The Design and Management of Medical Device Clinical Trials: Strategies and Challenges

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.

Spis treści:
List of Abbreviations.
Preface.
Acknowledgment.
1 CHALLENGES TO THE DESIGN OF CLINICAL STUDY.
Development of clinical SOPs.
Selection of study patient investigators and clinical sites.
Definition of enrolled subjects.
Definition of investigational device system.
Research contract challenges.
Review of literature.
Challenges to the design of the study protocol, study SAP, and selection of study endpoints Masking or blinding.
Difference between the primary endpoint in the FDA and CE mark studies.
Primary and secondary outcomes.
SAP and study endpoints.
Components of the SAP in clinical studies.
Roles and responsibilities of clinical personnel in completing the study protocol.
Changing the primary outcome during the conduct of the study.
Definition of the primary and secondary endpoints.
Composite endpoints.
Surrogate endpoints.
Sample size determination.
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.
Compliance with the study protocol.
Challenges associated with data accuracy and completeness.
Intent–to–treat ana lysis.
Per–protocol analysis.
Subgroup analysis.
Problems with subgroup analysis.
Criteria for using meta–analysis studies.
Managing study data and quality assurance.
Missing data analysis.
Examination of data across study sites.
Examples of early termination in clinical studies.
Challenges to adverse event reporting.
Differences between the US and EU in reporting adverse events.
Minimization of bias in clinical studies.
3 SELECTION OF HISTORIC CONTROLS.
Types of control group in clinical studies.
Purpose of control group.
Use of placebo control.
Advantages of randomized clinical trials.
Disadvantages of randomized clinical trials.
Commonly used pivotal design.
Definition of the historic controls.
Objective performance criteria (OPC).
Examples of clinical studies with historic controls.
LACI clinical study.
Left ventricular assist device Heartmate II left ventricular.
assist device and Cardiowest total artificial heart.
Summary of recommendations when using historic control.
4 FRAUD AND MISCONDUCT IN CLINICAL TRIALS.
Fraud and misconduct in clinical trials.
Warning signals of fraud.
Tips for detecting serious misconduct.
Fraud prevention.
Policy on complaints of misconduct.
Reporting research misconduct.
Bioresearch monitoring information system (BMIS).
5 CHALLENGES TO THE REGULATION OF MEDICAL DEVICE.
Determination 510 (k) devices.
510 (K) "Substantial equivalence decision making process".
Determination of non significant risk devices (NSR).
Similarities and differences between medical device and drugs in clinical trials.
Combination products.
FDA–sponsor meetings.
BIMO Inspection.
Recommendations for preparing the sponsor for the BIMO Inspection.
Investigator– initiated clinical trials.
6 CHALLENGES OF GLOBAL CLINICAL STUDIES AND THE CE MARK PROCESS.
Global trial considerations.< br>Global harmonization task force Challenges.
FDA recommendations regarding the acceptance of foreign clinical sites.
Operational tips on global clinical trials.
The CE mark process and its challenges.
International standard–ISO 14155.
Difference between the FDA and CE mark clinical trials.
Challenges to CE mark studies .
7 CHALLENGING FDA PMA CASES.
PMA P970029 (TMR 2000 holmium laser system).
PMA P030047 carotid stenting for treating carotid disease.
The use of angiographic late loss as the primary endpoint in drug eluting stent–PMA P070015 (Xience V DES).
8 BIOETHICS IN CLININCAL RESEARCH.
The principles of GCP guidance.
Good clinical practice (GCP).
WHO principles of GCP.
Guidelines of ethical principles.
IRB review process.
GLOSSARY OF CLINICAL, CE MARK, AND STATISTICAL TERMS.
REFERENCES.
INDEX.