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Clinical Trials Design in Operative and Non Operative Invasive Procedures
Title
Clinical Trials Design in Operative and Non Operative Invasive Procedures [electronic resource] / edited by Kamal M.F. Itani, Domenic J. Reda.
ISBN
9783319538778
Publication
Cham : Springer International Publishing : Imprint: Springer, 2017.
Physical Description
XXIV, 495 p. 42 illus., 27 illus. in color : online resource.
Local Notes
Access is available to the Yale community.
Access and use
Access restricted by licensing agreement.
Summary
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.
Variant and related titles
Springer ebooks.
Other formats
Printed edition:
Format
Books / Online
Language
English
Added to Catalog
June 02, 2017
Contents
The Research Question and the Hypothesis
Primary and Secondary Endpoints
Intervention and Control Groups
Subject Selection
Clinical Phases of Device and Drug Evaluation with Emphasis on Early Phase Trials
Overview of Randomized Clinical Trial and the Parallel Group Design
Non-Inferiority and Equivalence Trials
Factorial Designs
Cross-over Trials
Cluster-Randomized Clinical Trials
Adaptive Trial Designs
Pragmatic Trials
Point of Care Clinical Trials
Basic Statistical Considerations
Methods and Testing of Randomization
Sample Size Calculation
Principles of Analysis
Advanced Statistical Methods
Missing Data
Interim Monitoring
Ethical Considerations in Clinical Trials
IRB and Review Process for Multisite Trials
Trial Advertising
Payment to Research Participants
Conflict of Interest
Quality Control in Procedural Studies
Pilot Studies
Surgeon Training and the Learning Curve
Using a Placebo or Sham Procedure as a Control: Ethics and Practicalities
Patient Recruitment and Retention in Procedural Trials
Equipoise in Interventional Trials
Setting up a Clinical Trial Research Office
Regulatory Considerations: The Clinical Research Coordinator
Data Collection Forms
Data Security
Remote Monitoring of Data Quality
Investigators Meetings
Site Visits
Data Safety Monitoring Board: Composition and Role
Endpoints Committee
Regulatory Issues with Devices in Clinical Trials
Trial Registration and Public Access to Data
Mistakes in Clinical Trials
Combined Drugs and Procedure Trials
Genomics in Clinical Trials
Biomarkers as Adjuncts to Clinical Trials
Patient-centered Designs (and Outcomes)
Economic Evaluations
Telemedicine and Mobile Technology
Budgeting for a Clinical Trial
Funding a Clinical Trial
Writing Your Grant for the Patient Centered Outcomes Research Institute (PCORI)
Designing Clinical Trials for Quality and Impact: The Department of Veterans Affairs Approach to Developing a Cooperative Study
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