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Biblioteca

MARC Lista (tabellare)
Current controlled trials in cardiovascular medicine / / BioMed Central, PubMed Central
Current controlled trials in cardiovascular medicine / / BioMed Central, PubMed Central
Pubbl/distr/stampa [London], : BioMed Central, 2000-2005
Descrizione fisica 1 online resource
Disciplina 616
Soggetto topico Cardiology
Clinical trials
Cardiovascular Diseases - therapy
Cardiovascular Diseases - physiopathology
Soggetto genere / forma Periodicals.
Controlled Clinical Trial
Soggetto non controllato Cardiovascular Diseases
ISSN 1468-6694
Formato Materiale a stampa
Livello bibliografico Periodico
Lingua di pubblicazione eng
Nota di contenuto Hypothesis to explain poor outcomes in the ALLHAT and V-HeFT trials: decreased expression of heat shock proteins -- Comments on ALLHAT and doxazosin -- Benefits and side effects of blood pressure lowering treatment: what was wrong with doxazosin in the ALLHAT? -- Debate: PCI or CABG for multivessel disease? Viewpoint: No clear winner in an unfair fight -- Debate: PCI vs CABG: a moving target, but we are gaining -- Debate: Should statin be used in patients with heart failure? -- Debate: Statins should be used in patients with heart failure -- Cytokines as new treatment targets in chronic heart failure -- Therapeutic angiogenesis for cardiovascular disease -- Distal protection devices during percutaneous coronary and carotid interventions -- Biventricular pacing in heart failure: update on results from clinical trials -- How well can blood pressure be controlled? Progress report on the Systolic Hypertension in Europe Follow-Up Study (Syst-Eur 2) -- A new era in hypertension research: discussing the findings of ALLHAT.
Altri titoli varianti CCTCVM
Record Nr. UNISA-996204820603316
[London], : BioMed Central, 2000-2005
Materiale a stampa
Lo trovi qui: Univ. di Salerno
Opac: Controlla la disponibilità qui
Current controlled trials in cardiovascular medicine / / BioMed Central, PubMed Central
Current controlled trials in cardiovascular medicine / / BioMed Central, PubMed Central
Pubbl/distr/stampa [London], : BioMed Central, 2000-2005
Descrizione fisica 1 online resource
Disciplina 616
Soggetto topico Cardiology
Clinical trials
Cardiovascular Diseases - therapy
Cardiovascular Diseases - physiopathology
Soggetto genere / forma Periodicals.
Controlled Clinical Trial
Soggetto non controllato Cardiovascular Diseases
ISSN 1468-6694
Formato Materiale a stampa
Livello bibliografico Periodico
Lingua di pubblicazione eng
Nota di contenuto Hypothesis to explain poor outcomes in the ALLHAT and V-HeFT trials: decreased expression of heat shock proteins -- Comments on ALLHAT and doxazosin -- Benefits and side effects of blood pressure lowering treatment: what was wrong with doxazosin in the ALLHAT? -- Debate: PCI or CABG for multivessel disease? Viewpoint: No clear winner in an unfair fight -- Debate: PCI vs CABG: a moving target, but we are gaining -- Debate: Should statin be used in patients with heart failure? -- Debate: Statins should be used in patients with heart failure -- Cytokines as new treatment targets in chronic heart failure -- Therapeutic angiogenesis for cardiovascular disease -- Distal protection devices during percutaneous coronary and carotid interventions -- Biventricular pacing in heart failure: update on results from clinical trials -- How well can blood pressure be controlled? Progress report on the Systolic Hypertension in Europe Follow-Up Study (Syst-Eur 2) -- A new era in hypertension research: discussing the findings of ALLHAT.
Altri titoli varianti CCTCVM
Record Nr. UNINA-9910134113603321
[London], : BioMed Central, 2000-2005
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 [[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
Opac: Controlla la disponibilità qui
The design and management of medical device clinical trials [[electronic resource] ] : strategies and challenges / / Salah Abdel-aleem
The design and management of medical device clinical trials [[electronic resource] ] : strategies and challenges / / Salah Abdel-aleem
Autore Abdel-aleem Salah
Pubbl/distr/stampa Hoboken, N.J., : Wiley, c2010
Descrizione fisica 1 online resource (269 p.)
Disciplina 610.28
610.28/4072
Soggetto topico Clinical trials
Medical instruments and apparatus - Research
ISBN 1-283-27396-9
9786613273963
1-118-12545-2
1-118-16461-X
1-118-16462-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto The Design and Management of Medical Device Clinical Trials: Strategies and Challenges; Contents; List of Abbreviations; Preface; Acknowledgments; 1. Challenges to the Design of Clinical Study; Development of Clinical SOPs; Selection of Study Patients, Investigators, and Study Sites; Definition of Enrolled Subjects in a Clinical Study; Definition of the Investigational Device System; Research Contract Challenges; Review of Literature; Challenges to the Design of the Study Protocol, Statistical Analysis Plan (SAP), and Selection of Study Endpoints; Masking or Blinding
Primary and Secondary OutcomesSelection of Study Endpoints; Differences between the Primary Endpoint in FDA and CE Mark Studies; SAP and Study Endpoints; Components of the SAP for Clinical Trials; Roles and Responsibilities of the Clinical Personnel in Completing the Study Protocol; Changing the Primary Outcome during the Conduct of the Study; Definition of Primary and Secondary Endpoints; Combined ""Composite"" Endpoints; Surrogate Endpoints; Reducing the Study's Sample Size; Statistical Terms to Define Endpoint Measurements; Reporting Results of Clinical Trials
Superiority and Equivalence TrialsSubgroup Analysis; Challenges to ICF; Risk/Benefit Analysis; 2. Challenges to Managing the Study; Enhancing Patient Enrollment by Relaxation of Study Criteria; Compliance with the Study Protocol; Challenges Associated with Data Accuracy and Completeness; Data Analysis; Data Integrity; Criteria for Using Meta-Analysis Studies; Who Should have Access to Clinical Trial Records; Managing Study Data and Quality Assurance; Missing Data Analysis; Examination of Data across Study Sites; Challenges to Adverse Event Reporting; Adverse Event Coding Systems
Protocol Deviation ReportAdverse Event Reporting in Final Study Clinical Report; Difference between the US and EU Definitions and Reporting of Adverse Events; Adverse Event Reporting Challenges; Minimization of Bias in Clinical Trials; 3. Selection of Historic Controls; Types of Control Group in Medical Device Clinical Trials; Purpose of Control Group; Use of Placebo Control; Advantages of Randomized Control Clinical Trials; Disadvantages of Randomized Control Clinical Trials; Commonly Used Pivotal Designs; Definition of Historic Control; Objective Performance Criteria (OPC)
Examples of Clinical Studies with Historic ControlsLACI Clinical Study; Left Ventricular Assist Devices; Summary of Clinical Studies; Summary of Recommendations for Historic Control; 4. Fraud and Misconduct in Clinical Trials; Fraud and Misconduct in Clinical Trials; Warning Signs of Fraud; Tips for Detecting Serious Misconduct; False Claims Act; Fraud Prevention; Policy on Handling Complaints of Misconduct; Reporting Research Misconduct; Bioresearch Monitoring Information System (BMIS); 5. Challenges to the Regulation of Medical Device; Determination of 510(K) Devices
510(K) ""Substantial Equivalence Decision Making Process""
Record Nr. UNINA-9910139590703321
Abdel-aleem Salah  
Hoboken, N.J., : Wiley, c2010
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
The design and management of medical device clinical trials [[electronic resource] ] : strategies and challenges / / Salah Abdel-aleem
The design and management of medical device clinical trials [[electronic resource] ] : strategies and challenges / / Salah Abdel-aleem
Autore Abdel-aleem Salah
Pubbl/distr/stampa Hoboken, N.J., : Wiley, c2010
Descrizione fisica 1 online resource (269 p.)
Disciplina 610.28
610.28/4072
Soggetto topico Clinical trials
Medical instruments and apparatus - Research
ISBN 1-283-27396-9
9786613273963
1-118-12545-2
1-118-16461-X
1-118-16462-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto The Design and Management of Medical Device Clinical Trials: Strategies and Challenges; Contents; List of Abbreviations; Preface; Acknowledgments; 1. Challenges to the Design of Clinical Study; Development of Clinical SOPs; Selection of Study Patients, Investigators, and Study Sites; Definition of Enrolled Subjects in a Clinical Study; Definition of the Investigational Device System; Research Contract Challenges; Review of Literature; Challenges to the Design of the Study Protocol, Statistical Analysis Plan (SAP), and Selection of Study Endpoints; Masking or Blinding
Primary and Secondary OutcomesSelection of Study Endpoints; Differences between the Primary Endpoint in FDA and CE Mark Studies; SAP and Study Endpoints; Components of the SAP for Clinical Trials; Roles and Responsibilities of the Clinical Personnel in Completing the Study Protocol; Changing the Primary Outcome during the Conduct of the Study; Definition of Primary and Secondary Endpoints; Combined ""Composite"" Endpoints; Surrogate Endpoints; Reducing the Study's Sample Size; Statistical Terms to Define Endpoint Measurements; Reporting Results of Clinical Trials
Superiority and Equivalence TrialsSubgroup Analysis; Challenges to ICF; Risk/Benefit Analysis; 2. Challenges to Managing the Study; Enhancing Patient Enrollment by Relaxation of Study Criteria; Compliance with the Study Protocol; Challenges Associated with Data Accuracy and Completeness; Data Analysis; Data Integrity; Criteria for Using Meta-Analysis Studies; Who Should have Access to Clinical Trial Records; Managing Study Data and Quality Assurance; Missing Data Analysis; Examination of Data across Study Sites; Challenges to Adverse Event Reporting; Adverse Event Coding Systems
Protocol Deviation ReportAdverse Event Reporting in Final Study Clinical Report; Difference between the US and EU Definitions and Reporting of Adverse Events; Adverse Event Reporting Challenges; Minimization of Bias in Clinical Trials; 3. Selection of Historic Controls; Types of Control Group in Medical Device Clinical Trials; Purpose of Control Group; Use of Placebo Control; Advantages of Randomized Control Clinical Trials; Disadvantages of Randomized Control Clinical Trials; Commonly Used Pivotal Designs; Definition of Historic Control; Objective Performance Criteria (OPC)
Examples of Clinical Studies with Historic ControlsLACI Clinical Study; Left Ventricular Assist Devices; Summary of Clinical Studies; Summary of Recommendations for Historic Control; 4. Fraud and Misconduct in Clinical Trials; Fraud and Misconduct in Clinical Trials; Warning Signs of Fraud; Tips for Detecting Serious Misconduct; False Claims Act; Fraud Prevention; Policy on Handling Complaints of Misconduct; Reporting Research Misconduct; Bioresearch Monitoring Information System (BMIS); 5. Challenges to the Regulation of Medical Device; Determination of 510(K) Devices
510(K) ""Substantial Equivalence Decision Making Process""
Record Nr. UNINA-9910814185203321
Abdel-aleem Salah  
Hoboken, N.J., : Wiley, c2010
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Design, execution, and management of medical device clinical trials [[electronic resource] /] / Salah Abdel-aleem
Design, execution, and management of medical device clinical trials [[electronic resource] /] / Salah Abdel-aleem
Autore Abdel-aleem Salah
Pubbl/distr/stampa Hoboken, N.J., : John Wiley & Sons, c2009
Descrizione fisica 1 online resource (296 p.)
Disciplina 610.28/4
Soggetto topico Medical instruments and apparatus - Research
Clinical trials
ISBN 1-282-27905-X
9786612279058
0-470-47591-9
0-470-47590-0
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto DESIGN, EXECUTION, AND MANAGEMENT OF MEDICAL DEVICE CLINICAL TRIALS; CONTENTS; List of Abbreviations; Preface; Acknowledgments; 1 An Overview of Clinical Study Tasks and Activities; Key Clinical Study Tasks and Activities; Discussion of Key Tasks and Activities; Management of Key Clinical Tasks and Activities; Example of the Spread Sheet for Managing Clinical Study Activities; The Clinical Research Team
2 Development of Clinical Protocols, Case Report Forms, Clinical Standard Operating Procedures, Informed Consent Form, Study Regulatory Binder, Study Research Agreement, and Other Clinical Materials Clinical Protocol; Case Report Forms (CRFs); Example of the Case Report Form Template; Informed Consent Form (ICF); Instructions for Use of Device; Study Regulatory Binder; Study Research Agreement; Research Agreement Template; Research Contract Challenges; Clinical Forms and Certificates; Clinical Standard Operating Procedures (SOPs)
3 Qualification/Selection of Study Investigators and Study Monitoring Visits Qualification and Selection of Investigators; Monitoring Visits; Monitoring Reports; Interim Monitoring Visit Report Template; 4 Adverse Events Definitions and Reporting Procedures; Adverse Event Definitions; Policies, Regulations, and Guidelines Regarding Adverse Event Reporting; Adverse Event Reporting Pathway; Terms for Causality Assessment; GAPS/Challenges in Adverse Event Reporting; Adverse Event Reporting Time Periods (21 CFR 803); Differences between the United States and Europe in Reporting Adverse Events
Serious Adverse Event Narratives Classification of Adverse Events; Special Requirement for Reporting Certain Adverse Events; Case Example; Mandatory Device Reporting for FDA-Approved Devices; 5 Statistical Analysis Plan (SAP) and Biostatistics in Clinical Research; Statistical Analysis Plan (SAP); Selection of Study Endpoints; Biostatistics in Clinical Research; 6 Final Clinical Study Report; Final Clinical Report's Outline; Discussion of Sections in the Final Clinical Report; 7 Medical Device Regulations, Combination Product, Study Committees, and FDA-Sponsor Meetings
Medical Device Regulations Combination Products; Study Committees; FDA-Sponsor Meetings; Registration of Clinical Trials; Implementation of the HIPAA Privacy Rule in Clinical Research; Institutional Review Boards (IRB); FDA's Oversight of Clinical Trials (Bioresearch Monitoring); Code of Federal Regulations of Medical Devices; 8 Design Issues in Medical Devices Studies; Design of the Clinical Trial; Assumptions and Parameters of Clinical Trial Design; Clinical Trials' Design Issues and Data Analysis Issues; Use of Historic Controls as the Control Group in IDE Studies
Summary of Recommendations When Using Historic Controls
Record Nr. UNINA-9910139803003321
Abdel-aleem Salah  
Hoboken, N.J., : John Wiley & Sons, c2009
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui