Clinical Trials Design in Operative and Non Operative Invasive Procedures

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Table of Contents Clinical Trials Design in Invasive Operative and Non Operative Procedures Editors: Kamal M.F. Itani, Domenic J. Reda Section I: Basic Principles Ch. 1: The Research Question and the Hypothesis Peter R. Nelson Ch. 2: Primary and Secondary Endpoints Peter R. Nelson Ch. 3: Intervention and Control Groups Peter R. Nelson Ch. 4: Subject Selection Peter R. Nelson Section II: Study Designs Ch. 5: Clinical Phases of Device and Drug Evaluation with Emphasis on Early Phase Trials Domenic J. Reda Ch. 6: Overview of the Randomized Clinical Trial and the Parallel Group Design Domenic J. Reda Ch. 7: Non-Inferiority and Equivalence Trials Domenic J. Reda Ch. 8: Factorial Designs Domenic J. Reda Ch. 9: Cross-over Trials Domenic J. Reda Ch. 10: Cluster-Randomized Clinical Trials William G. Hendreson Ch. 11: Adaptive Trial Designs Joshua S. Richman Judy C. Boughey < Ch. 12: Pragmatic Trials Ryan E. Ferguson Louis Fiore Ch. 13: Point of Care Clinical Trials Mary T. Brophy Ryan E. Ferguson Statistical Considerations Ch. 14: Basic Statistical Considerations Eileen M. Stock Kousick Biswas Ch. 15: Methods and Timing of Randomization Robert George Edson Ch. 16: Sample Size Calculation Eileen M. Stock Kousick Biswas Ch. 17: Principles of Analysis Gary R. Johnson Tassos C. Kyriakides Ch. 18: Advanced Statistical Methods Hui Wang Ilana Belitskaya-Levy Mei-Chiung Shih Ying Lu Ch. 19: Missing Data Kousick Biswas Ch. 20: Interim Monitoring Joseph F. Collins Section IV: Ethical Considerations Ch. 21: Ethical Considerations in Clinical Trials Jennifer Tseng Peter Angelos Ch. 22: IRB and review process for multisite trials Jennifer Tseng Peter Angelos Ch. 23: Trial advertising Jennifer Tseng Peter Angelos Ch. 24: Payment to research participants Jennifer Tseng Peter Angelos Ch. 25: Conflict of Interest Jennifer Tseng Peter Angelos Section V: Considerations Specific to Surgical or Procedural Trials Ch. 26: Quality Control in Procedural Studies Nicole E. Lopez Lawrence T. Kim Ch. 27: Pilot Studies Ryan E. Ferguson Mary T. Brophy Ch. 28: Surgeon training and the learning curve Kamal M.F. Itani Ch. 29: Using a placebo or sham procedure as a control: ethics and practicalities Joshua S. Richman Ch. 30: Patient Recruitment and Retention in Procedural Trials Drew Moghanaki Tomer Z. Karas Ch. 31: Equipoise in Interventional Trials Judy C. Boughey Section VI: Regulatory Considerations Ch. 32: Setting up a clinical trial research office Kamal M.F. Itani Ch. 33: Regulatory Considerations: The Clinical Research Coordinator Marie Campasano Kamal M.F. Itani Ch. 34: Data Collection Forms William G. Henderson Marie Campasano Ch. 35: Data Security Jennifer M. Gabany Kamal M.F. Itani Ch. 36: Remote Monitoring of Data Quality Jennifer M. Gabany Ch. 37: Investigators meetings Kamal M.F. Itani Ch. 38: Site Visits Kamal M.F. Itani Ch. 39: Data Safety Monitoring Board: Composition and Role Marco A. Zenati William G. Henderson Ch. 40: Endpoints committee Leigh Neumayer William G. Henderson Ch. 41: Regulatory Issues with Devices in Clinical Trials Gregory Campbell Ch. 42: Trial registration and public access to data Shachar Laks Lawrence T. Kim Yvonne Lucero Section VII: Common Errors Ch. 43: Mistakes in Clinical Trials< William G. Henderson Section VIII: Adjuncts to clinical trials Ch. 44: Combined drugs and procedure trials Ankur Kalra Deepak L. Bhatt Ch. 45: Genomics in Clinical Trials Peter R. Nelson Ch. 46: Biomarkers as Adjuncts to Clinical Trials George Z. Li Jiping Wang Ch. 47: Patient-centered Designs (and Outcomes) Frances M. Weaver Ch. 48: Economic Evaluations Denise M. Hynes Leigh Neumayer Ch. 49: Telemedicine and mobile technology

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• Medicina cardiovascular
• Anestesia
• Cirurgia geral
• Radiologia