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Methods and applications of sample size calculation and recalculation in clinical trials / / Meinhard Kieser
| Methods and applications of sample size calculation and recalculation in clinical trials / / Meinhard Kieser |
| Autore | Kieser Meinhard |
| Edizione | [1st ed. 2020.] |
| Pubbl/distr/stampa | Cham, Switzerland : , : Springer, , [2020] |
| Descrizione fisica | 1 online resource (XIV, 396 p. 126 illus.) |
| Disciplina | 615.19 |
| Collana | Springer series in pharmaceutical statistics |
| Soggetto topico |
Pharmaceutical technology
Clinical trials - Research Clinical trials - Methodology |
| ISBN | 3-030-49528-0 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Part I: Basics -- Chapter 1- Introduction -- Chapter 2 - Statistical test and sample size calculation -- Part II : Sample size calculation -- Chapter 3 - Comparison of two groups for normally distributed outcomes and test for difference or superiority.-Chapter 4 - Comparison of two groups for continuous and ordered categorical outcomes and test for difference or superiority -- Chapter 5 - Comparison of two groups for binary outcomes and test for difference and superiority -- Chapter 6 - Comparison of two groups for time-to-event outcomes and test for differences or superiority -- Chapter 7 - Comparison of more than two groups and test for difference -- Chapter 8 - Comparison of two groups and test for non-inferiority -- Chapter 9 - Comparison of three groups in the gold standard non-inferiority design -- Chapter 10 - Comparison of two groups for normally distributed outcomes and test for equivalence -- Chapter 11 - Multiple comparisons -- Chapter 12 - Assessment of safety -- Chapter 13 - Cluster-randomized trials -- Chapter 14 - Multi-regional trials -- Chapter 15 - Integrated planning of phase II/III drug development programs -- Chapter 16 - Simulation-based sample size calculation -- Part III: Sample size recalculation -- Chapter 17 – Background -- Part IIIA: Blinded sample size recalculation in internal pilot study designs -- Chapter 18 - Background and notation -- Chapter 19 - A general approach for controlling the type I error rate for blinded sample size recalculation.-Chapter 20 - Comparison of two groups for normally distributed outcomes and test for difference or superiority -- Chapter 21 - Comparison of two groups for binary outcomes and test for difference or superiority -- Chapter 22 - Comparison of two groups for normally distributed outcomes and test for non-inferiority -- Chapter 23 - Comparison of two groups for binary outcomes and test for non-inferiority -- Chapter 24 - Comparison of two groups for normally distributed outcomes and test for equivalence.-Chapter 25 - Regulatory and operational aspects -- Chapter 26 - Concluding remarks.-Part IIIB: Unblinded sample size recalculation in adaptive designs -- Chapter 27 - Background and notation -- Chapter 28 - Sample size recalculation based on conditional power -- Chapter 29 - Sample size recalculation by optimization -- Chapter 30 - Regulatory and operational aspects -- Chapter 31 - Concluding remarks. |
| Record Nr. | UNISA-996418192103316 |
Kieser Meinhard
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| Cham, Switzerland : , : Springer, , [2020] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials / / by Meinhard Kieser
| Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials / / by Meinhard Kieser |
| Autore | Kieser Meinhard |
| Edizione | [1st ed. 2020.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020 |
| Descrizione fisica | 1 online resource (XIV, 396 p. 126 illus.) |
| Disciplina | 615.19 |
| Collana | Springer Series in Pharmaceutical Statistics |
| Soggetto topico |
Statistics
Biometry Pharmaceutical chemistry Statistical Theory and Methods Biostatistics Pharmaceutics |
| ISBN |
9783030495282
3030495280 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Part I: Basics -- Chapter 1- Introduction -- Chapter 2 - Statistical test and sample size calculation -- Part II : Sample size calculation -- Chapter 3 - Comparison of two groups for normally distributed outcomes and test for difference or superiority.-Chapter 4 - Comparison of two groups for continuous and ordered categorical outcomes and test for difference or superiority -- Chapter 5 - Comparison of two groups for binary outcomes and test for difference and superiority -- Chapter 6 - Comparison of two groups for time-to-event outcomes and test for differences or superiority -- Chapter 7 - Comparison of more than two groups and test for difference -- Chapter 8 - Comparison of two groups and test for non-inferiority -- Chapter 9 - Comparison of three groups in the gold standard non-inferiority design -- Chapter 10 - Comparison of two groups for normally distributed outcomes and test for equivalence -- Chapter 11 - Multiple comparisons -- Chapter 12 - Assessment of safety -- Chapter 13 - Cluster-randomized trials -- Chapter 14 - Multi-regional trials -- Chapter 15 - Integrated planning of phase II/III drug development programs -- Chapter 16 - Simulation-based sample size calculation -- Part III: Sample size recalculation -- Chapter 17 – Background -- Part IIIA: Blinded sample size recalculation in internal pilot study designs -- Chapter 18 - Background and notation -- Chapter 19 - A general approach for controlling the type I error rate for blinded sample size recalculation.-Chapter 20 - Comparison of two groups for normally distributed outcomes and test for difference or superiority -- Chapter 21 - Comparison of two groups for binary outcomes and test for difference or superiority -- Chapter 22 - Comparison of two groups for normally distributed outcomes and test for non-inferiority -- Chapter 23 - Comparison of two groups for binary outcomes and test for non-inferiority -- Chapter 24 - Comparison of two groups for normally distributed outcomes and test for equivalence.-Chapter 25 - Regulatory and operational aspects -- Chapter 26 - Concluding remarks.-Part IIIB: Unblinded sample size recalculation in adaptive designs -- Chapter 27 - Background and notation -- Chapter 28 - Sample size recalculation based on conditional power -- Chapter 29 - Sample size recalculation by optimization -- Chapter 30 - Regulatory and operational aspects -- Chapter 31 - Concluding remarks. |
| Record Nr. | UNINA-9910484552403321 |
|
Kieser Meinhard
|
||
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||