Clinical Trials Design in Operative and Non Operative Invasive Procedures
-15%
portes grátis
Clinical Trials Design in Operative and Non Operative Invasive Procedures
Reda, Domenic J.; Itani, Kamal M.F.
Springer International Publishing AG
05/2017
495
Dura
Inglês
9783319538761
15 a 20 dias
8985
Descrição não disponível.
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 aCooperative Study.- Publication.
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Pragmatic Trials;Ethical Considerations;Procedural Trials;Devices and FDA;Writing Your Grant
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 aCooperative Study.- Publication.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
