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 |
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 : 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-9910876994903321 |
Ellenberg Susan Smith | ||
Chichester ; ; Hoboken, NJ, : Wiley, c2002 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Deriving drug discovery value from large-scale genetic bioresources : proceedings of a workshop / / Siobhan Addie [and three others] |
Autore | Addie Siobhan |
Pubbl/distr/stampa | Washington, District of Columbia : , : The National Academies Press, , 2016 |
Descrizione fisica | 1 online resource (115 pages) : illustrations, tables |
Disciplina | 615.190072 |
Soggetto topico |
Drug development
Drugs - Research |
ISBN |
0-309-44781-X
0-309-44779-8 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Record Nr. | UNINA-9910794825603321 |
Addie Siobhan | ||
Washington, District of Columbia : , : The National Academies Press, , 2016 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Deriving drug discovery value from large-scale genetic bioresources : proceedings of a workshop / / Siobhan Addie [and three others] |
Autore | Addie Siobhan |
Pubbl/distr/stampa | Washington, District of Columbia : , : The National Academies Press, , 2016 |
Descrizione fisica | 1 online resource (115 pages) : illustrations, tables |
Disciplina | 615.190072 |
Soggetto topico |
Drug development
Drugs - Research |
ISBN |
0-309-44781-X
0-309-44779-8 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Record Nr. | UNINA-9910826649503321 |
Addie Siobhan | ||
Washington, District of Columbia : , : The National Academies Press, , 2016 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Deriving drug discovery value from large-scale genetic bioresources : proceedings of a workshop / / Siobhan Addie [and three others] |
Pubbl/distr/stampa | Washington, District of Columbia : , : The National Academies Press, , 2016 |
Descrizione fisica | 1 online resource (115 pages) : illustrations, tables |
Disciplina | 615.190072 |
Soggetto topico |
Drug development
Drugs - Research |
Soggetto genere / forma | Electronic books. |
ISBN | 0-309-44779-8 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Record Nr. | UNINA-9910154625003321 |
Washington, District of Columbia : , : The National Academies Press, , 2016 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Enabling precision medicine : the role of genetics in clinical drug development : proceedings of a workshop / / Morgan L. Boname [and four others], rapporteurs |
Pubbl/distr/stampa | Washington, District of Columbia : , : The National Academies Press, , 2017 |
Descrizione fisica | 1 online resource (122 pages) : illustrations (some color) |
Disciplina | 615.190072 |
Soggetto topico |
Drug development
Personalized medicine Pharmacogenetics |
Soggetto genere / forma | Electronic books. |
ISBN | 0-309-46264-9 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Record Nr. | UNINA-9910480251403321 |
Washington, District of Columbia : , : The National Academies Press, , 2017 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Enabling precision medicine : the role of genetics in clinical drug development : proceedings of a workshop / / Morgan L. Boname [and four others], rapporteurs |
Pubbl/distr/stampa | Washington, District of Columbia : , : The National Academies Press, , 2017 |
Descrizione fisica | 1 online resource (122 pages) : illustrations (some color) |
Disciplina | 615.190072 |
Soggetto topico |
Drug development
Precision medicine Pharmacogenetics |
ISBN |
0-309-46266-5
0-309-46264-9 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Introduction -- Overarching considerations for implementing successful genetics-enabled drug development -- Case studies in precision drug development -- Integrating genetics into the drug development pathway for complex diseases -- Finding innovative ways to integrate genetic research into the drug development process -- Reflecting back and looking forward: key themes and potential next steps in genetics-enabled drug development -- Appendix A: References -- Appendix B: Statement of task and workshop agenda -- Appendix C: Speaker biographical sketches -- Appendix D: Registered attendees. |
Record Nr. | UNINA-9910795596603321 |
Washington, District of Columbia : , : The National Academies Press, , 2017 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Enabling precision medicine : the role of genetics in clinical drug development : proceedings of a workshop / / Morgan L. Boname [and four others], rapporteurs |
Pubbl/distr/stampa | Washington, District of Columbia : , : The National Academies Press, , 2017 |
Descrizione fisica | 1 online resource (122 pages) : illustrations (some color) |
Disciplina | 615.190072 |
Soggetto topico |
Drug development
Precision medicine Pharmacogenetics |
ISBN |
0-309-46266-5
0-309-46264-9 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Introduction -- Overarching considerations for implementing successful genetics-enabled drug development -- Case studies in precision drug development -- Integrating genetics into the drug development pathway for complex diseases -- Finding innovative ways to integrate genetic research into the drug development process -- Reflecting back and looking forward: key themes and potential next steps in genetics-enabled drug development -- Appendix A: References -- Appendix B: Statement of task and workshop agenda -- Appendix C: Speaker biographical sketches -- Appendix D: Registered attendees. |
Record Nr. | UNINA-9910825360303321 |
Washington, District of Columbia : , : The National Academies Press, , 2017 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Pharmacophores and pharmacophore searches / edited by Thierry Langer and Rémy D. Hoffmann |
Pubbl/distr/stampa | Weinheim, : Wiley-VCH, c2006 |
Descrizione fisica | XX, 375 p. : ill. ; 25 cm. |
Disciplina |
615
615.190072 |
Collana | Methods and principles in medicinal chemistry |
Soggetto topico | Medicinali - Analisi qualitativa |
ISBN |
3527312501
9783527312504 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Record Nr. | UNISANNIO-PUV1089792 |
Weinheim, : Wiley-VCH, c2006 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. del Sannio | ||
|