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Author:   Kamal M.F. Itani ,  Domenic J. Reda
Publisher:   Springer International Publishing AG
Imprint:   Springer International Publishing AG
Edition:   1st ed. 2017
Dimensions:   Width: 15.50cm , Height: 2.90cm , Length: 23.50cm
Weight:   8.985kg
ISBN:  

9783319538761

ISBN 10:   3319538764
Pages:   495
Publication Date:   27 May 2017
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   Manufactured on demand  
We will order this item for you from a manufactured on demand supplier.

Table of Contents

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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Author Information

Kamal MF Itani MDVABHCS(112A)1400 VFW ParkwayWest Roxbury, MA 02132 Domenic Reda PhDHines CSP Coordinating Center5000 South 5th AvenueHines, IL 60141 Kamal M. F. Itani, MD, Chief of surgery at the VA Boston Health Care System is a Professor of Surgery at Boston University. Dr Itani attended medical school at the American University of Beirut, residency in surgery at Baylor College of Medicine and a research fellowship in the Department of Surgery at Duke University. Prior to his move to Boston, Dr. Itani was an Associate Professor in the Michael E. DeBakey Department of Surgery and The Assistant Dean for Graduate Medical Education at Baylor College of Medicine. He was also Chief of General Surgery at the Houston VA Medical Center and a staff surgeon at The Ben Taub General Hospital. Dr. Itani's primary clinical interest is in surgical infections, hernia repair and surgical education with a research focus on the improvement of health services and surgical outcomes within his areas of clinical interest. He is the author or co-author of more than 150 peer-reviewed journal articles, editorials, and book chapters and is the lead investigator on several clinical trials. Dr Itani is a member of various surgical organizations and has served in various leadership positions in these organizations. He currently sits on several National committees including the VA Surgical quality improvement project (VASQIP), the research committee of the American College of Surgeons, and chairs the surgical quality data use group (SQDUG), the research arm of VASQIP. He is also the course director for the American College of Surgeons clinical trials course since 2007. He is a member of the editorial board of the American Journal of Surgery, Surgical Infection, Hospital Physician, and is a reviewer for several medical and surgical journals. In addition to his various leadership roles in various surgical associations and societies, he is past President of The Association of VA Surgeons.

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