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The Research Question and the Hypothesis
Pages 3-9
Punto di Riferimento
per Medici e Operatori Sanitari
per Medici e Operatori Sanitari
LIBRERIA STUDIUM
Clinical Trials Design in Operative and Non Operative Invasive Procedures
Itani, Reda
Editore
Springer
Anno
2017
Pagine
495
ISBN
9783319538761
170,00 €
DA SCONTARE
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
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Primary and Secondary Endpoints
Pages 11-20
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Intervention and Control Groups
Pages 21-28
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Subject Selection
Pages 29-37
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Clinical Phases of Device and Drug Evaluation with Emphasis on Early Phase Trials
Pages 41-50
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Overview of the Randomized Clinical Trial and the Parallel Group Design
Pages 51-58
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Non-inferiority and Equivalence Trials
Pages 59-68
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Factorial Designs
Pages 69-77
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Cross-over Trials
Pages 79-86
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Cluster Randomized Clinical Trials
Pages 87-97
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Adaptive Trial Designs
Pages 99-107
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Pragmatic Trials
Pages 109-114
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Point-of-Care Clinical Trials
Pages 115-122
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Basic Statistical Considerations
Pages 125-132
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Methods and Timing of Randomization
Pages 133-140
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Sample Size Calculation
Pages 141-150
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Principles of Analysis
Pages 151-162
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Advanced Statistical Methods
Pages 163-179
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Missing Data
Pages 181-188
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Interim Monitoring
Pages 189-196
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Ethical Considerations in Clinical Trials
Pages 199-203
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IRB and Review Process for Multisite Trials
Pages 205-207
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Trial Advertising
Pages 209-210
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Payment to Research Participants
Pages 211-213
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Conflict of Interest
Pages 215-217
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Quality Control in Procedural Studies
Pages 221-234
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Pilot Studies
Pages 235-244
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Surgeon Training and the Learning Curve
Pages 245-250
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Using a Placebo or Sham Procedure as a Control: Ethics and Practicalities
Pages 251-257
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Patient Recruitment and Retention in Procedural Trials
Pages 259-267
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Equipoise in Interventional Trials
Pages 269-276
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Setting up a Clinical Trial Research Office
Pages 279-284
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Regulatory Considerations: The Clinical Research Coordinator
Pages 285-292
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Data Collection Forms
Pages 293-302
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Data Security
Pages 303-311
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Remote Monitoring of Data Quality
Pages 313-318
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Investigators’ Meetings
Pages 319-322
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Site Visits
Pages 323-328
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Data Safety Monitoring Board: Composition and Role
Pages 329-334
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Endpoints Committee
Pages 335-339
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Regulatory Issues with Devices in Clinical Trials
Pages 341-346
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Trial Registration and Public Access to Data
Pages 347-354
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Mistakes in Clinical Trials
Pages 357-367
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Combined Drugs and Procedure Trials
Pages 371-379
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Genomics in Clinical Trials
Pages 381-390
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Biomarkers as Adjuncts to Clinical Trials
Pages 391-400
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Patient-Centered Designs (and Outcomes)
Pages 401-408
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Economic Evaluations
Pages 409-426
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Telemedicine and Mobile Technology
Pages 427-431
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Budgeting for a Clinical Trial
Pages 435-440
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Funding a Clinical Trial
Pages 443-450
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Writing Your Grant for the Patient-Centered Outcomes Research Institute (PCORI)
Pages 451-457
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Designing Clinical Trials for Quality and Impact: The Department of Veterans Affairs Approach to Developing a Cooperative Study
Pages 459-470
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Publication
Pages 473-483
