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Cross-over trials in clinical research [[electronic resource] /] / Stephen Senn
Cross-over trials in clinical research [[electronic resource] /] / Stephen Senn
Autore Senn Stephen
Edizione [2nd ed.]
Pubbl/distr/stampa Chichester ; ; Hoboken, NJ, : J. Wiley, c2002
Descrizione fisica 1 online resource (363 p.)
Disciplina 615.19
615.5/07/2
Collana Statistics in practice
Soggetto topico Crossover trials
Clinical trials
Soggetto genere / forma Electronic books.
ISBN 1-280-27006-3
9786610270064
0-470-35829-7
0-470-85458-8
0-470-85459-6
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Cross-over Trials in Clinical Research; Contents; Preface to the second edition; Preface to the first edition; 1 Introduction; 1.1 The purpose of this chapter; 1.2 An example; 1.3 Why are cross-over trials performed?; 1.4 What are the disadvantages of cross-over trials?; 1.5 Where are cross-over trials useful?; 1.6 What attitude to cross-over trials will be adopted in this book?; 1.7 Carry-over; 1.8 What may be done about carry-over?; 1.9 Other attitudes to be adopted; 1.10 Where else can one find out about cross-over trials?
2 Some basic considerations concerning estimation in clinical trials*2.1 The purpose of this chapter; 2.2 Assumed background knowledge; 2.3 Control in clinical trials; 2.4 Two purposes of estimation; 2.5 Some features of estimation; 2.6 Practical consequences for cross-over trials; 3 The AB/BA design with Normal data; 3.1 An example; 3.2 A simple analysis ignoring the effect of period; 3.3 Student's approach*; 3.4 Assumptions in the matched-pairs t approach; 3.5 Adjusting for a period effect: two-sample t approach; 3.6 Adjusting for a period effect: the Hills-Armitage approach
3.7 Examining period effects3.8 Testing for carry-over and/or treatment by period interaction*; 3.9 A model for the AB/BA cross-over*; 3.10 Carry-over or treatment by period interaction?*; 3.11 Confidence intervals for carry-over*; 3.12 Are unbiased estimators of the treatment effect available?*; 3.13 Can we adjust for carry-over?*; 3.14 The two-stage analysis*; 3.15 Correcting the two-stage procedure*; 3.16 Use of baseline measurements; 3.17 A Bayesian approach; 3.18 Computer analysis; 3.19 Further reading; 3.20 Recommendations; Appendix 3.1 Analysis with GenStat®
Appendix 3.2 Analysis with S-Plus®4 Other outcomes and the AB/BA design; 4.1 Introduction; 4.2 Transformations; 4.3 Non-parametric methods; 4.4 Binary outcomes; 4.5 Ordered categorical data; 4.6 Frequency data; 4.7 'Survival' data*; 4.8 Final remarks; Appendix 4.1 Analysis with GenStat®; Appendix 4.2 Analysis with S-Plus®; 5 Normal data from designs with three or more treatments; 5.1 Why do we have designs with three or more treatments?; 5.2 Sequences for trials with three or more treatments; 5.3 Analyses ignoring the effect of period; 5.4 Allowing for period effects
5.5 Other miscellaneous issues5.6 Recommendations; Appendix 5.1 Analysis with GenStat®; Appendix 5.2 Analysis with S-Plus®; 6 Other outcomes from designs with three or more treatments; 6.1 Introduction; 6.2 Analyses which take no account of period effects; 6.3 Non-parametric analyses adjusting for period effects; 6.4 Hodges-Lehmann type estimators*; 6.5 A stratified period adjusted sign test; 6.6 Binary data; 6.7 Other analyses; Appendix 6.1 Analysis with GenStat®; Appendix 6.2 Analysis with S-Plus®; 7 Some special designs; 7.1 The scope of this chapter; 7.2 Factorial designs
7.3 Incomplete block designs
Record Nr. UNINA-9910143510703321
Senn Stephen  
Chichester ; ; Hoboken, NJ, : J. Wiley, c2002
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Cross-over trials in clinical research [[electronic resource] /] / Stephen Senn
Cross-over trials in clinical research [[electronic resource] /] / Stephen Senn
Autore Senn Stephen
Edizione [2nd ed.]
Pubbl/distr/stampa Chichester ; ; Hoboken, NJ, : J. Wiley, c2002
Descrizione fisica 1 online resource (363 p.)
Disciplina 615.19
615.5/07/2
Collana Statistics in practice
Soggetto topico Crossover trials
Clinical trials
ISBN 1-280-27006-3
9786610270064
0-470-35829-7
0-470-85458-8
0-470-85459-6
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Cross-over Trials in Clinical Research; Contents; Preface to the second edition; Preface to the first edition; 1 Introduction; 1.1 The purpose of this chapter; 1.2 An example; 1.3 Why are cross-over trials performed?; 1.4 What are the disadvantages of cross-over trials?; 1.5 Where are cross-over trials useful?; 1.6 What attitude to cross-over trials will be adopted in this book?; 1.7 Carry-over; 1.8 What may be done about carry-over?; 1.9 Other attitudes to be adopted; 1.10 Where else can one find out about cross-over trials?
2 Some basic considerations concerning estimation in clinical trials*2.1 The purpose of this chapter; 2.2 Assumed background knowledge; 2.3 Control in clinical trials; 2.4 Two purposes of estimation; 2.5 Some features of estimation; 2.6 Practical consequences for cross-over trials; 3 The AB/BA design with Normal data; 3.1 An example; 3.2 A simple analysis ignoring the effect of period; 3.3 Student's approach*; 3.4 Assumptions in the matched-pairs t approach; 3.5 Adjusting for a period effect: two-sample t approach; 3.6 Adjusting for a period effect: the Hills-Armitage approach
3.7 Examining period effects3.8 Testing for carry-over and/or treatment by period interaction*; 3.9 A model for the AB/BA cross-over*; 3.10 Carry-over or treatment by period interaction?*; 3.11 Confidence intervals for carry-over*; 3.12 Are unbiased estimators of the treatment effect available?*; 3.13 Can we adjust for carry-over?*; 3.14 The two-stage analysis*; 3.15 Correcting the two-stage procedure*; 3.16 Use of baseline measurements; 3.17 A Bayesian approach; 3.18 Computer analysis; 3.19 Further reading; 3.20 Recommendations; Appendix 3.1 Analysis with GenStat®
Appendix 3.2 Analysis with S-Plus®4 Other outcomes and the AB/BA design; 4.1 Introduction; 4.2 Transformations; 4.3 Non-parametric methods; 4.4 Binary outcomes; 4.5 Ordered categorical data; 4.6 Frequency data; 4.7 'Survival' data*; 4.8 Final remarks; Appendix 4.1 Analysis with GenStat®; Appendix 4.2 Analysis with S-Plus®; 5 Normal data from designs with three or more treatments; 5.1 Why do we have designs with three or more treatments?; 5.2 Sequences for trials with three or more treatments; 5.3 Analyses ignoring the effect of period; 5.4 Allowing for period effects
5.5 Other miscellaneous issues5.6 Recommendations; Appendix 5.1 Analysis with GenStat®; Appendix 5.2 Analysis with S-Plus®; 6 Other outcomes from designs with three or more treatments; 6.1 Introduction; 6.2 Analyses which take no account of period effects; 6.3 Non-parametric analyses adjusting for period effects; 6.4 Hodges-Lehmann type estimators*; 6.5 A stratified period adjusted sign test; 6.6 Binary data; 6.7 Other analyses; Appendix 6.1 Analysis with GenStat®; Appendix 6.2 Analysis with S-Plus®; 7 Some special designs; 7.1 The scope of this chapter; 7.2 Factorial designs
7.3 Incomplete block designs
Record Nr. UNINA-9910830408003321
Senn Stephen  
Chichester ; ; Hoboken, NJ, : J. Wiley, c2002
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Cross-over trials in clinical research [[electronic resource] /] / Stephen Senn
Cross-over trials in clinical research [[electronic resource] /] / Stephen Senn
Autore Senn Stephen
Edizione [2nd ed.]
Pubbl/distr/stampa Chichester ; ; Hoboken, NJ, : J. Wiley, c2002
Descrizione fisica 1 online resource (363 p.)
Disciplina 615.19
615.5/07/2
Collana Statistics in practice
Soggetto topico Crossover trials
Clinical trials
ISBN 1-280-27006-3
9786610270064
0-470-35829-7
0-470-85458-8
0-470-85459-6
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Cross-over Trials in Clinical Research; Contents; Preface to the second edition; Preface to the first edition; 1 Introduction; 1.1 The purpose of this chapter; 1.2 An example; 1.3 Why are cross-over trials performed?; 1.4 What are the disadvantages of cross-over trials?; 1.5 Where are cross-over trials useful?; 1.6 What attitude to cross-over trials will be adopted in this book?; 1.7 Carry-over; 1.8 What may be done about carry-over?; 1.9 Other attitudes to be adopted; 1.10 Where else can one find out about cross-over trials?
2 Some basic considerations concerning estimation in clinical trials*2.1 The purpose of this chapter; 2.2 Assumed background knowledge; 2.3 Control in clinical trials; 2.4 Two purposes of estimation; 2.5 Some features of estimation; 2.6 Practical consequences for cross-over trials; 3 The AB/BA design with Normal data; 3.1 An example; 3.2 A simple analysis ignoring the effect of period; 3.3 Student's approach*; 3.4 Assumptions in the matched-pairs t approach; 3.5 Adjusting for a period effect: two-sample t approach; 3.6 Adjusting for a period effect: the Hills-Armitage approach
3.7 Examining period effects3.8 Testing for carry-over and/or treatment by period interaction*; 3.9 A model for the AB/BA cross-over*; 3.10 Carry-over or treatment by period interaction?*; 3.11 Confidence intervals for carry-over*; 3.12 Are unbiased estimators of the treatment effect available?*; 3.13 Can we adjust for carry-over?*; 3.14 The two-stage analysis*; 3.15 Correcting the two-stage procedure*; 3.16 Use of baseline measurements; 3.17 A Bayesian approach; 3.18 Computer analysis; 3.19 Further reading; 3.20 Recommendations; Appendix 3.1 Analysis with GenStat®
Appendix 3.2 Analysis with S-Plus®4 Other outcomes and the AB/BA design; 4.1 Introduction; 4.2 Transformations; 4.3 Non-parametric methods; 4.4 Binary outcomes; 4.5 Ordered categorical data; 4.6 Frequency data; 4.7 'Survival' data*; 4.8 Final remarks; Appendix 4.1 Analysis with GenStat®; Appendix 4.2 Analysis with S-Plus®; 5 Normal data from designs with three or more treatments; 5.1 Why do we have designs with three or more treatments?; 5.2 Sequences for trials with three or more treatments; 5.3 Analyses ignoring the effect of period; 5.4 Allowing for period effects
5.5 Other miscellaneous issues5.6 Recommendations; Appendix 5.1 Analysis with GenStat®; Appendix 5.2 Analysis with S-Plus®; 6 Other outcomes from designs with three or more treatments; 6.1 Introduction; 6.2 Analyses which take no account of period effects; 6.3 Non-parametric analyses adjusting for period effects; 6.4 Hodges-Lehmann type estimators*; 6.5 A stratified period adjusted sign test; 6.6 Binary data; 6.7 Other analyses; Appendix 6.1 Analysis with GenStat®; Appendix 6.2 Analysis with S-Plus®; 7 Some special designs; 7.1 The scope of this chapter; 7.2 Factorial designs
7.3 Incomplete block designs
Record Nr. UNINA-9910840829603321
Senn Stephen  
Chichester ; ; Hoboken, NJ, : J. Wiley, c2002
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Statistical issues in drug development / / Stephen Senn
Statistical issues in drug development / / Stephen Senn
Autore Senn Stephen
Edizione [Third edition.]
Pubbl/distr/stampa Hoboken, New Jersey ; ; West, Sussex, England : , : Wiley Blackwell, , [2021]
Descrizione fisica 1 online resource (643 pages)
Disciplina 615.19
Collana Statistics in practice
Soggetto topico Drug development - Statistical methods
Soggetto genere / forma Electronic books.
ISBN 1-119-23859-5
1-119-23860-9
1-119-23861-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Record Nr. UNINA-9910555274803321
Senn Stephen  
Hoboken, New Jersey ; ; West, Sussex, England : , : Wiley Blackwell, , [2021]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Statistical issues in drug development / / Stephen Senn
Statistical issues in drug development / / Stephen Senn
Autore Senn Stephen
Edizione [Third edition.]
Pubbl/distr/stampa Hoboken, New Jersey ; ; West, Sussex, England : , : Wiley Blackwell, , [2021]
Descrizione fisica 1 online resource (643 pages)
Disciplina 615.19
Collana Statistics in practice
Soggetto topico Drug development - Statistical methods
ISBN 1-119-23859-5
1-119-23860-9
1-119-23861-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto A Brief and Superficial History of Statistics for Drug Developers -- Design and Interpretation of Clinical Trials as Seen by a Statistician -- Probability, Bayes, P-values, Tests of Hypotheses and Confidence Intervals -- The Work of the Pharmaceutical Statistician -- Allocating Treatments to Patients in Clinical Trials -- Baselines and Covariate Information -- The Measurement of Treatment Effects -- Demographic Subgroups : Representation and Analysis -- Multiplicity -- Intention to Treat, Missing Data and Related Matters -- One-sided and Two-sided Tests and other Issues to Do with Significance and P-values -- Determining the Sample Size -- Multicentre Trials -- Active Control Equivalence Studies -- Meta-Analysis -- Cross-over Trials -- n-of-1 Trials -- Sequential Trial -- Dose-finding -- Concerning Pharmacokinetics and Pharmacodynamics -- Bioequivalence Studies -- Safety Data, Harms, Drug Monitoring and Pharmaco-epidemiology -- Pharmaco-economics and Portfolio Management -- Concerning Pharmacogenetics, Pharmacogenomics and Related Matters.
Record Nr. UNINA-9910830834503321
Senn Stephen  
Hoboken, New Jersey ; ; West, Sussex, England : , : Wiley Blackwell, , [2021]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Statistical issues in drug development / / Stephen Senn
Statistical issues in drug development / / Stephen Senn
Autore Senn Stephen
Edizione [2nd edition.]
Pubbl/distr/stampa Chichester, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007
Descrizione fisica 1 online resource (522 p.)
Disciplina 615/.190727
Collana Statistics in practice
Soggetto topico Drug development - Statistical methods
ISBN 1-281-30834-X
9786611308346
0-470-72358-0
0-470-72357-2
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto A brief and superficial history of statistics for drug developers -- Design and interpretation of clinical trials as seen by a statistician -- Probability, Bayes, P-values, tests of hypotheses, and confidence intervals -- The work of the pharmaceutical statistician -- Allocating treatments to patients in clinical trials -- Baselines and covariate information --
The measurement of treatment effects -- Demographic subgroups : representation and analysis -- Multiplicity -- Intention to treat, missing data and related matters -- One-sided and two-sided tests and other issues to do with significance and P-values -- Determining the sample size -- Multicentre trials -- Active control equivalence studies --
Meta-analysis -- Cross-over trials -- n-of-1 trials -- Sequential trials -- Dose-finding -- Concerning pharmacokinetics and pharmacodynamics -- Bioequivalence studies -- Safety data, harms, drug monitoring, and pharmaco-epidemiology -- Pharmaco-economics and portfolio management -- Concerning pharmacogenetics, pharmacogenomics, and related matters.
Record Nr. UNINA-9910784775903321
Senn Stephen  
Chichester, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Statistical issues in drug development / / Stephen Senn
Statistical issues in drug development / / Stephen Senn
Autore Senn Stephen
Edizione [2nd edition.]
Pubbl/distr/stampa Chichester, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007
Descrizione fisica 1 online resource (522 p.)
Disciplina 615/.190727
Collana Statistics in practice
Soggetto topico Drug development - Statistical methods
ISBN 1-281-30834-X
9786611308346
0-470-72358-0
0-470-72357-2
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto A brief and superficial history of statistics for drug developers -- Design and interpretation of clinical trials as seen by a statistician -- Probability, Bayes, P-values, tests of hypotheses, and confidence intervals -- The work of the pharmaceutical statistician -- Allocating treatments to patients in clinical trials -- Baselines and covariate information --
The measurement of treatment effects -- Demographic subgroups : representation and analysis -- Multiplicity -- Intention to treat, missing data and related matters -- One-sided and two-sided tests and other issues to do with significance and P-values -- Determining the sample size -- Multicentre trials -- Active control equivalence studies --
Meta-analysis -- Cross-over trials -- n-of-1 trials -- Sequential trials -- Dose-finding -- Concerning pharmacokinetics and pharmacodynamics -- Bioequivalence studies -- Safety data, harms, drug monitoring, and pharmaco-epidemiology -- Pharmaco-economics and portfolio management -- Concerning pharmacogenetics, pharmacogenomics, and related matters.
Record Nr. UNINA-9910810135003321
Senn Stephen  
Chichester, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui