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 [[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 | ||
|
Guidance for healthcare ethics committees / / edited by D. Micah Hester, Toby Schonfeld [[electronic resource]] |
Pubbl/distr/stampa | Cambridge : , : Cambridge University Press, , 2012 |
Descrizione fisica | 1 online resource (xiii, 185 pages) : digital, PDF file(s) |
Disciplina | 174.2 |
Soggetto topico |
Medical ethics committees
Medical ethics |
ISBN |
1-139-50780-X
1-107-22395-4 9786613684646 1-139-51477-6 1-139-51642-6 1-139-51384-2 1-280-77387-1 1-139-51734-1 1-139-51827-5 0-511-84644-4 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Introduction to healthcare ethics committees / D. Micah Hester and Toby Schonfeld -- Brief introduction to ethics and ethical theory / D. Micah Hester and Toby Schonfeld -- Ethics committees and the law / Stephen Latham -- Cultural and religious issues in healthcare / Alissa Hurwitz Swota -- Mission, vision, goals : defining the parameters of ethics consultation / Martin L. Smith -- Ethics consultation process / Jeffrey Spike -- Informed consent, shared decision-making, and the ethics committee / Randall Horton and Howard Brody -- Decision-making capacity / Arthur R. Derse -- Family dynamics and surrogate decision-making / Lisa Soleymani Lehmann -- Confidentiality / Toby Schonfeld -- Advance care planning and end-of-life decision-making / Nancy M.P. King and John C. Moskop -- Medical futility / Taddeus Mason Pope -- Issues in reproduction / Anne Drapkin Lyerly -- Ethical issues in neonatology / John D. Lantos -- Ethical issues in pediatrics / D. Micah Hester -- Ethics committees and distributive justice / Nancy S. Jecker -- Developing effective ethics policy / Anne Lederman Flamm -- Implementing policy to the wider community / Mary Faith Marshall and Joan Liaschenko -- Ethics in and for the organization / Mary V. Rorty -- The healthcare ethics committee as educator / Kathy Kinlaw -- Education as prevention / Kayhan Parsi -- Understanding ethics pedagogy / Felicia Cohn. |
Record Nr. | UNINA-9910465414303321 |
Cambridge : , : Cambridge University Press, , 2012 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Guidance for healthcare ethics committees / / edited by D. Micah Hester, Toby Schonfeld [[electronic resource]] |
Pubbl/distr/stampa | Cambridge : , : Cambridge University Press, , 2012 |
Descrizione fisica | 1 online resource (xiii, 185 pages) : digital, PDF file(s) |
Disciplina | 174.2 |
Soggetto topico |
Medical ethics committees
Medical ethics |
ISBN |
1-139-50780-X
1-107-22395-4 9786613684646 1-139-51477-6 1-139-51642-6 1-139-51384-2 1-280-77387-1 1-139-51734-1 1-139-51827-5 0-511-84644-4 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Introduction to healthcare ethics committees / D. Micah Hester and Toby Schonfeld -- Brief introduction to ethics and ethical theory / D. Micah Hester and Toby Schonfeld -- Ethics committees and the law / Stephen Latham -- Cultural and religious issues in healthcare / Alissa Hurwitz Swota -- Mission, vision, goals : defining the parameters of ethics consultation / Martin L. Smith -- Ethics consultation process / Jeffrey Spike -- Informed consent, shared decision-making, and the ethics committee / Randall Horton and Howard Brody -- Decision-making capacity / Arthur R. Derse -- Family dynamics and surrogate decision-making / Lisa Soleymani Lehmann -- Confidentiality / Toby Schonfeld -- Advance care planning and end-of-life decision-making / Nancy M.P. King and John C. Moskop -- Medical futility / Taddeus Mason Pope -- Issues in reproduction / Anne Drapkin Lyerly -- Ethical issues in neonatology / John D. Lantos -- Ethical issues in pediatrics / D. Micah Hester -- Ethics committees and distributive justice / Nancy S. Jecker -- Developing effective ethics policy / Anne Lederman Flamm -- Implementing policy to the wider community / Mary Faith Marshall and Joan Liaschenko -- Ethics in and for the organization / Mary V. Rorty -- The healthcare ethics committee as educator / Kathy Kinlaw -- Education as prevention / Kayhan Parsi -- Understanding ethics pedagogy / Felicia Cohn. |
Record Nr. | UNINA-9910791901803321 |
Cambridge : , : Cambridge University Press, , 2012 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Guidance for healthcare ethics committees / / edited by D. Micah Hester, Toby Schonfeld [[electronic resource]] |
Pubbl/distr/stampa | Cambridge : , : Cambridge University Press, , 2012 |
Descrizione fisica | 1 online resource (xiii, 185 pages) : digital, PDF file(s) |
Disciplina | 174.2 |
Soggetto topico |
Medical ethics committees
Medical ethics |
ISBN |
1-139-50780-X
1-107-22395-4 9786613684646 1-139-51477-6 1-139-51642-6 1-139-51384-2 1-280-77387-1 1-139-51734-1 1-139-51827-5 0-511-84644-4 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Introduction to healthcare ethics committees / D. Micah Hester and Toby Schonfeld -- Brief introduction to ethics and ethical theory / D. Micah Hester and Toby Schonfeld -- Ethics committees and the law / Stephen Latham -- Cultural and religious issues in healthcare / Alissa Hurwitz Swota -- Mission, vision, goals : defining the parameters of ethics consultation / Martin L. Smith -- Ethics consultation process / Jeffrey Spike -- Informed consent, shared decision-making, and the ethics committee / Randall Horton and Howard Brody -- Decision-making capacity / Arthur R. Derse -- Family dynamics and surrogate decision-making / Lisa Soleymani Lehmann -- Confidentiality / Toby Schonfeld -- Advance care planning and end-of-life decision-making / Nancy M.P. King and John C. Moskop -- Medical futility / Taddeus Mason Pope -- Issues in reproduction / Anne Drapkin Lyerly -- Ethical issues in neonatology / John D. Lantos -- Ethical issues in pediatrics / D. Micah Hester -- Ethics committees and distributive justice / Nancy S. Jecker -- Developing effective ethics policy / Anne Lederman Flamm -- Implementing policy to the wider community / Mary Faith Marshall and Joan Liaschenko -- Ethics in and for the organization / Mary V. Rorty -- The healthcare ethics committee as educator / Kathy Kinlaw -- Education as prevention / Kayhan Parsi -- Understanding ethics pedagogy / Felicia Cohn. |
Record Nr. | UNINA-9910817301803321 |
Cambridge : , : Cambridge University Press, , 2012 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Handbook for health care ethics committees / / Linda Farber Post and Jeffrey Blustein |
Autore | Post Linda Farber |
Edizione | [Second edition.] |
Pubbl/distr/stampa | Baltimore, Maryland : , : Johns Hopkins University Press, , 2015 |
Descrizione fisica | 1 online resource (431 p.) |
Disciplina | 610 |
Soggetto topico | Medical ethics committees |
Soggetto genere / forma | Electronic books. |
ISBN | 1-4214-1658-1 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Ethical foundations of clinical practice -- Decision making and decisional capacity in adults -- Informed consent and refusal -- Truth telling : disclosure, privacy, and confidentiality -- Special decision-making concerns of minors -- Ethical issues in reproduction -- Special decision-making concerns of the elderly -- Ethical issues in the care of disabled persons -- End of life issues -- Palliation -- Justice, health, and access to health care -- Organizational ethics -- Profile of ethics committees -- Clinical ethics consultation -- Ethics education -- Sample clinical cases with ethics analyses -- Sample policies and procedures. |
Record Nr. | UNINA-9910460902303321 |
Post Linda Farber | ||
Baltimore, Maryland : , : Johns Hopkins University Press, , 2015 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Handbook for health care ethics committees / / Linda Farber Post and Jeffrey Blustein |
Autore | Post Linda Farber |
Edizione | [Second edition.] |
Pubbl/distr/stampa | Baltimore, Maryland : , : Johns Hopkins University Press, , 2015 |
Descrizione fisica | 1 online resource (431 p.) |
Disciplina | 610 |
Soggetto topico | Medical ethics committees |
Soggetto genere / forma | Electronic books. |
ISBN | 1-4214-1658-1 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Ethical foundations of clinical practice -- Decision making and decisional capacity in adults -- Informed consent and refusal -- Truth telling : disclosure, privacy, and confidentiality -- Special decision-making concerns of minors -- Ethical issues in reproduction -- Special decision-making concerns of the elderly -- Ethical issues in the care of disabled persons -- End of life issues -- Palliation -- Justice, health, and access to health care -- Organizational ethics -- Profile of ethics committees -- Clinical ethics consultation -- Ethics education -- Sample clinical cases with ethics analyses -- Sample policies and procedures. |
Record Nr. | UNINA-9910543429703321 |
Post Linda Farber | ||
Baltimore, Maryland : , : Johns Hopkins University Press, , 2015 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
The Nurse's healthcare ethics committee handbook : Use of leadership, advocacy, and empowerment to develop a nurse-led ethics committee / | / Angeline Dewey, Andrea Holecek |
Autore | Dewey Angeline |
Pubbl/distr/stampa | Indianapolis : , : Sigma, PPHU, Banecki, J., Jasniewski, I. i wspolnicy, spolka jawna, , 2018 |
Descrizione fisica | 1 online resource (193 pages) |
Disciplina | 174.2/9073 |
Altri autori (Persone) | HolecekAndrea |
Soggetto topico |
Nursing ethics
Medical ethics committees Leadership |
ISBN | 1-945157-57-7 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Ethical theories -- Healthcare ethics -- Modern healthcare ethics : landmark events that shaped hospital ethics protocols -- A nurse-led ethics committee -- Common ethical challenges -- Ethics case studies. |
Altri titoli varianti | Nurse's healthcare ethics committee handbook |
Record Nr. | UNINA-9910793596703321 |
Dewey Angeline | ||
Indianapolis : , : Sigma, PPHU, Banecki, J., Jasniewski, I. i wspolnicy, spolka jawna, , 2018 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
The Nurse's healthcare ethics committee handbook : Use of leadership, advocacy, and empowerment to develop a nurse-led ethics committee / | / Angeline Dewey, Andrea Holecek |
Autore | Dewey Angeline |
Pubbl/distr/stampa | Indianapolis : , : Sigma, PPHU, Banecki, J., Jasniewski, I. i wspolnicy, spolka jawna, , 2018 |
Descrizione fisica | 1 online resource (193 pages) |
Disciplina | 174.2/9073 |
Altri autori (Persone) | HolecekAndrea |
Soggetto topico |
Nursing ethics
Medical ethics committees Leadership |
ISBN | 1-945157-57-7 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Ethical theories -- Healthcare ethics -- Modern healthcare ethics : landmark events that shaped hospital ethics protocols -- A nurse-led ethics committee -- Common ethical challenges -- Ethics case studies. |
Altri titoli varianti | Nurse's healthcare ethics committee handbook |
Record Nr. | UNINA-9910815563103321 |
Dewey Angeline | ||
Indianapolis : , : Sigma, PPHU, Banecki, J., Jasniewski, I. i wspolnicy, spolka jawna, , 2018 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|