Salah M. Abd-el-Aleem
Medical Device Clinical Trials
Salah M. Abd-el-Aleem
Medical Device Clinical Trials
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Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate steps to take.…mehr
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Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate steps to take.
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Produktdetails
- Produktdetails
- Verlag: Wiley & Sons
- Artikelnr. des Verlages: 14560225000
- 1. Auflage
- Seitenzahl: 272
- Erscheinungstermin: 9. August 2010
- Englisch
- Abmessung: 240mm x 161mm x 19mm
- Gewicht: 548g
- ISBN-13: 9780470602256
- ISBN-10: 0470602252
- Artikelnr.: 29337363
- Verlag: Wiley & Sons
- Artikelnr. des Verlages: 14560225000
- 1. Auflage
- Seitenzahl: 272
- Erscheinungstermin: 9. August 2010
- Englisch
- Abmessung: 240mm x 161mm x 19mm
- Gewicht: 548g
- ISBN-13: 9780470602256
- ISBN-10: 0470602252
- Artikelnr.: 29337363
SALAH M. ABDEL-ALEEM, PhD, is Senior Manager of Clinical Operations at Proteus Biomedical, Inc., a medical device and pharmaceutical company that develops therapies for cardiovascular and diabetic diseases.¿He has over twenty years of experience in academic and corporate settings and has performed clinical research tasks and activities, such as the development of clinical standard operating procedures, clinical protocols, case report forms, clinical study forms, and investigator brochures for various academic and corporate settings. Dr. Abdel-aleem is the author of Design, Execution, and Management of Medical Device Clinical Trials, also published by Wiley.
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
Outcomes. Selection 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 Trials.
Subgroup 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 Report. Adverse
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 Controls. LACI 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". Determination of Nonsignificant Risk
Devices (NSR). Similarities and Differences between Medical Device and Drug
Regulations in Clinical Trials. Definitions of Drugs and Devices.
Combination Products. FDA-Sponsor Meetings. BIMO Inspection.
Investigator-Initiated Clinical Trials. 6. Challenges of Global Clinical
Studies and the CE Mark Process. Global Trial Considerations. Global
Harmonization Task Force Challenges. FDA Recommendations on Acceptance of
Foreign Clinical Sites. Operational Tips on Conductance of Global Clinical
Trials. CE Mark Process and Challenges. International Standard ISO 14155.
Differences between FDA and CE Mark Clinical Trials. Challenges to CE Mark
Studies. 7. Challenging FDA PMA Cases. PMA P970029 (TMR 2000 Holmium Laser
System). PMA P040012 Carotid Stenting for Treating Carotid Disease.
Historic Control Assumptions. Use of Angiographic Late Loss as Primary
Endpoint in Drug-Eluting Stent PMA P070015 (Xience V DES). 8. Bioethics in
Clinical Research. Bioethical Challenges in Clinical Studies. Good Clinical
Practice for the Investigator. WHO Principles of GCP. Guidelines and
Ethical Principles. IRB Review Process. Glossary of Clinical, CE Mark, and
Statistical Terms. References. Index.
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
Outcomes. Selection 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 Trials.
Subgroup 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 Report. Adverse
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 Controls. LACI 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". Determination of Nonsignificant Risk
Devices (NSR). Similarities and Differences between Medical Device and Drug
Regulations in Clinical Trials. Definitions of Drugs and Devices.
Combination Products. FDA-Sponsor Meetings. BIMO Inspection.
Investigator-Initiated Clinical Trials. 6. Challenges of Global Clinical
Studies and the CE Mark Process. Global Trial Considerations. Global
Harmonization Task Force Challenges. FDA Recommendations on Acceptance of
Foreign Clinical Sites. Operational Tips on Conductance of Global Clinical
Trials. CE Mark Process and Challenges. International Standard ISO 14155.
Differences between FDA and CE Mark Clinical Trials. Challenges to CE Mark
Studies. 7. Challenging FDA PMA Cases. PMA P970029 (TMR 2000 Holmium Laser
System). PMA P040012 Carotid Stenting for Treating Carotid Disease.
Historic Control Assumptions. Use of Angiographic Late Loss as Primary
Endpoint in Drug-Eluting Stent PMA P070015 (Xience V DES). 8. Bioethics in
Clinical Research. Bioethical Challenges in Clinical Studies. Good Clinical
Practice for the Investigator. WHO Principles of GCP. Guidelines and
Ethical Principles. IRB Review Process. Glossary of Clinical, CE Mark, and
Statistical Terms. References. Index.
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
Outcomes. Selection 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 Trials.
Subgroup 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 Report. Adverse
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 Controls. LACI 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". Determination of Nonsignificant Risk
Devices (NSR). Similarities and Differences between Medical Device and Drug
Regulations in Clinical Trials. Definitions of Drugs and Devices.
Combination Products. FDA-Sponsor Meetings. BIMO Inspection.
Investigator-Initiated Clinical Trials. 6. Challenges of Global Clinical
Studies and the CE Mark Process. Global Trial Considerations. Global
Harmonization Task Force Challenges. FDA Recommendations on Acceptance of
Foreign Clinical Sites. Operational Tips on Conductance of Global Clinical
Trials. CE Mark Process and Challenges. International Standard ISO 14155.
Differences between FDA and CE Mark Clinical Trials. Challenges to CE Mark
Studies. 7. Challenging FDA PMA Cases. PMA P970029 (TMR 2000 Holmium Laser
System). PMA P040012 Carotid Stenting for Treating Carotid Disease.
Historic Control Assumptions. Use of Angiographic Late Loss as Primary
Endpoint in Drug-Eluting Stent PMA P070015 (Xience V DES). 8. Bioethics in
Clinical Research. Bioethical Challenges in Clinical Studies. Good Clinical
Practice for the Investigator. WHO Principles of GCP. Guidelines and
Ethical Principles. IRB Review Process. Glossary of Clinical, CE Mark, and
Statistical Terms. References. Index.
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
Outcomes. Selection 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 Trials.
Subgroup 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 Report. Adverse
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 Controls. LACI 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". Determination of Nonsignificant Risk
Devices (NSR). Similarities and Differences between Medical Device and Drug
Regulations in Clinical Trials. Definitions of Drugs and Devices.
Combination Products. FDA-Sponsor Meetings. BIMO Inspection.
Investigator-Initiated Clinical Trials. 6. Challenges of Global Clinical
Studies and the CE Mark Process. Global Trial Considerations. Global
Harmonization Task Force Challenges. FDA Recommendations on Acceptance of
Foreign Clinical Sites. Operational Tips on Conductance of Global Clinical
Trials. CE Mark Process and Challenges. International Standard ISO 14155.
Differences between FDA and CE Mark Clinical Trials. Challenges to CE Mark
Studies. 7. Challenging FDA PMA Cases. PMA P970029 (TMR 2000 Holmium Laser
System). PMA P040012 Carotid Stenting for Treating Carotid Disease.
Historic Control Assumptions. Use of Angiographic Late Loss as Primary
Endpoint in Drug-Eluting Stent PMA P070015 (Xience V DES). 8. Bioethics in
Clinical Research. Bioethical Challenges in Clinical Studies. Good Clinical
Practice for the Investigator. WHO Principles of GCP. Guidelines and
Ethical Principles. IRB Review Process. Glossary of Clinical, CE Mark, and
Statistical Terms. References. Index.