Trials
Chapter 9: Validity of Statistical InferenceChapter 10: Bioequivalence Clinical Trials; Chapter 11: Dose and Frequency Determinationfrom Phase II Clinical Trials in StressTest-Induced Angina; Chapter 12: Confirmation of Clinically Optimal Dosingin the Treatment of Duodenal Ulcers:A Phase III Dose Comparison Trial; Chapter 13: Pivotal Proof-of-Efficacy Clinical Trialsin the Prevention of NANSAID-InducedGastric Ulceration; Chapter 14: Clinical Trials in the Treatmentof Alzheimer's Disease Based uponEnrichment Designs; Chapter 15: A Clinical Trial to Establish Reductionof CHD Risk Chapter 16: Pivotal Proof-of-Efficacy Clinical Trialsin the Treatment of Panic DisorderChapter 17: Combination Clinical Trials; Chapter 18: Monitoring Clinical Trials for Adverse Events; Index; Back cover |
Record Nr. | UNINA-9910458853903321 |
Peace Karl E. <1941, >
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Boca Raton : , : Chapman and Hall/CRC Press, , 2011 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
Clinical trial methodology / / Karl E. Peace, Ding-Geng (Din) Chen |
Autore | Peace Karl E. <1941, > |
Pubbl/distr/stampa | Boca Raton : , : Chapman and Hall/CRC Press, , 2011 |
Descrizione fisica | 1 online resource (422 p.) |
Disciplina | 615.5072/4 |
Altri autori (Persone) | ChenDing-Geng |
Collana | Chapman & Hall/CRC biostatistics series |
Soggetto topico |
Clinical trials
Drugs - Testing |
ISBN |
0-429-14207-2
1-58488-918-7 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Front cover; Contents; Preface; Chapter 1: Overview of Clinical Trial Methodology; Chapter 2: Overview of the Drug Development Processand Regulation of Clinical Trials; Chapter 3: Ethical Considerations in the Designand Conduct of Clinical Trials; Chapter 4: Sample Size Considerations in ClinicalTrials Pre-Market Approval; Chapter 5: Sequential, Group Sequential, StochasticCurtailment, and Adaptive DesignProcedures in Clinical Trials; Chapter 6: Biostatistical Aspects of the Protocol; Chapter 7: The Statistical Analysis Plan; Chapter 8: Pooling of Data from Multicenter Clinical Trials
Chapter 9: Validity of Statistical InferenceChapter 10: Bioequivalence Clinical Trials; Chapter 11: Dose and Frequency Determinationfrom Phase II Clinical Trials in StressTest-Induced Angina; Chapter 12: Confirmation of Clinically Optimal Dosingin the Treatment of Duodenal Ulcers:A Phase III Dose Comparison Trial; Chapter 13: Pivotal Proof-of-Efficacy Clinical Trialsin the Prevention of NANSAID-InducedGastric Ulceration; Chapter 14: Clinical Trials in the Treatmentof Alzheimer's Disease Based uponEnrichment Designs; Chapter 15: A Clinical Trial to Establish Reductionof CHD Risk Chapter 16: Pivotal Proof-of-Efficacy Clinical Trialsin the Treatment of Panic DisorderChapter 17: Combination Clinical Trials; Chapter 18: Monitoring Clinical Trials for Adverse Events; Index; Back cover |
Record Nr. | UNINA-9910785026803321 |
Peace Karl E. <1941, >
![]() |
||
Boca Raton : , : Chapman and Hall/CRC Press, , 2011 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
Clinical trial methodology / / Karl E. Peace, Ding-Geng (Din) Chen |
Autore | Peace Karl E. <1941, > |
Pubbl/distr/stampa | Boca Raton : , : Chapman and Hall/CRC Press, , 2011 |
Descrizione fisica | 1 online resource (422 p.) |
Disciplina | 615.5072/4 |
Altri autori (Persone) | ChenDing-Geng |
Collana | Chapman & Hall/CRC biostatistics series |
Soggetto topico |
Clinical trials
Drugs - Testing |
ISBN |
0-429-14207-2
1-58488-918-7 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Front cover; Contents; Preface; Chapter 1: Overview of Clinical Trial Methodology; Chapter 2: Overview of the Drug Development Processand Regulation of Clinical Trials; Chapter 3: Ethical Considerations in the Designand Conduct of Clinical Trials; Chapter 4: Sample Size Considerations in ClinicalTrials Pre-Market Approval; Chapter 5: Sequential, Group Sequential, StochasticCurtailment, and Adaptive DesignProcedures in Clinical Trials; Chapter 6: Biostatistical Aspects of the Protocol; Chapter 7: The Statistical Analysis Plan; Chapter 8: Pooling of Data from Multicenter Clinical Trials
Chapter 9: Validity of Statistical InferenceChapter 10: Bioequivalence Clinical Trials; Chapter 11: Dose and Frequency Determinationfrom Phase II Clinical Trials in StressTest-Induced Angina; Chapter 12: Confirmation of Clinically Optimal Dosingin the Treatment of Duodenal Ulcers:A Phase III Dose Comparison Trial; Chapter 13: Pivotal Proof-of-Efficacy Clinical Trialsin the Prevention of NANSAID-InducedGastric Ulceration; Chapter 14: Clinical Trials in the Treatmentof Alzheimer's Disease Based uponEnrichment Designs; Chapter 15: A Clinical Trial to Establish Reductionof CHD Risk Chapter 16: Pivotal Proof-of-Efficacy Clinical Trialsin the Treatment of Panic DisorderChapter 17: Combination Clinical Trials; Chapter 18: Monitoring Clinical Trials for Adverse Events; Index; Back cover |
Record Nr. | UNINA-9910799965803321 |
Peace Karl E. <1941, >
![]() |
||
Boca Raton : , : Chapman and Hall/CRC Press, , 2011 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
Clinical trial methodology / / Karl E. Peace, Ding-Geng (Din) Chen |
Autore | Peace Karl E. <1941, > |
Edizione | [1st ed.] |
Pubbl/distr/stampa | Boca Raton : , : Chapman and Hall/CRC Press, , 2011 |
Descrizione fisica | 1 online resource (422 p.) |
Disciplina |
615.5072/4
615.50724 |
Altri autori (Persone) | ChenDing-Geng |
Collana | Chapman & Hall/CRC biostatistics series |
Soggetto topico |
Clinical trials
Drugs - Testing |
ISBN |
0-429-14207-2
1-58488-918-7 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Front cover; Contents; Preface; Chapter 1: Overview of Clinical Trial Methodology; Chapter 2: Overview of the Drug Development Processand Regulation of Clinical Trials; Chapter 3: Ethical Considerations in the Designand Conduct of Clinical Trials; Chapter 4: Sample Size Considerations in ClinicalTrials Pre-Market Approval; Chapter 5: Sequential, Group Sequential, StochasticCurtailment, and Adaptive DesignProcedures in Clinical Trials; Chapter 6: Biostatistical Aspects of the Protocol; Chapter 7: The Statistical Analysis Plan; Chapter 8: Pooling of Data from Multicenter Clinical Trials
Chapter 9: Validity of Statistical InferenceChapter 10: Bioequivalence Clinical Trials; Chapter 11: Dose and Frequency Determinationfrom Phase II Clinical Trials in StressTest-Induced Angina; Chapter 12: Confirmation of Clinically Optimal Dosingin the Treatment of Duodenal Ulcers:A Phase III Dose Comparison Trial; Chapter 13: Pivotal Proof-of-Efficacy Clinical Trialsin the Prevention of NANSAID-InducedGastric Ulceration; Chapter 14: Clinical Trials in the Treatmentof Alzheimer's Disease Based uponEnrichment Designs; Chapter 15: A Clinical Trial to Establish Reductionof CHD Risk Chapter 16: Pivotal Proof-of-Efficacy Clinical Trialsin the Treatment of Panic DisorderChapter 17: Combination Clinical Trials; Chapter 18: Monitoring Clinical Trials for Adverse Events; Index; Back cover |
Record Nr. | UNINA-9910817366103321 |
Peace Karl E. <1941, >
![]() |
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Boca Raton : , : Chapman and Hall/CRC Press, , 2011 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|