Details

<p>List of Abbreviations xi</p> <p>Preface xv</p> <p>Acknowledgments xxi</p> <p><b>1 An Overview of Clinical Study Tasks and Activities 1</b></p> <p>Key Clinical Study Tasks and Activities 2</p> <p>Discussion of Key Tasks and Activities 3</p> <p>Management of Key Clinical Tasks and Activities 9</p> <p>Example of the Spread Sheet for Managing Clinical Study Activities 10</p> <p>The Clinical Research Team 10</p> <p><b>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 15</b></p> <p>Clinical Protocol 17</p> <p>Case Report Forms (CRFs) 28</p> <p>Example of the Case Report Form Template 32</p> <p>Informed Consent Form (ICF) 35</p> <p>Instructions for Use of Device 38</p> <p>Study Regulatory Binder 39</p> <p>Study Research Agreement 40</p> <p>Research Agreement Template 43</p> <p>Research Contract Challenges 50</p> <p>Clinical Forms and Certificates 51</p> <p>Clinical Standard Operating Procedures (SOPs) 54</p> <p><b>3 Qualification/Selection of Study Investigators and Study Monitoring Visits 63</b></p> <p>Qualification and Selection of Investigators 64</p> <p>Monitoring Visits 67</p> <p>Monitoring Reports 73</p> <p>Interim Monitoring Visit Report Template 75</p> <p><b>4 Adverse Events Definitions and Reporting Procedures 81</b></p> <p>Adverse Event Definitions 83</p> <p>Policies, Regulations, and Guidelines Regarding Adverse Event Reporting 84</p> <p>Adverse Event Reporting Pathway 84</p> <p>Terms for Causality Assessment 85</p> <p>GAPS/Challenges in Adverse Event Reporting 86</p> <p>Adverse Event Reporting Time Periods (21 CFR 803) 88</p> <p>Differences between the United States and Europe in Reporting Adverse Events 88</p> <p>Serious Adverse Event Narratives 89</p> <p>Classification of Adverse Events 90</p> <p>Special Requirement for Reporting Certain Adverse Events 92</p> <p>Case Example 92</p> <p>Mandatory Device Reporting for FDA-Approved Devices 92</p> <p><b>5 Statistical Analysis Plan (SAP) and Biostatistics in Clinical Research 93</b></p> <p>Statistical Analysis Plan (SAP) 94</p> <p>Selection of Study Endpoints 97</p> <p>Biostatistics in Clinical Research 101</p> <p><b>6 Final Clinical Study Report 113</b></p> <p>Final Clinical Report’s Outline 114</p> <p>Discussion of Sections in the Final Clinical Report 116</p> <p><b>7 Medical Device Regulations Combination Product, Study Committees, and FDA-Sponsor Meetings 127</b></p> <p>Medical Device Regulations 129</p> <p>Combination Products 164</p> <p>Study Committees 168</p> <p>FDA-Sponsor Meetings 170</p> <p>Registration of Clinical Trials 174</p> <p>Implementation of the HIPAA Privacy Rule in Clinical Research 175</p> <p>Institutional Review Boards (IRB) 180</p> <p>FDA’s Oversight of Clinical Trials (Bioresearch Monitoring) 191</p> <p>Code of Federal Regulations of Medical Devices 194</p> <p><b>8 Design Issues in Medical Devices Studies 195</b></p> <p>Design of the Clinical Trial 196</p> <p>Assumptions and Parameters of Clinical Trial Design 196</p> <p>Clinical Trials’ Design Issues and Data Analysis Issues 202</p> <p>Use of Historic Controls as the Control Group in IDE Studies 206</p> <p>Summary of Recommendations When Using Historic Controls 218</p> <p><b>9 Investigator-Initiated Clinical Research 221</b></p> <p>Definition and Examples of Investigator-Initiated Clinical Research 222</p> <p>Development, Conduct, and Management of Investigator-Initiated Clinical Research 224</p> <p>Regulation of Investigator-Initiated Clinical Research 225</p> <p>Required Infrastructure for Investigator-Initiated Clinical Research 226</p> <p>Clinical Research Sponsored by NIH 227</p> <p><b>10 Ethical Conduct for Human Research 229</b></p> <p>The Nuremberg Code (1947) 230</p> <p>World Medical Association—Declaration of Helsinki (1964–Present) 231</p> <p>National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974) 231</p> <p>The Belmont Report (1978) 232</p> <p>Special Ethical Concerns in Clinical Research on Use of Placebo 232</p> <p>Glossary of Clinical Trial and Statistical Terms 235</p> <p>References 249</p> <p>Index 255</p>

<p><b>SALAH M. ABDEL-ALEEM, P<small>H</small>D,</b> 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.

<p><b>AN ESSENTIAL INTRODUCTION TO CONDUCTING THE VARIOUS STAGES OF MEDICAL DEVICE CLINICAL TRIALS</b> <p>Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. <p>Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: <ul> <li>Qualification and selection of investigators</li> <li>Study monitoring visits</li> <li>Definitions and reporting procedures for adverse events</li> <li>The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints</li> <li>The roles and responsibilities of all members of a clinical research team</li> </ul> <p>The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. <p>Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.

US