LEADER 05324nam 2200625Ia 450 001 9910814185203321 005 20230725053507.0 010 $a1-283-27396-9 010 $a9786613273963 010 $a1-118-12545-2 010 $a1-118-16461-X 010 $a1-118-16462-8 035 $a(CKB)2550000000054398 035 $a(EBL)700525 035 $a(OCoLC)751968804 035 $a(SSID)ssj0000554600 035 $a(PQKBManifestationID)11939861 035 $a(PQKBTitleCode)TC0000554600 035 $a(PQKBWorkID)10517207 035 $a(PQKB)11008611 035 $a(MiAaPQ)EBC700525 035 $a(EXLCZ)992550000000054398 100 $a20091104d2010 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 14$aThe design and management of medical device clinical trials$b[electronic resource] $estrategies and challenges /$fSalah Abdel-aleem 210 $aHoboken, N.J. $cWiley$dc2010 215 $a1 online resource (269 p.) 300 $aDescription based upon print version of record. 311 $a0-470-60225-2 320 $aIncludes bibliographical references and index. 327 $aThe Design and Management of Medical Device Clinical Trials: Strategies and Challenges; Contents; List of Abbreviations; Preface; Acknowledgments; 1. Challenges to the Design of Clinical Study; Development of Clinical SOPs; Selection of Study Patients, Investigators, and Study Sites; Definition of Enrolled Subjects in a Clinical Study; Definition of the Investigational Device System; Research Contract Challenges; Review of Literature; Challenges to the Design of the Study Protocol, Statistical Analysis Plan (SAP), and Selection of Study Endpoints; Masking or Blinding 327 $aPrimary and Secondary OutcomesSelection of Study Endpoints; Differences between the Primary Endpoint in FDA and CE Mark Studies; SAP and Study Endpoints; Components of the SAP for Clinical Trials; Roles and Responsibilities of the Clinical Personnel in Completing the Study Protocol; Changing the Primary Outcome during the Conduct of the Study; Definition of Primary and Secondary Endpoints; Combined ""Composite"" Endpoints; Surrogate Endpoints; Reducing the Study's Sample Size; Statistical Terms to Define Endpoint Measurements; Reporting Results of Clinical Trials 327 $aSuperiority and Equivalence TrialsSubgroup Analysis; Challenges to ICF; Risk/Benefit Analysis; 2. Challenges to Managing the Study; Enhancing Patient Enrollment by Relaxation of Study Criteria; Compliance with the Study Protocol; Challenges Associated with Data Accuracy and Completeness; Data Analysis; Data Integrity; Criteria for Using Meta-Analysis Studies; Who Should have Access to Clinical Trial Records; Managing Study Data and Quality Assurance; Missing Data Analysis; Examination of Data across Study Sites; Challenges to Adverse Event Reporting; Adverse Event Coding Systems 327 $aProtocol Deviation ReportAdverse Event Reporting in Final Study Clinical Report; Difference between the US and EU Definitions and Reporting of Adverse Events; Adverse Event Reporting Challenges; Minimization of Bias in Clinical Trials; 3. Selection of Historic Controls; Types of Control Group in Medical Device Clinical Trials; Purpose of Control Group; Use of Placebo Control; Advantages of Randomized Control Clinical Trials; Disadvantages of Randomized Control Clinical Trials; Commonly Used Pivotal Designs; Definition of Historic Control; Objective Performance Criteria (OPC) 327 $aExamples of Clinical Studies with Historic ControlsLACI Clinical Study; Left Ventricular Assist Devices; Summary of Clinical Studies; Summary of Recommendations for Historic Control; 4. Fraud and Misconduct in Clinical Trials; Fraud and Misconduct in Clinical Trials; Warning Signs of Fraud; Tips for Detecting Serious Misconduct; False Claims Act; Fraud Prevention; Policy on Handling Complaints of Misconduct; Reporting Research Misconduct; Bioresearch Monitoring Information System (BMIS); 5. Challenges to the Regulation of Medical Device; Determination of 510(K) Devices 327 $a510(K) ""Substantial Equivalence Decision Making Process"" 330 $aClinical 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 s 606 $aClinical trials 606 $aMedical instruments and apparatus$xResearch 615 0$aClinical trials. 615 0$aMedical instruments and apparatus$xResearch. 676 $a610.28 676 $a610.28/4072 700 $aAbdel-aleem$b Salah$01642460 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910814185203321 996 $aThe design and management of medical device clinical trials$93987183 997 $aUNINA