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Translational Radiation Oncology covers the principles of evidence-based medicine and applies them to the design of translational research. The book provides valuable discussions on the critical appraisal of published studies and recent developments in radiation oncology, allowing readers to learn how to evaluate the quality of such studies with respect to measuring outcomes and make effective use of all types of evidence. By reading this book, researchers have access to a practical approach to help them navigate challenging considerations in study design and implementation. It is a…mehr
Translational Radiation Oncology covers the principles of evidence-based medicine and applies them to the design of translational research. The book provides valuable discussions on the critical appraisal of published studies and recent developments in radiation oncology, allowing readers to learn how to evaluate the quality of such studies with respect to measuring outcomes and make effective use of all types of evidence. By reading this book, researchers have access to a practical approach to help them navigate challenging considerations in study design and implementation.
It is a valuable resource for researchers, oncologists and members of biomedical field who want to understand more about translational research applied to the field of radiation oncology. Translational medicine serves as an indispensable tool in grant writing and funding efforts, so understanding how to apply its principles to research is necessary to guarantee that results will be impactful to patients.
Provides a clear process for understanding, designing, executing and analyzing clinical and translational research
Presents practical, step-by-step guidance to help readers take ideas from the lab to the bedside
Written by a team of oncologists, radiologists and clinical research experts that fully cover translational research in radiation oncology
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INTRODUCTION 1. Introduction 2. Translational Process 3. Scientific Method 4. Basic Research PRE-CLINCIAL: DISCOVERY AND DEVELOPMENT 5. Overview of Preclinical Research 6. What problem are you Solving? 7. Types of Interventions 8. Drug discovery 9. Drug Testing 10. Device Discovery and Prototyping 11. Device Testing 12. Diagnostic Discovery 13. Diagnostic Testing 14. Procedural Technique Development 15. Behavioral Intervention 16. Artificial Intelligence CLINICAL: FUNDAMENTALS 17. Introduction to clinical research: What is it? Why is it needed? 18. The question: Types of research questions and how to develop them 19. Study population: Who and why them? 20. Outcome measurements: What data is being collected and why? 21. Optimizing the Question: Balancing Significance and Feasibility 22. Statistical Efficiency in Study Design STATISTICAL PRINCIPLES 23. Basic statistical principles 24. Distributions 25. Hypotheses and error types 26. Power 27. Regression 28. Continuous variable analyses: t-test, Man Whitney, Wilcoxin rank 29. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel 30. Analysis of variance 31. Correlation 32. Biases 33. Basic science statistics 34. Sample Size 35. Statistical Software CLINICAL: STUDY TYPES 36. Design principles: Hierarchy of study types 37. Case series: Design, measures, classic example 38. Case-control study: Design, measures, classic example 39. Cohort study: Design, measures, classic example 40. Cross-section study: Design, measures, classic example 41. Longitudinal Study: Design, Measures, Classic Example 42. Meta-analysis: Design, measures, real-world examples 43. Cost-effectiveness study: Design, measures, classic example 44. Diagnostic test evaluation: Design, measures, classic example 45. Reliability study: Design, measures, classic example 46. Database studies 47. Surveys and questionnaires: Design, measures, classic example 48. Qualitative methods and mixed methods 49. Visual analytics: design, measures, classic example CLINICAL TRIALS 50. Randomized control: Design, measures, classic example 51. Nonrandomized control: Design, measures, classic example 52. Historical control: Design, measures, classic example 53. Cross-over: Design, measures, classic example 54. Factorial design: Design, measures, classic example 55. Large, pragmatic: Design, measures, classic example 56. Equivalence and noninferiority: Design, measures, classic example 57. Adaptive: Design, measures, classic example 58. Randomization: Fixed or adaptive procedures 59. Blinding: Who and how? 60. Multicenter considerations 61. Phase 0 Trials: Window of Opportunity 62. Registries 63. Phases of Clinical Trials 64. IDEAL Framework CLINICAL: PREPARATION 65. Patient Perspectives 66. Ethics and review boards 67. Regulatory considerations for new drugs and devices 68. Funding approaches 69. Conflicts of Interest 70. Subject recruitment 71. Data management 72. Quality control 73. Special Populations 74. Report Forms: Harm and Quality of Life 75. Subject adherence 76. Survival analysis REGULATORY BASICS 77. FDA overview 78. IND 79. New drug application 80. Devices 81. Radiation-Emitting Electronic Products 82. Orphan Drugs 83. Biologics 84. Combination Products 85. CMC and GxP 86. Post-Market Drug Safety Monitoring 87. Post-Market Device Safety Monitoring CLINICAL IMPLEMENTATION 88. Implementation Research 89. Design and Analysis 90. Mixed-Methods Research 91. Guideline Development 92. Cooperative Group Research 93. Digital Health PUBLIC HEALTH 94. Public Health 95. Epidemiology 96. Factors 97. Good Questions 98. Population- and Environmental-Specific Considerations 99. Law, Policy, and Ethics 100. Public Health Institutions and Systems 101. DEI (Diversity, equity, inclusion) PRACTICAL RESOURCES102. Ethics in Scientific Publishing 103. Presenting Data 104. Manuscript Preparation 105. Promoting Research 106. Social Media 107. Quality Improvement 108. Education to translate research into practice 109. Team Science and Building a Team 110. Patent Basics 111. Venture Pathways 112. SBIR/STTR 113. Sample Forms and Templates
INTRODUCTION 1. Introduction 2. Translational Process 3. Scientific Method 4. Basic Research PRE-CLINCIAL: DISCOVERY AND DEVELOPMENT 5. Overview of Preclinical Research 6. What problem are you Solving? 7. Types of Interventions 8. Drug discovery 9. Drug Testing 10. Device Discovery and Prototyping 11. Device Testing 12. Diagnostic Discovery 13. Diagnostic Testing 14. Procedural Technique Development 15. Behavioral Intervention 16. Artificial Intelligence CLINICAL: FUNDAMENTALS 17. Introduction to clinical research: What is it? Why is it needed? 18. The question: Types of research questions and how to develop them 19. Study population: Who and why them? 20. Outcome measurements: What data is being collected and why? 21. Optimizing the Question: Balancing Significance and Feasibility 22. Statistical Efficiency in Study Design STATISTICAL PRINCIPLES 23. Basic statistical principles 24. Distributions 25. Hypotheses and error types 26. Power 27. Regression 28. Continuous variable analyses: t-test, Man Whitney, Wilcoxin rank 29. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel 30. Analysis of variance 31. Correlation 32. Biases 33. Basic science statistics 34. Sample Size 35. Statistical Software CLINICAL: STUDY TYPES 36. Design principles: Hierarchy of study types 37. Case series: Design, measures, classic example 38. Case-control study: Design, measures, classic example 39. Cohort study: Design, measures, classic example 40. Cross-section study: Design, measures, classic example 41. Longitudinal Study: Design, Measures, Classic Example 42. Meta-analysis: Design, measures, real-world examples 43. Cost-effectiveness study: Design, measures, classic example 44. Diagnostic test evaluation: Design, measures, classic example 45. Reliability study: Design, measures, classic example 46. Database studies 47. Surveys and questionnaires: Design, measures, classic example 48. Qualitative methods and mixed methods 49. Visual analytics: design, measures, classic example CLINICAL TRIALS 50. Randomized control: Design, measures, classic example 51. Nonrandomized control: Design, measures, classic example 52. Historical control: Design, measures, classic example 53. Cross-over: Design, measures, classic example 54. Factorial design: Design, measures, classic example 55. Large, pragmatic: Design, measures, classic example 56. Equivalence and noninferiority: Design, measures, classic example 57. Adaptive: Design, measures, classic example 58. Randomization: Fixed or adaptive procedures 59. Blinding: Who and how? 60. Multicenter considerations 61. Phase 0 Trials: Window of Opportunity 62. Registries 63. Phases of Clinical Trials 64. IDEAL Framework CLINICAL: PREPARATION 65. Patient Perspectives 66. Ethics and review boards 67. Regulatory considerations for new drugs and devices 68. Funding approaches 69. Conflicts of Interest 70. Subject recruitment 71. Data management 72. Quality control 73. Special Populations 74. Report Forms: Harm and Quality of Life 75. Subject adherence 76. Survival analysis REGULATORY BASICS 77. FDA overview 78. IND 79. New drug application 80. Devices 81. Radiation-Emitting Electronic Products 82. Orphan Drugs 83. Biologics 84. Combination Products 85. CMC and GxP 86. Post-Market Drug Safety Monitoring 87. Post-Market Device Safety Monitoring CLINICAL IMPLEMENTATION 88. Implementation Research 89. Design and Analysis 90. Mixed-Methods Research 91. Guideline Development 92. Cooperative Group Research 93. Digital Health PUBLIC HEALTH 94. Public Health 95. Epidemiology 96. Factors 97. Good Questions 98. Population- and Environmental-Specific Considerations 99. Law, Policy, and Ethics 100. Public Health Institutions and Systems 101. DEI (Diversity, equity, inclusion) PRACTICAL RESOURCES102. Ethics in Scientific Publishing 103. Presenting Data 104. Manuscript Preparation 105. Promoting Research 106. Social Media 107. Quality Improvement 108. Education to translate research into practice 109. Team Science and Building a Team 110. Patent Basics 111. Venture Pathways 112. SBIR/STTR 113. Sample Forms and Templates
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