MARC Record from marc_columbia

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050 00 $aR856.4$b.A22 2010
060 00 $a2010 J-282
060 10 $aW 26$bA135d 2010
082 00 $a610.28/4072$222
100 1 $aAbdel-aleem, Salah.$0http://id.loc.gov/authorities/names/n97803410
245 14 $aThe design and management of medical device clinical trials :$bstrategies and challenges /$cSalah Abdel-aleem.
260 $aHoboken, N.J. :$bJohn Wiley,$c[2010], ©2010.
300 $axvii, 250 pages ;$c25 cm
336 $atext$btxt$2rdacontent
337 $aunmediated$bn$2rdamedia
504 $aIncludes bibliographical references and index.
505 00 $g1.$tChallenges to the Design of Clinical Study -- $tDevelopment of Clinical SOPs -- $tSelection of Study Patients, Investigators, and Study Sites -- $tDefinition of Enrolled Subjects in a Clinical Study -- $tDefinition of the Investigational Device System -- $tResearch Contract Challenges -- $tReview of Literature -- $tChallenges to the Design of the Study Protocol, Statistical Analysis Plan (SAP), and Selection of Study Endpoints -- $tMasking or Blinding -- $tPrimary and Secondary Outcomes -- $tSelection of Study Endpoints -- $tDifferences between the Primary Endpoint in FDA and CE Mark Studies -- $tSAP and Study Endpoints -- $tComponents of the SAP for Clinical Trials -- $tRoles and Responsibilities of the Clinical Personnel in Completing the Study Protocol -- $tChanging the Primary Outcome during the Conduct of the Study -- $tDefinition of Primary and Secondary Endpoints -- $tCombined "Composite" Endpoints -- $tSurrogate Endpoints -- $tReducing the Study's Sample Size -- $tStatistical Terms to Define Endpoint Measurements -- $tReporting Results of Clinical Trials -- $tSuperiority and Equivalence Trials -- $tSubgroup Analysis -- $tChallenges to ICF -- $tRisk/Benefit Analysis -- $g2.$tChallenges to Managing the Study -- $tEnhancing Patient Enrollment by Relaxation of Study Criteria -- $tCompliance with the Study Protocol -- $tChallenges Associated with Data Accuracy and Completeness -- $tData Analysis -- $tData Integrity -- $tCriteria for Using Meta-Analysis Studies -- $tWho Should have Access to Clinical Trial Records -- $tManaging Study Data and Quality Assurance -- $tMissing Data Analysis -- $tExamination of Data across Study Sites -- $tChallenges to Adverse Event Reporting -- $tAdverse Event Coding Systems -- $tProtocol Deviation Report -- $tAdverse Event Reporting in Final Study Clinical Report -- $tDifference between the US and EU Definitions and Reporting of Adverse Events -- $tAdverse Event Reporting Challenges -- $tMinimization of Bias in Clinical Trials -- $g3.$tSelection of Historic Controls -- $tTypes of Control Group in Medical Device Clinical Trials -- $tPurpose of Control Group -- $tUse of Placebo Control -- $tAdvantages of Randomized Control Clinical Trials -- $tDisadvantages of Randomized Control Clinical Trials -- $tCommonly Used Pivotal Designs -- $tDefinition of Historic Control -- $tObjective Performance Criteria (OPC) -- $tExamples of Clinical Studies with Historic Controls -- $tLACI Clinical Study -- $tLeft Ventricular Assist Devices -- $tSummary of Clinical Studies -- $tSummary of Recommendations for Historic Control -- $g4.$tFraud and Misconduct in Clinical Trials -- $tFraud and Misconduct in Clinical Trials -- $tWarning Signs of Fraud -- $tTips for Detecting Serious Misconduct -- $tFalse Claims Act -- $tFraud Prevention -- $tPolicy on Handling Complaints of Misconduct -- $tReporting Research Misconduct -- $tBioresearch Monitoring Information System (BMIS) -- $g5.$tChallenges to the Regulation of Medical Device -- $tDetermination of 510(K) Devices -- $t510(K) "Substantial Equivalence Decision Making Process" -- $tDetermination of Nonsignificant Risk Devices (NSR) -- $tSimilarities and Differences between Medical Device and Drug Regulations in Clinical Trials -- $tDefinitions of Drugs and Devices -- $tCombination Products -- $tFDA-Sponsor Meetings -- $tBIMO Inspection -- $tInvestigator-Initiated Clinical Trials -- $g6.$tChallenges of Global Clinical Studies and the CE Mark Process -- $tGlobal Trial Considerations -- $tGlobal Harmonization Task Force Challenges -- $tFDA Recommendations on Acceptance of Foreign Clinical Sites -- $tOperational Tips on Conductance of Global Clinical Trials -- $tCE Mark Process and Challenges -- $tInternational Standard ISO 14155 -- $tDifferences between FDA and CE Mark Clinical Trials -- $tChallenges to CE Mark Studies -- $g7.$tChallenging FDA PMA Cases -- $tPMA P970029 (TMR 2000 Holmium Laser System) -- $tPMA P040012 Carotid Stenting for Treating Carotid Disease -- $tHistoric Control Assumptions -- $tUse of Angiographic Late Loss as Primary Endpoint in Drug-Eluting Stent PMA P070015 (Xience V DES) -- $g8.$tBioethics in Clinical Research -- $tBioethical Challenges in Clinical Studies -- $tGood Clinical Practice for the Investigator -- $tWHO Principles of GCP -- $tGuidelines and Ethical Principles -- $tIRB Review Process.
520 1 $a"Clinical 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. The Design and Management of Medical Device Clinical Trials: Strategies and Challenges 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." "Rather 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." "The Design and Management of Medical Device Clinical Trials: Strategies and Challenges 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 biologies trials."--BOOK JACKET.
650 0 $aMedical instruments and apparatus$xResearch.
650 0 $aClinical trials.$0http://id.loc.gov/authorities/subjects/sh85027069
650 12 $aClinical Trials as Topic$xmethods.$0https://id.nlm.nih.gov/mesh/D002986Q000379
650 12 $aEquipment and Supplies.$0https://id.nlm.nih.gov/mesh/D004864
650 22 $aDevice Approval.$0https://id.nlm.nih.gov/mesh/D018795
852 00 $boff,hsl$hR856.4$i.A22 2010