Clinical Trials Design in Operative and Non Operative Invasive Procedures

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 ethical...

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Bibliographic Details
Corporate Author SpringerLink (Online service)
Other Authors Itani, Kamal M.F (Editor), Reda, Domenic J. (Editor)
Format Electronic eBook
LanguageEnglish
Published Cham : Springer International Publishing : Imprint: Springer, 2017.
Subjects
Medicine.
Anesthesiology.
Interventional radiology.
Cardiology.
Surgery.
elektronické knihy
electronic books
Online AccessFull text
ISBN9783319538778
DOI10.1007/978-3-319-53877-8
Physical DescriptionXXIV, 495 p. 42 illus., 27 illus. in color. online resource.

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Table of 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
  • Publication.

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