Translational Cardiology provides a cardiology-specific instructional guide to translational medical research that will serve as a practical, step-by-step roadmap for taking a biomedical device, potential therapeutic agent, or research question from idea through demonstrated clinical benefit. Fundamentally, the volume aims to help bridge the gap between current research and practice. Written by a team of expert medical, biomedical engineering, and clinical research experts in cardiology, this book provides a clear process for understanding, designing, executing, and analyzing clinical and translational research.…mehr
Translational Cardiology provides a cardiology-specific instructional guide to translational medical research that will serve as a practical, step-by-step roadmap for taking a biomedical device, potential therapeutic agent, or research question from idea through demonstrated clinical benefit. Fundamentally, the volume aims to help bridge the gap between current research and practice. Written by a team of expert medical, biomedical engineering, and clinical research experts in cardiology, this book provides a clear process for understanding, designing, executing, and analyzing clinical and translational research.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
Section 1. INTRODUCTION 1. Introduction 2. Translational Process 3. Scientific Method 4. Basic Research Section 2: PRE-CLINCIAL: DISCOVERY & DEVELOPMENT 5. Overview of Preclinical Research 6. What problem are you Solving? 7. Types of Structural Interventions 8. Drug discovery 9. Drug Testing 10. Device Testing 11. Diagnostic Discovery 12. Diagnostic Testing 13. Other product types 14. Procedural Technique Development 15. Behavioral Intervention Section 3: CLINICAL: FUNDAMENTALS 16. Introduction to clinical research: What is it? Why is it needed? 17. The question: Types of research questions and how to develop them 18. Study population: Who and why them? 19. Outcome measurements: What data is being collected and why? 20. Optimizing the Question: Balancing Significance and Feasibility Section 4: STATISTICAL PRINCIPLES 21. Common issues in analysis 22. Basic statistical principles 23. Distributions 24. Hypotheses and error types 25. Power 26. Regression 27. Continuous Variable Analyses: Student's t-test, Mann-Whitney U Test, Wilcoxon Signed-Rank Test 28. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel 29. Analysis of variance 30. Correlation 31. Biases 32. Basic science statistics 33. Sample Size 34. Statistical Software Section 5: CLINICAL: STUDY TYPES 35. Design principles: Hierarchy of study types 36. Case series: Design, measures, classic example 37. Case-control study: Design, measures, classic example 38. Cohort study: Design, measures, classic example 39. Cross-section study: Design, measures, classic example 40. Longitudinal Study: Design, Measures, Classic Example 41. Meta-analysis: Design, measures, classic example 42. Cost-effectiveness study: Design, measures, classic example 43. Diagnostic test evaluation: Design, measures, classic example 44. Reliability study: Design, measures, classic example 45. Database studies: Design, measures, classic example 46. Surveys and questionnaires: Design, measures, classic example 47. Qualitative methods and mixed methods Section 6: CLINICAL TRIALS 48. Randomized control: Design, measures, classic example 49. Nonrandomized control: Design, measures, classic example 50. Historical control: Design, measures, classic example 51. Cross-over: Design, measures, classic example 52. Withdrawal studies: Design, measures, classic example 53. Factorial design: Design, measures, classic example 54. Group allocation: Design, measures, classic example 55. Hybrid design: Design, measures, classic example 56. Large, pragmatic: Design, measures, classic example 57. Equivalence and noninferiority: Design, measures, classic example 58. Adaptive: Design, measures, classic example 59. Blinding: Who and how? 60. Phases of Clinical Trials 61. IDEAL Framework Section 7: CLINICAL: PREPARATION 62. Patient Perspectives 63. Budgeting 64. Ethics and review boards 65. Regulatory considerations for new drugs and devices 66. Funding approaches 67. Conflicts of Interest 68. Subject recruitment 69. Data management 70. Quality control 71. Research in Acute Settings 72. Special Populations 73. Report forms: Harm and Quality of Life 74. Subject adherence 75. Survival analysis 76. Monitoring committee in clinical trials Section 8: REGULATORY BASICS 77. FDA overview 78. IND/New Drug Application 79. Radiation-Emitting Electronic Products 80. Orphan Drugs 81. Combination Products 82. CMC and GxP 83. Non-US Regulatory 84. Post-Market Drug Safety Monitoring 85. Post-Market Device Safety Monitoring Section 9: CLINICAL IMPLEMENTATION 86. Implementation Research 87. Design and Analysis 88. Mixed-Methods Research 89. Population- and Setting-Specific Implementation 90. Guideline Development Section 10: PUBLIC HEALTH 91. Public Health 92. Epidemiology 93. Factors 94. Good Questions 95. Population- and Environmental-Specific Considerations 96. Law, Policy, and Ethics 97. Healthcare Institutions and Systems 98. Public Health Institutions and Systems Section 11: PRACTICAL RESOURCES 99. Presenting Data 100. Manuscript Preparation 101. Promoting Research 102. Quality Improvement 103. Team Science and Building a Team 104. Patent Basics 105. SBIR/STTR
Section 1. INTRODUCTION 1. Introduction 2. Translational Process 3. Scientific Method 4. Basic Research Section 2: PRE-CLINCIAL: DISCOVERY & DEVELOPMENT 5. Overview of Preclinical Research 6. What problem are you Solving? 7. Types of Structural Interventions 8. Drug discovery 9. Drug Testing 10. Device Testing 11. Diagnostic Discovery 12. Diagnostic Testing 13. Other product types 14. Procedural Technique Development 15. Behavioral Intervention Section 3: CLINICAL: FUNDAMENTALS 16. Introduction to clinical research: What is it? Why is it needed? 17. The question: Types of research questions and how to develop them 18. Study population: Who and why them? 19. Outcome measurements: What data is being collected and why? 20. Optimizing the Question: Balancing Significance and Feasibility Section 4: STATISTICAL PRINCIPLES 21. Common issues in analysis 22. Basic statistical principles 23. Distributions 24. Hypotheses and error types 25. Power 26. Regression 27. Continuous Variable Analyses: Student's t-test, Mann-Whitney U Test, Wilcoxon Signed-Rank Test 28. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel 29. Analysis of variance 30. Correlation 31. Biases 32. Basic science statistics 33. Sample Size 34. Statistical Software Section 5: CLINICAL: STUDY TYPES 35. Design principles: Hierarchy of study types 36. Case series: Design, measures, classic example 37. Case-control study: Design, measures, classic example 38. Cohort study: Design, measures, classic example 39. Cross-section study: Design, measures, classic example 40. Longitudinal Study: Design, Measures, Classic Example 41. Meta-analysis: Design, measures, classic example 42. Cost-effectiveness study: Design, measures, classic example 43. Diagnostic test evaluation: Design, measures, classic example 44. Reliability study: Design, measures, classic example 45. Database studies: Design, measures, classic example 46. Surveys and questionnaires: Design, measures, classic example 47. Qualitative methods and mixed methods Section 6: CLINICAL TRIALS 48. Randomized control: Design, measures, classic example 49. Nonrandomized control: Design, measures, classic example 50. Historical control: Design, measures, classic example 51. Cross-over: Design, measures, classic example 52. Withdrawal studies: Design, measures, classic example 53. Factorial design: Design, measures, classic example 54. Group allocation: Design, measures, classic example 55. Hybrid design: Design, measures, classic example 56. Large, pragmatic: Design, measures, classic example 57. Equivalence and noninferiority: Design, measures, classic example 58. Adaptive: Design, measures, classic example 59. Blinding: Who and how? 60. Phases of Clinical Trials 61. IDEAL Framework Section 7: CLINICAL: PREPARATION 62. Patient Perspectives 63. Budgeting 64. Ethics and review boards 65. Regulatory considerations for new drugs and devices 66. Funding approaches 67. Conflicts of Interest 68. Subject recruitment 69. Data management 70. Quality control 71. Research in Acute Settings 72. Special Populations 73. Report forms: Harm and Quality of Life 74. Subject adherence 75. Survival analysis 76. Monitoring committee in clinical trials Section 8: REGULATORY BASICS 77. FDA overview 78. IND/New Drug Application 79. Radiation-Emitting Electronic Products 80. Orphan Drugs 81. Combination Products 82. CMC and GxP 83. Non-US Regulatory 84. Post-Market Drug Safety Monitoring 85. Post-Market Device Safety Monitoring Section 9: CLINICAL IMPLEMENTATION 86. Implementation Research 87. Design and Analysis 88. Mixed-Methods Research 89. Population- and Setting-Specific Implementation 90. Guideline Development Section 10: PUBLIC HEALTH 91. Public Health 92. Epidemiology 93. Factors 94. Good Questions 95. Population- and Environmental-Specific Considerations 96. Law, Policy, and Ethics 97. Healthcare Institutions and Systems 98. Public Health Institutions and Systems Section 11: PRACTICAL RESOURCES 99. Presenting Data 100. Manuscript Preparation 101. Promoting Research 102. Quality Improvement 103. Team Science and Building a Team 104. Patent Basics 105. SBIR/STTR
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