THE DESIGN AND MANAGEMENT OF MEDICAL DEVICE CLINICAL TRIALS STRATEGIES AND CHALLENGES. Salah Abdel-aleem WILEY A JOHN WILEY & SONS, INC.

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1 THE DESIGN AND MANAGEMENT OF MEDICAL DEVICE CLINICAL TRIALS STRATEGIES AND CHALLENGES Salah Abdel-aleem WILEY A JOHN WILEY & SONS, INC., PUBLICATION

2 CONTENTS List of Abbreviations Preface Acknowledgments xi xiii xvii 1. Challenges to the Design of Clinical Study 1 Development of Clinical SOPs 3 Selection of Study Patients, Investigators, and Study Sites 3 Definition of Enrolled Subjects in a Clinical Study 7 Definition of the Investigational Device System 7 Research Contract Challenges 7 Review of Literature 9 Challenges to the Design of the Study Protocol, Statistical Analysis Plan (SAP), and Selection of Study Endpoints 11 Masking or Blinding 12 Primary and Secondary Outcomes 14 Selection of Study Endpoints 14 Differences between the Primary Endpoint in FDA and CE Mark Studies 15 SAP and Study Endpoints 15 Components of the SAP for Clinical Trials 17 Roles and Responsibilities of the Clinical Personnel in Completing the Study Protocol 19 Changing the Primary Outcome during the Conduct of the Study 20 Definition of Primary and Secondary Endpoints 22 Combined "Composite" Endpoints 22 Surrogate Endpoints 23 Reducing the Study's Sample Size 25 Statistical Terms to Define Endpoint Measurements 25 Results of Clinical Trials 28 Reporting Superiority and Equivalence Trials 30 Subgroup Analysis 33 vii

3 Viii CONTENTS Challenges to ICF 35 Risk/Benefit Analysis Challenges to Managing the Study 43 Enhancing Patient Enrollment by Relaxation of Study Criteria 45 Compliance with the Study Protocol 46 Challenges Associated with Data Accuracy and Completeness 47 Data Analysis 49 Data Integrity 55 Criteria for Using Meta-Analysis Studies 56 Who Should have Access to Clinical Trial Records 57 Managing Study Data and Quality Assurance 58 Missing Data Analysis 59 Examination of Data across Study Sites 60 Challenges to Adverse Event Reporting 62 Adverse Event Coding Systems 66 Protocol Deviation Report 68 Adverse Event Reporting in Final Study Clinical Report 68 Difference between the US and EU Definitions and Reporting of Adverse Events 69 Adverse Event Reporting Challenges 69 Minimization of Bias in Clinical Trials Selection of Historic Controls 71 Types of Control Group in Medical Device Clinical Trials 73 Purpose of Control Group 73 Use of Placebo Control 74 Advantages of Randomized Control Clinical Trials 74 Disadvantages of Randomized Control Clinical Trials 74 Commonly Used Pivotal Designs 75 Definition of Historic Control 77 Objective Performance Criteria (OPC) 78 Examples of Clinical Studies with Historic Controls 80 LACI Clinical Study 80 Left Ventricular Assist Devices 86 Summary of Clinical Studies 88 Summary of Recommendations for Historic Control 96

4 CONTENTS ix 4. Fraud and Misconduct in Clinical Trials 99 Fraud and Misconduct in Clinical Trials 100 Warning Signs Tips for Detecting of Fraud 101 Serious Misconduct 102 False Claims Act 102 Fraud Prevention 103 Policy on Handling Complaints of Misconduct 103 Reporting Research Misconduct 104 Bioresearch Monitoring Information System (BMIS) Challenges to the Regulation of Medical Device 107 Determination of 510(K) Devices 108 Process" (K) "Substantial Equivalence Decision Making Determination of Nonsignificant Risk Devices (NSR) 111 Similarities and Differences between Medical Device and Drug Regulations in Clinical Trials 112 Definitions of Drugs and Devices 113 Combination Products 126 FDA-Sponsor Meetings 129 BIMO Inspection 130 Investigator-Initiated Clinical Trials Challenges of Global Clinical Studies and the CE Mark Process 137 Global Trial Considerations 138 Global Harmonization Task Force Challenges 142 FDA Recommendations on Acceptance of Foreign Clinical Sites 143 Operational Tips on Conductance of Global Clinical Trials 143 CE Mark Process and Challenges 146 International Standard ISO Differences between FDA and CE Mark Clinical Trials 157 Challenges 7. Challenging to CE Mark Studies 160 FDA PMA Cases 163 PMA P (TMR 2000 Holmium Laser System) 164 PMA P Carotid Stenting for Treating Carotid Disease 175 Historic Control Assumptions 175

5 X CONTENTS Use of Angiographic Late Loss as Primary Endpoint in Drug-Eluting Stent PMA P (Xience V DES) Bioethics in Clinical Research 199 Bioethical Challenges in Clinical Studies 200 Good Clinical Practice for the Investigator 201 WHO Principles of GCP 202 Guidelines and Ethical Principles 204 IRB Review Process 206 Glossary of Clinical, CE Mark, and Statistical Terms 211 References 217 Index 221

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