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...
| Συγγραφή απο Οργανισμό/Αρχή: | |
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| Άλλοι συγγραφείς: | , |
| Μορφή: | Ηλεκτρονική πηγή Ηλ. βιβλίο |
| Γλώσσα: | English |
| Έκδοση: |
Cham :
Springer International Publishing : Imprint: Springer,
2017.
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| Θέματα: | |
| Διαθέσιμο Online: | Full Text via HEAL-Link |
Πίνακας περιεχομένων:
- 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.
