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Clinical trial biostatistics and biopharmaceutical applications / / editors, Walter R. Young, Ding-Geng (Din) Chen
| Clinical trial biostatistics and biopharmaceutical applications / / editors, Walter R. Young, Ding-Geng (Din) Chen |
| Pubbl/distr/stampa | Boca Raton : , : CRC Press, , [2015] |
| Descrizione fisica | 1 online resource (574 p.) |
| Disciplina | 610.72/7 |
| Soggetto topico |
Medicine - Research - Statistical methods
Clinical trials - Methodology |
| ISBN |
0-429-17306-7
1-4822-1219-6 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Contents; List of Figures; List of Tables; Preface; Early History of the DemingConference; Some Nonstatistical Reminiscences of My 44 Years of Chairing the Deming Conference; Contributors; Section I: Emerging Issues in ClinicalTrial Design and Analysis; Chapter 1: Emerging Challenges of Clinical Trial Methodologies in Regulatory Applications; Chapter 2: Review of Randomization Methodsin Clinical Trials; Chapter 3: First Dose Ranging Clinical Trial Design:More Doses? Or aWider Range?; Chapter 4: Thorough QT/QTc Clinical Trials
Chapter 5: Controversial (Unresolved) Issues in Noninferiority TrialsSection II: Adaptive Clinical Trials; Chapter 6: Adaptive Designs in Drug Development; Chapter 7: Optimizing Group-Sequential Designs with Focus on Adaptability: Implications of Nonproportional Hazards in Clinical Trials; Chapter 8: Group Sequential Design in R; Section III: Clinical Trials in Oncology; Chapter 9: Issues in the Design and Analysis of Oncology Clinical Trials; Chapter 10: Competing Risks and Their Applications in Cancer Clinical Trials Chapter 11: Dose Finding with Escalation with Overdose Control in Cancer Clinical TrialsChapter 12: Interval-Censored Time-to-Event Data andT heir Applications in Clinical Trials; Section IV: Multiple Comparisons in Clinical Trials; Chapter 13: Introduction to Multiple Test Problems, with Applications to Adaptive Designs; Chapter 14: Graphical Approaches to Multiple Testing; Chapter 15: Pairwise Comparisons with Binary Responses: Multiplicity-Adjusted P-Values and Simultaneous Confidence Intervals Chapter 16: Comparative Study of Five Weighted Parametric Multiple Testing Methods for Correlated Multiple Endpoints in Clinical TrialsSection V: Clinical Trials in a Genomic Era; Chapter 17: Statistical Analysis of Biomarkers from -Omics Technologies; Chapter 18: Understanding Therapeutic Pathways via Biomarkers and Other Uses of Biomarkers in Clinical Studies; Chapter 19: Statistical Evaluation of Surrogate Endpoints in Clinical Studies; Back Cover |
| Record Nr. | UNINA-9910787961903321 |
| Boca Raton : , : CRC Press, , [2015] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Clinical trial biostatistics and biopharmaceutical applications / / editors, Walter R. Young, Ding-Geng (Din) Chen
| Clinical trial biostatistics and biopharmaceutical applications / / editors, Walter R. Young, Ding-Geng (Din) Chen |
| Pubbl/distr/stampa | Boca Raton : , : CRC Press, , [2015] |
| Descrizione fisica | 1 online resource (574 p.) |
| Disciplina | 610.72/7 |
| Soggetto topico |
Medicine - Research - Statistical methods
Clinical trials - Methodology |
| ISBN |
0-429-17306-7
1-4822-1219-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Contents; List of Figures; List of Tables; Preface; Early History of the DemingConference; Some Nonstatistical Reminiscences of My 44 Years of Chairing the Deming Conference; Contributors; Section I: Emerging Issues in ClinicalTrial Design and Analysis; Chapter 1: Emerging Challenges of Clinical Trial Methodologies in Regulatory Applications; Chapter 2: Review of Randomization Methodsin Clinical Trials; Chapter 3: First Dose Ranging Clinical Trial Design:More Doses? Or aWider Range?; Chapter 4: Thorough QT/QTc Clinical Trials
Chapter 5: Controversial (Unresolved) Issues in Noninferiority TrialsSection II: Adaptive Clinical Trials; Chapter 6: Adaptive Designs in Drug Development; Chapter 7: Optimizing Group-Sequential Designs with Focus on Adaptability: Implications of Nonproportional Hazards in Clinical Trials; Chapter 8: Group Sequential Design in R; Section III: Clinical Trials in Oncology; Chapter 9: Issues in the Design and Analysis of Oncology Clinical Trials; Chapter 10: Competing Risks and Their Applications in Cancer Clinical Trials Chapter 11: Dose Finding with Escalation with Overdose Control in Cancer Clinical TrialsChapter 12: Interval-Censored Time-to-Event Data andT heir Applications in Clinical Trials; Section IV: Multiple Comparisons in Clinical Trials; Chapter 13: Introduction to Multiple Test Problems, with Applications to Adaptive Designs; Chapter 14: Graphical Approaches to Multiple Testing; Chapter 15: Pairwise Comparisons with Binary Responses: Multiplicity-Adjusted P-Values and Simultaneous Confidence Intervals Chapter 16: Comparative Study of Five Weighted Parametric Multiple Testing Methods for Correlated Multiple Endpoints in Clinical TrialsSection V: Clinical Trials in a Genomic Era; Chapter 17: Statistical Analysis of Biomarkers from -Omics Technologies; Chapter 18: Understanding Therapeutic Pathways via Biomarkers and Other Uses of Biomarkers in Clinical Studies; Chapter 19: Statistical Evaluation of Surrogate Endpoints in Clinical Studies; Back Cover |
| Record Nr. | UNINA-9910800183903321 |
| Boca Raton : , : CRC Press, , [2015] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Important considerations for clinical trial methodologies / / Vance Berger, Xiao Zhang, editors
| Important considerations for clinical trial methodologies / / Vance Berger, Xiao Zhang, editors |
| Pubbl/distr/stampa | London, England : , : Future Science Ltd, , 2013 |
| Descrizione fisica | 1 online resource (134 pages) : illustrations (some color) |
| Disciplina | 615.19072 |
| Soggetto topico | Clinical trials - Methodology |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-909453-30-7
1-909453-31-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910493184603321 |
| London, England : , : Future Science Ltd, , 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Important considerations for clinical trial methodologies / / Vance Berger, Xiao Zhang, editors
| Important considerations for clinical trial methodologies / / Vance Berger, Xiao Zhang, editors |
| Pubbl/distr/stampa | London, England : , : Future Science Ltd, , 2013 |
| Descrizione fisica | 1 online resource (134 pages) : illustrations (some color) |
| Disciplina | 615.19072 |
| Soggetto topico | Clinical trials - Methodology |
| ISBN |
1-909453-30-7
1-909453-31-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910789329603321 |
| London, England : , : Future Science Ltd, , 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Important considerations for clinical trial methodologies / / Vance Berger, Xiao Zhang, editors
| Important considerations for clinical trial methodologies / / Vance Berger, Xiao Zhang, editors |
| Pubbl/distr/stampa | London, England : , : Future Science Ltd, , 2013 |
| Descrizione fisica | 1 online resource (134 pages) : illustrations (some color) |
| Disciplina | 615.19072 |
| Soggetto topico | Clinical trials - Methodology |
| ISBN |
1-909453-30-7
1-909453-31-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910809225603321 |
| London, England : , : Future Science Ltd, , 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
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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Research methods in community medicine [[electronic resource] ] : surveys, epidemiological research, programme evaluation, clinical trials / / J.H. Abramson, Z.H. Abramson
| Research methods in community medicine [[electronic resource] ] : surveys, epidemiological research, programme evaluation, clinical trials / / J.H. Abramson, Z.H. Abramson |
| Autore | Abramson J. H (Joseph Herbert), <1924-> |
| Edizione | [6th ed.] |
| Pubbl/distr/stampa | Chichester, England ; ; Hoboken, NJ, : Wiley, c2008 |
| Descrizione fisica | 1 online resource (424 p.) |
| Disciplina | 362.1072/3 |
| Altri autori (Persone) |
AbramsonZ. H
AbramsonJ. H <1924-> (Joseph Herbert) |
| Soggetto topico |
Health surveys
Public health - Research - Methodology Community health services - Research - Methodology Epidemiology - Methodology Clinical trials - Methodology |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-119-96416-4
1-282-12390-4 9786612123900 0-470-98723-5 0-470-98722-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Research Methods in Community Medicine; Contents; Preface; 1 First Steps; 2 Types of Investigation; 3 Stages of an Investigation; 4 Formulating the Objectives; 5 The Objectives of Evaluative Studies; 6 The Study Population; 7 Control Groups; 8 Sampling; 9 Selecting Cases and Controls for Case-control Studies; 10 The Variables; 11 Defi ning the Variables; 12 Defi nitions of Diseases; 13 Scales of Measurement; 14 Composite Scales; 15 Methods of Collecting Data; 16 Reliability; 17 Validity; 18 Interviews and Self- Administered Questionnaires; 19 Constructing a Questionnaire
20 Surveying the Opinions of a Panel: Consensus Methods21 The Use of Documentary Sources; 22 Planning the Records; 23 Planning the Handling of Data; 24 Pretests and Other Preparations; 25 Collecting the Data; 26 Statistical Analysis; 27 Interpreting the Findings; 28 Making Sense of Associations; 29 Application of the Study Findings; 30 Writing a Report; 31 Rapid Epidemiological Methods; 32 Clinical Trials; 33 Programme Trials; 34 Community-Oriented Primary Care; 35 Using the Web for Health Research; Appendix A Community Appraisal: A Checklist; Appendix B Random Numbers Appendix C Free Computer ProgramsIndex |
| Record Nr. | UNINA-9910144849103321 |
|
Abramson J. H (Joseph Herbert), <1924->
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| Chichester, England ; ; Hoboken, NJ, : Wiley, c2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Research methods in community medicine [[electronic resource] ] : surveys, epidemiological research, programme evaluation, clinical trials / / J.H. Abramson, Z.H. Abramson
| Research methods in community medicine [[electronic resource] ] : surveys, epidemiological research, programme evaluation, clinical trials / / J.H. Abramson, Z.H. Abramson |
| Autore | Abramson J. H (Joseph Herbert), <1924-> |
| Edizione | [6th ed.] |
| Pubbl/distr/stampa | Chichester, England ; ; Hoboken, NJ, : Wiley, c2008 |
| Descrizione fisica | 1 online resource (424 p.) |
| Disciplina | 362.1072/3 |
| Altri autori (Persone) |
AbramsonZ. H
AbramsonJ. H <1924-> (Joseph Herbert) |
| Soggetto topico |
Health surveys
Public health - Research - Methodology Community health services - Research - Methodology Epidemiology - Methodology Clinical trials - Methodology |
| ISBN |
1-119-96416-4
1-282-12390-4 9786612123900 0-470-98723-5 0-470-98722-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Research Methods in Community Medicine; Contents; Preface; 1 First Steps; 2 Types of Investigation; 3 Stages of an Investigation; 4 Formulating the Objectives; 5 The Objectives of Evaluative Studies; 6 The Study Population; 7 Control Groups; 8 Sampling; 9 Selecting Cases and Controls for Case-control Studies; 10 The Variables; 11 Defi ning the Variables; 12 Defi nitions of Diseases; 13 Scales of Measurement; 14 Composite Scales; 15 Methods of Collecting Data; 16 Reliability; 17 Validity; 18 Interviews and Self- Administered Questionnaires; 19 Constructing a Questionnaire
20 Surveying the Opinions of a Panel: Consensus Methods21 The Use of Documentary Sources; 22 Planning the Records; 23 Planning the Handling of Data; 24 Pretests and Other Preparations; 25 Collecting the Data; 26 Statistical Analysis; 27 Interpreting the Findings; 28 Making Sense of Associations; 29 Application of the Study Findings; 30 Writing a Report; 31 Rapid Epidemiological Methods; 32 Clinical Trials; 33 Programme Trials; 34 Community-Oriented Primary Care; 35 Using the Web for Health Research; Appendix A Community Appraisal: A Checklist; Appendix B Random Numbers Appendix C Free Computer ProgramsIndex |
| Record Nr. | UNINA-9910830446203321 |
|
Abramson J. H (Joseph Herbert), <1924->
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||
| Chichester, England ; ; Hoboken, NJ, : Wiley, c2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Research methods in community medicine : surveys, epidemiological research, programme evaluation, clinical trials / / J.H. Abramson, Z.H. Abramson
| Research methods in community medicine : surveys, epidemiological research, programme evaluation, clinical trials / / J.H. Abramson, Z.H. Abramson |
| Autore | Abramson J. H (Joseph Herbert), <1924-> |
| Edizione | [6th ed.] |
| Pubbl/distr/stampa | Chichester, England ; ; Hoboken, NJ, : Wiley, c2008 |
| Descrizione fisica | 1 online resource (424 p.) |
| Disciplina | 362.1072/3 |
| Altri autori (Persone) |
AbramsonZ. H
AbramsonJ. H <1924-> (Joseph Herbert) |
| Soggetto topico |
Health surveys
Public health - Research - Methodology Community health services - Research - Methodology Epidemiology - Methodology Clinical trials - Methodology |
| ISBN |
9786612123900
9781119964162 1119964164 9781282123908 1282123904 9780470987230 0470987235 9780470987223 0470987227 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Research Methods in Community Medicine; Contents; Preface; 1 First Steps; 2 Types of Investigation; 3 Stages of an Investigation; 4 Formulating the Objectives; 5 The Objectives of Evaluative Studies; 6 The Study Population; 7 Control Groups; 8 Sampling; 9 Selecting Cases and Controls for Case-control Studies; 10 The Variables; 11 Defi ning the Variables; 12 Defi nitions of Diseases; 13 Scales of Measurement; 14 Composite Scales; 15 Methods of Collecting Data; 16 Reliability; 17 Validity; 18 Interviews and Self- Administered Questionnaires; 19 Constructing a Questionnaire
20 Surveying the Opinions of a Panel: Consensus Methods21 The Use of Documentary Sources; 22 Planning the Records; 23 Planning the Handling of Data; 24 Pretests and Other Preparations; 25 Collecting the Data; 26 Statistical Analysis; 27 Interpreting the Findings; 28 Making Sense of Associations; 29 Application of the Study Findings; 30 Writing a Report; 31 Rapid Epidemiological Methods; 32 Clinical Trials; 33 Programme Trials; 34 Community-Oriented Primary Care; 35 Using the Web for Health Research; Appendix A Community Appraisal: A Checklist; Appendix B Random Numbers Appendix C Free Computer ProgramsIndex |
| Record Nr. | UNINA-9911019566403321 |
|
Abramson J. H (Joseph Herbert), <1924->
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| Chichester, England ; ; Hoboken, NJ, : Wiley, c2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Self-controlled case series studies : a modelling guide with R / / by Paddy Farrington, Heather Whitaker, Yonas Ghebremichael Weldeselassie
| Self-controlled case series studies : a modelling guide with R / / by Paddy Farrington, Heather Whitaker, Yonas Ghebremichael Weldeselassie |
| Autore | Farrington Paddy |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Boca Raton, Florida : , : CRC Press, , 2018 |
| Descrizione fisica | 1 online resource (377 pages) |
| Disciplina | 610.72/4 |
| Soggetto topico |
Medicine - Research - Methodology
Clinical trials - Methodology |
| ISBN |
0-429-95751-3
0-429-95752-1 0-429-49131-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | chapter 1 Introduction / Paddy Farrington Heather Whitaker Yonas Ghebremichael Weldeselassie -- chapter 2 Epidemiological overview / Paddy Farrington Heather Whitaker Yonas Ghebremichael Weldeselassie -- chapter 3 The SCCS likelihood / Paddy Farrington Heather Whitaker Yonas Ghebremichael Weldeselassie -- chapter 4 The standard SCCS model / Paddy Farrington Heather Whitaker Yonas Ghebremichael Weldeselassie -- chapter 5 Checking model assumptions / Paddy Farrington Heather Whitaker Yonas Ghebremichael Weldeselassie -- chapter 6 Further SCCS models / Paddy Farrington Heather Whitaker Yonas Ghebremichael Weldeselassie -- chapter 7 Extensions of the SCCS model / Paddy Farrington Heather Whitaker Yonas Ghebremichael Weldeselassie -- chapter 8 Design and presentation of SCCS studies / Paddy Farrington Heather Whitaker Yonas Ghebremichael Weldeselassie. |
| Record Nr. | UNINA-9910872399003321 |
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Farrington Paddy
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| Boca Raton, Florida : , : CRC Press, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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