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Biblioteca

MARC Lista (tabellare)
Data monitoring committees in clinical trials : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David I. DeMets
Data monitoring committees in clinical trials : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David I. DeMets
Autore Ellenberg Susan Smith
Edizione [Second edition.]
Pubbl/distr/stampa Hoboken, NJ : , : Wiley, , 2019
Descrizione fisica 1 online resource (493 pages)
Disciplina 610.72/4
Collana Statistics in practice
Soggetto genere / forma Electronic books.
ISBN 1-119-51268-9
1-119-51264-6
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Responsibilities of the data monitoring committee and motivating illustrations -- Composition of a data monitoring committee -- Independence of the data monitoring committee : avoiding conflicts of interest -- Confidentiality issues relating to the data monitoring committee -- Data monitoring committee meetings -- Data monitoring committee interactions with other trial components or related groups -- Statistical, philosophical and ethical issues in data monitoring -- Determining when a data monitoring committee is needed -- Regulatory considerations for the operation of data monitoring committees -- Legal considerations for DMCs.
Record Nr. UNINA-9910467635603321
Ellenberg Susan Smith  
Hoboken, NJ : , : Wiley, , 2019
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Data monitoring committees in clinical trials : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David I. DeMets
Data monitoring committees in clinical trials : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David I. DeMets
Autore Ellenberg Susan Smith
Edizione [Second edition.]
Pubbl/distr/stampa Hoboken, NJ : , : Wiley, , 2019
Descrizione fisica 1 online resource (493 pages)
Disciplina 610.72/4
Collana Statistics in practice
Soggetto topico Clinical trials
Data collection platforms
Soggetto non controllato Clinical Trials
Medical
ISBN 1-119-51267-0
1-119-51268-9
1-119-51264-6
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Responsibilities of the data monitoring committee and motivating illustrations -- Composition of a data monitoring committee -- Independence of the data monitoring committee : avoiding conflicts of interest -- Confidentiality issues relating to the data monitoring committee -- Data monitoring committee meetings -- Data monitoring committee interactions with other trial components or related groups -- Statistical, philosophical and ethical issues in data monitoring -- Determining when a data monitoring committee is needed -- Regulatory considerations for the operation of data monitoring committees -- Legal considerations for DMCs.
Record Nr. UNINA-9910538819403321
Ellenberg Susan Smith  
Hoboken, NJ : , : Wiley, , 2019
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Data monitoring committees in clinical trials : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David I. DeMets
Data monitoring committees in clinical trials : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David I. DeMets
Autore Ellenberg Susan Smith
Edizione [Second edition.]
Pubbl/distr/stampa Hoboken, NJ : , : Wiley, , 2019
Descrizione fisica 1 online resource (493 pages)
Disciplina 610.72/4
Collana Statistics in practice
Soggetto topico Clinical trials
Data collection platforms
Soggetto non controllato Clinical Trials
Medical
ISBN 1-119-51267-0
1-119-51268-9
1-119-51264-6
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Responsibilities of the data monitoring committee and motivating illustrations -- Composition of a data monitoring committee -- Independence of the data monitoring committee : avoiding conflicts of interest -- Confidentiality issues relating to the data monitoring committee -- Data monitoring committee meetings -- Data monitoring committee interactions with other trial components or related groups -- Statistical, philosophical and ethical issues in data monitoring -- Determining when a data monitoring committee is needed -- Regulatory considerations for the operation of data monitoring committees -- Legal considerations for DMCs.
Record Nr. UNINA-9910826460803321
Ellenberg Susan Smith  
Hoboken, NJ : , : Wiley, , 2019
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
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
Opac: Controlla la disponibilità qui
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
Opac: Controlla la disponibilità qui
Data monitoring committees in clinical trials : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets
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
Opac: Controlla la disponibilità qui