Clinical Trials Design in Operative and Non Operative Invasive Procedures

 
 
Springer (Verlag)
  • erschienen am 16. Mai 2017
  • |
  • XXIV, 495 Seiten
 
E-Book | PDF mit Wasserzeichen-DRM | Systemvoraussetzungen
978-3-319-53877-8 (ISBN)
 
The aim of this text is to provide the framework for building a clinical trial as it pertains to operative and non operative invasive procedures, how to get it funded and how to conduct such a trial up to publication of results
The text provides all details of building a scientifically and ethically valid proposal, including how to build the infrastructure for a clinical trial and how to move it forward through various funding agencies. The text also presents various types of clinical trials, the use of implantable devices and FDA requirements, and adjuncts to clinical trials and interaction with industry
Clinical Trials Design in Invasive Operative and Non Operative Procedures will be of interest to all specialists of surgery, anesthesiologists, interventional radiologists, gastroenterologists, cardiologists, and pulmonologists
1st ed. 2017
  • Englisch
  • Cham
  • |
  • Schweiz
Springer International Publishing
  • 160
  • |
  • 27 farbige Abbildungen, 15 s/w Abbildungen, 25 farbige Tabellen, 160 s/w Tabellen
  • |
  • 15 schwarz-weiße und 27 farbige Abbildungen, 160 schwarz-weiße und 25 farbige Tabellen, Bibliographie
  • 7,13 MB
978-3-319-53877-8 (9783319538778)
10.1007/978-3-319-53877-8
weitere Ausgaben werden ermittelt
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.
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-Lévy

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

<Thomas H. Shoultz Heather L. Evans



Section IX: Budgeting



Ch. 50: Budgeting for a Clinical Trial

Eric L. Lazar





Section X: Funding



Ch. 51: Funding a Clinical Trial

Eric L. Lazar



Ch. 52: Writing Your Grant for the Patient Centered Outcomes Research Institute (PCORI)

Frances M. Weaver

Talar W. Markossian

Jennifer E. Layden



Ch. 53: Designing Clinical Trials for Quality and Impact: The Department of Veterans Affairs Approach to Developing a Cooperative Study

Grant D. Huang

Domenic J. Reda





Section XI: Publication



Ch. 54: Publication

J. Michael Gaziano

DNB DDC Sachgruppen
Dewey Decimal Classfication (DDC)

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