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Handbook for Clinical Trials of Imaging and Image-Guided Interventions.
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Wiley,
2015.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Title Page ; Copyright Page; Contents; Contributors; Chapter 1 Imaging technology assessment; 1.1 Six levels of evidence: a model of technology assessments in imaging; 1.1.1 Level 1: technical efficacy; 1.1.2 Level 2: diagnostic accuracy; 1.1.3 Levels 3 and 4: impact on diagnostic thinking and therapeutic planning; 1.1.4 Level 5: patient outcomes; 1.1.5 Level 6: societal efficacy; 1.2 Case examples: introducing technology assessment methods into study design; 1.3 Conclusion; References; CHAPTER 2 Clinical trials of therapy; 2.1 Phases I, II, and III: their goals and rationale.
- 2.2 Therapeutic roles: prevention, cure, and palliation2.3 Roles of different modalities; 2.3.1 Surgery; 2.3.2 Radiation therapy; 2.3.3 Chemotherapy combinations; 2.4 Study planning; 2.4.1 Sources for protocol ideas; 2.4.2 Choice of primary and secondary objectives; 2.4.3 Ways to speed protocol writing; 2.4.4 Inclusion and exclusion criteria; 2.4.5 Subject registration and accrual goals; 2.4.6 Evaluation schedule; 2.4.7 Treatment schedule; 2.4.8 Assessment of toxicity and reporting adverse events; 2.4.9 Scheme for dose modification; 2.4.10 Data collection and documentation.
- 2.5 The protocol review process2.6 Funding and budgeting; 2.7 Enhancing protocol accrual; References; Chapter 3 Clinical trials of image-guided interventions including radiotherapy studies ; 3.1 Introduction; 3.2 Establishing the context for IGI clinical trials; 3.2.1 Clinical utilities; 3.2.2 Translational continuum; 3.2.3 Why do IGI clinical trials differ from other therapy or imaging trials?; 3.3 A paradigm for considering IGI clinical trial design; 3.4 Radiotherapy trials; 3.4.1 Preclinical radiotherapy studies; 3.4.2 Phase I radiotherapy studies; 3.4.3 Phase II/III radiotherapy studies.
- 3.5 Caveats in the design and conduct of IGI trials3.5.1 Defining the clinical trial cohort; 3.5.2 Standardization of the study procedures and quality assurance; 3.5.3 IGI trial QA; 3.5.4 IGI clinical trial endpoints: measures of success and failure; 3.6 Potential impediments to the design and conduct of IGI clinical trials; 3.6.1 Evaluation of the placebo effect; 3.6.2 Masking or blinding of investigators; 3.6.3 Impediments related to "standard of care" control interventions; 3.6.4 Rapid evolution of the IGI device and related devices: multiple similar competitive IGI devices.
- 3.6.5 The feasibility of RCTs of IGIs3.6.6 Impediments to and pitfalls in the conduct of the trial; 3.7 Special considerations and the future; 3.7.1 Conclusion; References; CHAPTER 4 Imaging as a predictor of therapeutic response; 4.1 Introduction; 4.1.1 What is a biomarker?; 4.1.2 Why do we need imaging biomarkers to direct therapy?; 4.1.3 Types of therapeutic biomarkers; 4.2 Imaging- versus tissue-based biomarkers ; 4.3 Examples of imaging biomarker applications; 4.3.1 Prognostic markers; 4.3.2 Predictive markers; 4.3.3 Early response markers.