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Clinical Trials Design in Operative and Non Operative Invasive Procedures

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Cover of 'Clinical Trials Design in Operative and Non Operative Invasive Procedures'

Table of Contents

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    Book Overview
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    Chapter 1 The Research Question and the Hypothesis
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    Chapter 2 Primary and Secondary Endpoints
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    Chapter 3 Intervention and Control Groups
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    Chapter 4 Subject Selection
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    Chapter 5 Clinical Phases of Device and Drug Evaluation with Emphasis on Early Phase Trials
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    Chapter 6 Overview of the Randomized Clinical Trial and the Parallel Group Design
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    Chapter 7 Non-inferiority and Equivalence Trials
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    Chapter 8 Factorial Designs
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    Chapter 9 Cross-over Trials
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    Chapter 10 Cluster Randomized Clinical Trials
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    Chapter 11 Adaptive Trial Designs
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    Chapter 12 Pragmatic Trials
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    Chapter 13 Point-of-Care Clinical Trials
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    Chapter 14 Basic Statistical Considerations
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    Chapter 15 Methods and Timing of Randomization
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    Chapter 16 Sample Size Calculation
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    Chapter 17 Principles of Analysis
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    Chapter 18 Advanced Statistical Methods
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    Chapter 19 Missing Data
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    Chapter 20 Interim Monitoring
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    Chapter 21 Ethical Considerations in Clinical Trials
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    Chapter 22 IRB and Review Process for Multisite Trials
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    Chapter 23 Trial Advertising
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    Chapter 24 Payment to Research Participants
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    Chapter 25 Conflict of Interest
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    Chapter 26 Quality Control in Procedural Studies
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    Chapter 27 Pilot Studies
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    Chapter 28 Surgeon Training and the Learning Curve
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    Chapter 29 Using a Placebo or Sham Procedure as a Control: Ethics and Practicalities
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    Chapter 30 Patient Recruitment and Retention in Procedural Trials
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    Chapter 31 Equipoise in Interventional Trials
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    Chapter 32 Setting up a Clinical Trial Research Office
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    Chapter 33 Regulatory Considerations: The Clinical Research Coordinator
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    Chapter 34 Data Collection Forms
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    Chapter 35 Data Security
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    Chapter 36 Remote Monitoring of Data Quality
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    Chapter 37 Investigators’ Meetings
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    Chapter 38 Site Visits
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    Chapter 39 Data Safety Monitoring Board: Composition and Role
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    Chapter 40 Endpoints Committee
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    Chapter 41 Regulatory Issues with Devices in Clinical Trials
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    Chapter 42 Trial Registration and Public Access to Data
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    Chapter 43 Mistakes in Clinical Trials
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    Chapter 44 Combined Drugs and Procedure Trials
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    Chapter 45 Genomics in Clinical Trials
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    Chapter 46 Biomarkers as Adjuncts to Clinical Trials
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    Chapter 47 Patient-Centered Designs (and Outcomes)
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    Chapter 48 Economic Evaluations
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    Chapter 49 Telemedicine and Mobile Technology
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    Chapter 50 Budgeting for a Clinical Trial
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    Chapter 51 Funding a Clinical Trial
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    Chapter 52 Writing Your Grant for the Patient-Centered Outcomes Research Institute (PCORI)
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    Chapter 53 Designing Clinical Trials for Quality and Impact: The Department of Veterans Affairs Approach to Developing a Cooperative Study
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    Chapter 54 Publication
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Title
Clinical Trials Design in Operative and Non Operative Invasive Procedures
Published by
Springer International Publishing, January 2017
DOI 10.1007/978-3-319-53877-8
ISBNs
978-3-31-953877-8, 978-3-31-953876-1
Editors

Kamal Itani, Domenic Reda

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X Demographics

The data shown below were collected from the profiles of 5 X users who shared this research output. Click here to find out more about how the information was compiled.
Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 23 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 23 100%

Demographic breakdown

Readers by professional status Count As %
Student > Ph. D. Student 5 22%
Other 3 13%
Researcher 3 13%
Student > Doctoral Student 1 4%
Professor 1 4%
Other 4 17%
Unknown 6 26%
Readers by discipline Count As %
Medicine and Dentistry 6 26%
Biochemistry, Genetics and Molecular Biology 3 13%
Engineering 3 13%
Agricultural and Biological Sciences 1 4%
Mathematics 1 4%
Other 2 9%
Unknown 7 30%