Description
Clinical Trials Design in Operative and Non Operative Invasive Procedures, Softcover reprint of the original 1st ed. 2017
Coordinators: Itani Kamal M.F., Reda Domenic J.
Language: EnglishSubjects for Clinical Trials Design in Operative and Non Operative...:
Publication date: 05-2017
Support: Print on demand
Publication date: 07-2018
Support: Print on demand
Description
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/li>Biography
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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
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 NeumayerWilliam 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. KimYvonne 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
Provides the framework for building a clinical trial as it pertains to operative and non operative invasive procedures
Written by experts in the field
Provides details of building a scientifically and ethically valid proposal
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