{"product_id":"the-design-and-management-of-medical-device-clinical-trials-isbn-9780470602256","title":"The Design and Management of Medical Device Clinical Trials","description":"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. \u003cp\u003eList of Abbreviations xi\u003c\/p\u003e \u003cp\u003ePreface xiii\u003c\/p\u003e \u003cp\u003eAcknowledgments xvii\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1. Challenges to the Design of Clinical Study 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDevelopment of Clinical SOPs 3\u003c\/p\u003e \u003cp\u003eSelection of Study Patients, Investigators, and Study Sites 3\u003c\/p\u003e \u003cp\u003eDefinition of Enrolled Subjects in a Clinical Study 7\u003c\/p\u003e \u003cp\u003eDefinition of the Investigational Device System 7\u003c\/p\u003e \u003cp\u003eResearch Contract Challenges 7\u003c\/p\u003e \u003cp\u003eReview of Literature 9\u003c\/p\u003e \u003cp\u003eChallenges to the Design of the Study Protocol, Statistical Analysis Plan (SAP), and Selection of Study Endpoints 11\u003c\/p\u003e \u003cp\u003eMasking or Blinding 12\u003c\/p\u003e \u003cp\u003ePrimary and Secondary Outcomes 14\u003c\/p\u003e \u003cp\u003eSelection of Study Endpoints 14\u003c\/p\u003e \u003cp\u003eDifferences between the Primary Endpoint in FDA and CE Mark Studies 15\u003c\/p\u003e \u003cp\u003eSAP and Study Endpoints 15\u003c\/p\u003e \u003cp\u003eComponents of the SAP for Clinical Trials 17\u003c\/p\u003e \u003cp\u003eRoles and Responsibilities of the Clinical Personnel in Completing the Study Protocol 19\u003c\/p\u003e \u003cp\u003eChanging the Primary Outcome during the Conduct of the Study 20\u003c\/p\u003e \u003cp\u003eDefinition of Primary and Secondary Endpoints 22\u003c\/p\u003e \u003cp\u003eCombined “Composite” Endpoints 22\u003c\/p\u003e \u003cp\u003eSurrogate Endpoints 23\u003c\/p\u003e \u003cp\u003eReducing the Study’s Sample Size 25\u003c\/p\u003e \u003cp\u003eStatistical Terms to Define Endpoint Measurements 25\u003c\/p\u003e \u003cp\u003eReporting Results of Clinical Trials 28\u003c\/p\u003e \u003cp\u003eSuperiority and Equivalence Trials 30\u003c\/p\u003e \u003cp\u003eSubgroup Analysis 33\u003c\/p\u003e \u003cp\u003eChallenges to ICF 35\u003c\/p\u003e \u003cp\u003eRisk\/Benefit Analysis 41\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2. Challenges to Managing the Study 43\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eEnhancing Patient Enrollment by Relaxation of Study Criteria 45\u003c\/p\u003e \u003cp\u003eCompliance with the Study Protocol 46\u003c\/p\u003e \u003cp\u003eChallenges Associated with Data Accuracy and Completeness 47\u003c\/p\u003e \u003cp\u003eData Analysis 49\u003c\/p\u003e \u003cp\u003eData Integrity 55\u003c\/p\u003e \u003cp\u003eCriteria for Using Meta-Analysis Studies 56\u003c\/p\u003e \u003cp\u003eWho Should have Access to Clinical Trial Records 57\u003c\/p\u003e \u003cp\u003eManaging Study Data and Quality Assurance 58\u003c\/p\u003e \u003cp\u003eMissing Data Analysis 59\u003c\/p\u003e \u003cp\u003eExamination of Data across Study Sites 60\u003c\/p\u003e \u003cp\u003eChallenges to Adverse Event Reporting 62\u003c\/p\u003e \u003cp\u003eAdverse Event Coding Systems 66\u003c\/p\u003e \u003cp\u003eProtocol Deviation Report 68\u003c\/p\u003e \u003cp\u003eAdverse Event Reporting in Final Study Clinical Report 68\u003c\/p\u003e \u003cp\u003eDifference between the US and EU Definitions and Reporting of Adverse Events 69\u003c\/p\u003e \u003cp\u003eAdverse Event Reporting Challenges 69\u003c\/p\u003e \u003cp\u003eMinimization of Bias in Clinical Trials 69\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3. Selection of Historic Controls 71\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eTypes of Control Group in Medical Device Clinical Trials 73\u003c\/p\u003e \u003cp\u003ePurpose of Control Group 73\u003c\/p\u003e \u003cp\u003eUse of Placebo Control 74\u003c\/p\u003e \u003cp\u003eAdvantages of Randomized Control Clinical Trials 74\u003c\/p\u003e \u003cp\u003eDisadvantages of Randomized Control Clinical Trials 74\u003c\/p\u003e \u003cp\u003eCommonly Used Pivotal Designs 75\u003c\/p\u003e \u003cp\u003eDefinition of Historic Control 77\u003c\/p\u003e \u003cp\u003eObjective Performance Criteria (OPC) 78\u003c\/p\u003e \u003cp\u003eExamples of Clinical Studies with Historic Controls 80\u003c\/p\u003e \u003cp\u003eLACI Clinical Study 80\u003c\/p\u003e \u003cp\u003eLeft Ventricular Assist Devices 86\u003c\/p\u003e \u003cp\u003eSummary of Clinical Studies 88\u003c\/p\u003e \u003cp\u003eSummary of Recommendations for Historic Control 96\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4. Fraud and Misconduct in Clinical Trials 99\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eFraud and Misconduct in Clinical Trials 100\u003c\/p\u003e \u003cp\u003eWarning Signs of Fraud 101\u003c\/p\u003e \u003cp\u003eTips for Detecting Serious Misconduct 102\u003c\/p\u003e \u003cp\u003eFalse Claims Act 102\u003c\/p\u003e \u003cp\u003eFraud Prevention 103\u003c\/p\u003e \u003cp\u003ePolicy on Handling Complaints of Misconduct 103\u003c\/p\u003e \u003cp\u003eReporting Research Misconduct 104\u003c\/p\u003e \u003cp\u003eBioresearch Monitoring Information System (BMIS) 104\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5. Challenges to the Regulation of Medical Device 107\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDetermination of 510(K) Devices 108\u003c\/p\u003e \u003cp\u003e510(K) “Substantial Equivalence Decision Making Process” 111\u003c\/p\u003e \u003cp\u003eDetermination of Nonsignificant Risk Devices (NSR) 111\u003c\/p\u003e \u003cp\u003eSimilarities and Differences between Medical Device and Drug Regulations in Clinical Trials 112\u003c\/p\u003e \u003cp\u003eDefinitions of Drugs and Devices 113\u003c\/p\u003e \u003cp\u003eCombination Products 126\u003c\/p\u003e \u003cp\u003eFDA–Sponsor Meetings 129\u003c\/p\u003e \u003cp\u003eBIMO Inspection 130\u003c\/p\u003e \u003cp\u003eInvestigator-Initiated Clinical Trials 132\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6. Challenges of Global Clinical Studies and the CE Mark Process 137\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eGlobal Trial Considerations 138\u003c\/p\u003e \u003cp\u003eGlobal Harmonization Task Force Challenges 142\u003c\/p\u003e \u003cp\u003eFDA Recommendations on Acceptance of Foreign Clinical Sites 143\u003c\/p\u003e \u003cp\u003eOperational Tips on Conductance of Global Clinical Trials 143\u003c\/p\u003e \u003cp\u003eCE Mark Process and Challenges 146\u003c\/p\u003e \u003cp\u003eInternational Standard ISO 14155 148\u003c\/p\u003e \u003cp\u003eDifferences between FDA and CE Mark Clinical Trials 157\u003c\/p\u003e \u003cp\u003eChallenges to CE Mark Studies 160\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7. Challenging FDA PMA Cases 163\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003ePMA P970029 (TMR 2000 Holmium Laser System) 164\u003c\/p\u003e \u003cp\u003ePMA P040012 Carotid Stenting for Treating Carotid Disease 175\u003c\/p\u003e \u003cp\u003eHistoric Control Assumptions 175\u003c\/p\u003e \u003cp\u003eUse of Angiographic Late Loss as Primary Endpoint in Drug-Eluting Stent PMA P070015 (Xience V DES) 186\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8. Bioethics in Clinical Research 199\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eBioethical Challenges in Clinical Studies 200\u003c\/p\u003e \u003cp\u003eGood Clinical Practice for the Investigator 201\u003c\/p\u003e \u003cp\u003eWHO Principles of GCP 202\u003c\/p\u003e \u003cp\u003eGuidelines and Ethical Principles 204\u003c\/p\u003e \u003cp\u003eIRB Review Process 206\u003c\/p\u003e \u003cp\u003eGlossary of Clinical, CE Mark, and Statistical Terms 211\u003c\/p\u003e \u003cp\u003eReferences 217\u003c\/p\u003e \u003cp\u003eIndex 221\u003c\/p\u003e \u003cb\u003eSALAH M. ABDEL-ALEEM, PhD,\u003c\/b\u003e 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 \u003ci\u003eDesign, Execution, and Management of Medical Device Clinical Trials\u003c\/i\u003e, also published by Wiley.  \u003cb\u003eAn in-depth and insightful presentation on dealing effectively with the challenges of clinical trials\u003c\/b\u003e  \u003cp\u003eClinical trials tasks and activities are widely diverse and require specific skill sets including excellent communication and management skills as well as the ability to develop different clinical scientific documents for successful planning and execution. \u003ci\u003eThe Design and Management of Medical Device Clinical Trials: Strategies and Challenges\u003c\/i\u003e provides readers with valuable information on overcoming obstacles in these three vital stages of clinical trials. Focusing primarily on medical device clinical trials, the author discusses common challenges, such as investigator and study site selection, slow study enrollment, study endpoint determination, handling compliance issues, missing data analysis, and protocol deviations.\u003c\/p\u003e \u003cp\u003eRather than delve too far into statistical theory, the book outlines only the essential quantitative methods that need to be understood when working hands-on with clinical trial data and research.¿Through practical examples, common issues that arise in the development and implementation of clinical trials are discussed including:\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eThe selection of historic controls over active control groups in clinical trials\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eChallenges to the regulations of medical devices, such as 510 K determination, determination of significant and non-significant risk devices, and similarities and differences of regulations between drugs and medical devices\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eWays to identify and avoid fraud and misconduct in clinical trials\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eObstacles encountered with the CE Mark process and global clinical trials\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eChallenges associated with high-profile FDA PMA cases where unconventional endpoints were used as the primary objectives of these studies\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003ci\u003eThe Design and Management of Medical Device Clinical Trials: Strategies and Challenges\u003c\/i\u003e is a valuable book for courses on biostatistics, epidemiology, and clinical research methods at the upper-undergraduate and graduate level. It is also an excellent reference for professionals in any area of clinical research who would like to learn more about working with medical device clinical trials and drug and biologics trials.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47990205317349,"sku":"NP9780470602256","price":124.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780470602256.jpg?v=1761786898","url":"https:\/\/k12savings.com\/es\/products\/the-design-and-management-of-medical-device-clinical-trials-isbn-9780470602256","provider":"K12savings","version":"1.0","type":"link"}