Design, Execution, and Management of Medical Device Clinical Trials (eBook)

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. Dr. Abdel-aleem has over twenty years of clinical research experience in various academic and corporate settings.

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 Qualifi cation/Selection of Study Investigators and Study Monitoring Visits.

Qualifi cation and Selection of Investigators.

Monitoring Visits.

Monitoring Reports.

Interim Monitoring Visit Report Template.

4 Adverse Events Defi nitions 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.

Classifi cation 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.

9 Investigator-Initiated Clinical Research.

Defi nition and Examples of Investigator-Initiated Clinical Research.

Development, Conduct, and Management of Investigator-Initiated Clinical Research.

Regulation of Investigator-Initiated Clinical Research.

Required Infrastructure for Investigator-Initiated Clinical Research.

Clinical Research Sponsored by NIH.

10 Ethical Conduct for Human Research.

The Nuremberg Code (1947).

World Medical Association--Declaration of Helsinki (1964-Present).

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974).

The Belmont Report (1978).

Special Ethical Concerns in Clinical Research on Use of Placebo.

Glossary of Clinical Trial and Statistical Terms.

References.

Index.