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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 | ||
| ||
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 | ||
| ||
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 | ||
| ||
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-9910827440103321 |
|
Abdel-aleem Salah
|
||
| Hoboken, N.J., : John Wiley & Sons, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||