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Data monitoring committees in clinical trials [[electronic resource] ] : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets
| Data monitoring committees in clinical trials [[electronic resource] ] : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets |
| Autore | Ellenberg Susan Smith |
| Pubbl/distr/stampa | Chichester ; ; Hoboken, NJ, : Wiley, c2002 |
| Descrizione fisica | 1 online resource (209 p.) |
| Disciplina |
610/.72/4
615.190072 |
| Altri autori (Persone) |
FlemingThomas R
DeMetsDavid L. <1944-> |
| Collana | Statistics in practice |
| Soggetto topico |
Clinical trials
Medical ethics committees |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-26999-5
9786610269990 0-470-32228-4 0-470-85415-4 0-470-85416-2 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Data Monitoring Committees in Clinical Trials A Practical Perspective; Contents; Preface; 1 Introduction; 1.1 Motivation; 1.2 History of data monitoring committees in government-sponsored trials; 1.3 Data monitoring committees in trials sponsored by the pharmaceutical industry; 1.4 Statistical methods for interim monitoring; 1.5 When are data monitoring committees needed?; 1.6 Where we are today; 1.7 Fundamental principles of data monitoring; References; 2 Responsibilities of the data monitoring committee and motivating illustrations; 2.1 Fundamental charges
2.2 Specific tasks of the data monitoring committee 2.2.1 Initial review; 2.2.1.1 Review of the study protocol; 2.2.1.2 Review of procedures to ensure quality of study conduct; 2.2.2 Evaluating the quality of ongoing study conduct; 2.2.3 Assessing safety and efficacy data; 2.2.3.1 Termination due to favorable benefit-to-risk; 2.2.3.2 Termination due to unfavorable benefit-to-risk; 2.2.3.3 Termination due to inability to answer trial questions; 2.2.3.4 Continuation of ongoing clinical trials; 2.2.3.5 Consideration of the overall picture: primary and secondary analyses 2.2.3.6 Modifying sample sizes based on ongoing assessment of event rates 2.2.4 Reviewing the final results; 2.3 The data monitoring committee charter; References; 3 Composition of a data monitoring committee; 3.1 Introduction; 3.2 Required areas of expertise; 3.3 Other relevant characteristics of committee members; 3.4 Committee size; 3.5 Selecting the committee chair; 3.6 Responsibility for appointing committee members; 3.7 Representation of other study components on the committee; 3.8 Preparation for service on a committee; References 4 Independence of the data monitoring committee: avoiding conflicts of interest 4.1 Introduction; 4.2 Rationale for independence; 4.3 Financial independence; 4.3.1 Sponsors; 4.3.2 Academic investigators; 4.4 Intellectual independence; 4.5 Emotional conflicts; 4.6 Individuals without conflicts; References; 5 Confidentiality issues relating to the data monitoring committee; 5.1 Rationale; 5.2 Limits of confidentiality; 5.2.1 Interim analysis reports; 5.2.2 Access to aggregate data on efficacy and safety outcomes; 5.2.3 The steering committee and maintaining confidentiality 5.2.4 Settings and procedures allowing broader unblinding 5.2.5 Some illustrations of broader unblinding; 5.2.6 Indirect challenges to confidentiality; 5.3 The need for the data monitoring committee to review unblinded data; References; 6 Data monitoring committee meetings; 6.1 Introduction; 6.2 Specific objectives and timing of meetings; 6.2.1 Organizational meeting; 6.2.2 Early safety/trial integrity reviews; 6.2.3 Formal interim efficacy analyses; 6.2.4 End-of-trial debriefing; 6.3 Preparation of meeting reports; 6.4 Format for meetings; 6.4.1 The closed session; 6.4.2 The open session 6.4.3 The final closed session |
| Record Nr. | UNINA-9910142496903321 |
Ellenberg Susan Smith
|
||
| Chichester ; ; Hoboken, NJ, : Wiley, c2002 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Data monitoring committees in clinical trials [[electronic resource] ] : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets
| Data monitoring committees in clinical trials [[electronic resource] ] : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets |
| Autore | Ellenberg Susan Smith |
| Pubbl/distr/stampa | Chichester ; ; Hoboken, NJ, : Wiley, c2002 |
| Descrizione fisica | 1 online resource (209 p.) |
| Disciplina |
610/.72/4
615.190072 |
| Altri autori (Persone) |
FlemingThomas R
DeMetsDavid L. <1944-> |
| Collana | Statistics in practice |
| Soggetto topico |
Clinical trials
Medical ethics committees |
| ISBN |
1-280-26999-5
9786610269990 0-470-32228-4 0-470-85415-4 0-470-85416-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Data Monitoring Committees in Clinical Trials A Practical Perspective; Contents; Preface; 1 Introduction; 1.1 Motivation; 1.2 History of data monitoring committees in government-sponsored trials; 1.3 Data monitoring committees in trials sponsored by the pharmaceutical industry; 1.4 Statistical methods for interim monitoring; 1.5 When are data monitoring committees needed?; 1.6 Where we are today; 1.7 Fundamental principles of data monitoring; References; 2 Responsibilities of the data monitoring committee and motivating illustrations; 2.1 Fundamental charges
2.2 Specific tasks of the data monitoring committee 2.2.1 Initial review; 2.2.1.1 Review of the study protocol; 2.2.1.2 Review of procedures to ensure quality of study conduct; 2.2.2 Evaluating the quality of ongoing study conduct; 2.2.3 Assessing safety and efficacy data; 2.2.3.1 Termination due to favorable benefit-to-risk; 2.2.3.2 Termination due to unfavorable benefit-to-risk; 2.2.3.3 Termination due to inability to answer trial questions; 2.2.3.4 Continuation of ongoing clinical trials; 2.2.3.5 Consideration of the overall picture: primary and secondary analyses 2.2.3.6 Modifying sample sizes based on ongoing assessment of event rates 2.2.4 Reviewing the final results; 2.3 The data monitoring committee charter; References; 3 Composition of a data monitoring committee; 3.1 Introduction; 3.2 Required areas of expertise; 3.3 Other relevant characteristics of committee members; 3.4 Committee size; 3.5 Selecting the committee chair; 3.6 Responsibility for appointing committee members; 3.7 Representation of other study components on the committee; 3.8 Preparation for service on a committee; References 4 Independence of the data monitoring committee: avoiding conflicts of interest 4.1 Introduction; 4.2 Rationale for independence; 4.3 Financial independence; 4.3.1 Sponsors; 4.3.2 Academic investigators; 4.4 Intellectual independence; 4.5 Emotional conflicts; 4.6 Individuals without conflicts; References; 5 Confidentiality issues relating to the data monitoring committee; 5.1 Rationale; 5.2 Limits of confidentiality; 5.2.1 Interim analysis reports; 5.2.2 Access to aggregate data on efficacy and safety outcomes; 5.2.3 The steering committee and maintaining confidentiality 5.2.4 Settings and procedures allowing broader unblinding 5.2.5 Some illustrations of broader unblinding; 5.2.6 Indirect challenges to confidentiality; 5.3 The need for the data monitoring committee to review unblinded data; References; 6 Data monitoring committee meetings; 6.1 Introduction; 6.2 Specific objectives and timing of meetings; 6.2.1 Organizational meeting; 6.2.2 Early safety/trial integrity reviews; 6.2.3 Formal interim efficacy analyses; 6.2.4 End-of-trial debriefing; 6.3 Preparation of meeting reports; 6.4 Format for meetings; 6.4.1 The closed session; 6.4.2 The open session 6.4.3 The final closed session |
| Record Nr. | UNINA-9910829980403321 |
|
Ellenberg Susan Smith
|
||
| Chichester ; ; Hoboken, NJ, : Wiley, c2002 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Data monitoring committees in clinical trials [[electronic resource] ] : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets
| Data monitoring committees in clinical trials [[electronic resource] ] : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets |
| Autore | Ellenberg Susan Smith |
| Pubbl/distr/stampa | Chichester ; ; Hoboken, NJ, : Wiley, c2002 |
| Descrizione fisica | 1 online resource (209 p.) |
| Disciplina |
610/.72/4
615.190072 |
| Altri autori (Persone) |
FlemingThomas R
DeMetsDavid L. <1944-> |
| Collana | Statistics in practice |
| Soggetto topico |
Clinical trials
Medical ethics committees |
| ISBN |
1-280-26999-5
9786610269990 0-470-32228-4 0-470-85415-4 0-470-85416-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Data Monitoring Committees in Clinical Trials A Practical Perspective; Contents; Preface; 1 Introduction; 1.1 Motivation; 1.2 History of data monitoring committees in government-sponsored trials; 1.3 Data monitoring committees in trials sponsored by the pharmaceutical industry; 1.4 Statistical methods for interim monitoring; 1.5 When are data monitoring committees needed?; 1.6 Where we are today; 1.7 Fundamental principles of data monitoring; References; 2 Responsibilities of the data monitoring committee and motivating illustrations; 2.1 Fundamental charges
2.2 Specific tasks of the data monitoring committee 2.2.1 Initial review; 2.2.1.1 Review of the study protocol; 2.2.1.2 Review of procedures to ensure quality of study conduct; 2.2.2 Evaluating the quality of ongoing study conduct; 2.2.3 Assessing safety and efficacy data; 2.2.3.1 Termination due to favorable benefit-to-risk; 2.2.3.2 Termination due to unfavorable benefit-to-risk; 2.2.3.3 Termination due to inability to answer trial questions; 2.2.3.4 Continuation of ongoing clinical trials; 2.2.3.5 Consideration of the overall picture: primary and secondary analyses 2.2.3.6 Modifying sample sizes based on ongoing assessment of event rates 2.2.4 Reviewing the final results; 2.3 The data monitoring committee charter; References; 3 Composition of a data monitoring committee; 3.1 Introduction; 3.2 Required areas of expertise; 3.3 Other relevant characteristics of committee members; 3.4 Committee size; 3.5 Selecting the committee chair; 3.6 Responsibility for appointing committee members; 3.7 Representation of other study components on the committee; 3.8 Preparation for service on a committee; References 4 Independence of the data monitoring committee: avoiding conflicts of interest 4.1 Introduction; 4.2 Rationale for independence; 4.3 Financial independence; 4.3.1 Sponsors; 4.3.2 Academic investigators; 4.4 Intellectual independence; 4.5 Emotional conflicts; 4.6 Individuals without conflicts; References; 5 Confidentiality issues relating to the data monitoring committee; 5.1 Rationale; 5.2 Limits of confidentiality; 5.2.1 Interim analysis reports; 5.2.2 Access to aggregate data on efficacy and safety outcomes; 5.2.3 The steering committee and maintaining confidentiality 5.2.4 Settings and procedures allowing broader unblinding 5.2.5 Some illustrations of broader unblinding; 5.2.6 Indirect challenges to confidentiality; 5.3 The need for the data monitoring committee to review unblinded data; References; 6 Data monitoring committee meetings; 6.1 Introduction; 6.2 Specific objectives and timing of meetings; 6.2.1 Organizational meeting; 6.2.2 Early safety/trial integrity reviews; 6.2.3 Formal interim efficacy analyses; 6.2.4 End-of-trial debriefing; 6.3 Preparation of meeting reports; 6.4 Format for meetings; 6.4.1 The closed session; 6.4.2 The open session 6.4.3 The final closed session |
| Record Nr. | UNINA-9910841429703321 |
|
Ellenberg Susan Smith
|
||
| Chichester ; ; Hoboken, NJ, : Wiley, c2002 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials [[electronic resource] /] / edited by Thomas R. Fleming, Bruce S. Weir
| Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials [[electronic resource] /] / edited by Thomas R. Fleming, Bruce S. Weir |
| Edizione | [1st ed. 2013.] |
| Pubbl/distr/stampa | New York, NY : , : Springer New York : , : Imprint : Springer, , 2013 |
| Descrizione fisica | 1 online resource (244 p.) |
| Disciplina |
570.1
570.1/5195 |
| Collana | Lecture Notes in Statistics - Proceedings |
| Soggetto topico |
Statistics
Statistics, general Statistics for Life Sciences, Medicine, Health Sciences |
| ISBN |
1-283-93395-0
1-4614-5245-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials; Preface; Contents; Part I Biomarkers: Role in the Design and Interpretation of Clinical Trials; The Role and Potential of Surrogate Outcomes in Clinical Trials: Have We Made Any Progress in the Past Decade?; 1 Introduction; 2 Basic Requirements for a Potential Surrogate; 3 Some Earlier Examples; 4 Lipid-Lowering Interventions; 5 Other Recent Examples; 6 Summary; References; On the Use of Biomarkers to Elucidate Clinical Trial Results: Examples from the Women's Health Initiative; 1 Introduction
2 Biomarkers and Variations in Clinical Trial Intervention Effects3 Biomarkers of Intervention Adherence and Exposure; 4 Biomarkers as Mediators of Clinical Trial Intervention Effects; 5 Biomarkers for Intervention Development; 6 Discussion and Summary; References; On the Use of Biomarkers in Vaccine Research and Development; 1 Introduction; 2 Immune Response to Vaccines; 3 Presence and Specificity of the Target Pathogen; 4 Summary; References; Part II Biomarkers: Issues in Individualized Therapy Recent Developments in the Use of Clinical Trials to Support Individualizing Therapies: A Regulatory Perspective1 Introduction; 2 A Definition of Individualized Therapy; 3 A Rich Statistical History of Modeling and Identifying Risk Factors Associated with Differential Outcomes: Response Or Risk; 4 Prediction and Predictive Factors in Randomized Clinical Trials; 5 A Related Topic: Dealing with Differential Treatment Response Associated with Ethnic Factors: The Role of the ICH E5 Guidance on Acceptance of Foreign Clinical Data 6 Some Recent Examples of Treatment Effects Related to Individual Or Patient Level Covariates7 Replication of Results of Differential Treatment Effects in Enriched and Non-Enriched Subpopulations: Why?; 8 Potential Impact of Prognostic Factor Imbalances in Retrospectively Identified Treatment/Marker Subgroups; 9 Genetic Changes Over the Course of Treatment Or Disease Progression: Impact on Inferences and Design; 10 Study Designs to Evaluate Targeted Therapy; 11 Summary; References; Oncology Clinical Trials in the Genomic Era; 1 Introduction; 2 Targeted (Enrichment) Designs 3 Biomarker Stratified Design4 Designs That Evaluate a Small Number of Classifiers; 5 Predictive Analysis of Clinical Trials; 6 Conclusion; References; Using SNPs to Characterize Genetic Effects in Clinical Trials; 1 Introduction; 2 SNP Data; 3 Cleaning SNP Data; 3.1 SNP-Level Cleaning; 3.2 Individual-Level Cleaning; 4 Association Testing; 5 HLA Typing; 6 Discussion; References; Part III Issues in Multi-Regional Clinical Trials; Why Is This Subgroup Different from All Other Subgroups? Thoughts on Regional Differences in Randomized Clinical Trials; 1 Introduction 2 Why Involve Participants from Many Countries? |
| Record Nr. | UNINA-9910438147303321 |
| New York, NY : , : Springer New York : , : Imprint : Springer, , 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||