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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  
Cham, Switzerland : , : Springer, , [2020]
Materiale a stampa
Lo trovi qui: Univ. di Salerno
Opac: Controlla la disponibilità qui
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. UNINA-9910484552403321
Kieser Meinhard  
Cham, Switzerland : , : Springer, , [2020]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui