Translational Urology covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. The reader will come to fully understand important concepts, including case-control study, prospective cohort study, randomized trial, and reliability study. Medical researchers will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in urology, and know what is needed for successful collaboration. Further, this title is an indispensable tool in grant writing and funding efforts.…mehr
Translational Urology covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. The reader will come to fully understand important concepts, including case-control study, prospective cohort study, randomized trial, and reliability study. Medical researchers will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in urology, and know what is needed for successful collaboration. Further, this title is an indispensable tool in grant writing and funding efforts. This practical, straightforward approach helps the aspiring investigator navigate challenging considerations in study design and implementation. The book provides valuable discussions of the critical appraisal of published studies in urology, allowing the reader to learn how to evaluate the quality of such studies with respect to measuring outcomes and to make effective use of all types of evidence in patient care.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
INTRODUCTION 1. Introduction 2. Translational Process 3. Scientific Method 4. Basic Research PRE-CLINCIAL 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. Other product types 13. Procedural Technique Development 14. Behavioral Intervention CLINICAL: FUNDAMENTALS 15. Introduction to clinical research: What is it? Why is it needed? 16. Study population: Who and why them? 17. Outcome measurements: What data is being collected and why? TATISTICAL PRINCIPLES 18. Common issues in analysis 19. Basic statistical principles 20. Distributions 21. Hypotheses and error types 22. Power 23. Regression 24. Continuous Variable Analyses: Student’s t-test, Rank-Sum Test, and Signed-Rank Test 25. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel 26. Analysis of variance 27. Correlation 28. Basic science statistics CLINICAL: STUDY TYPES 29. Design principles: Hierarchy of study types 30. Case series: Design, measures, classic example 31. Case-control study: Design, measures, classic example 32. Cohort study: Design, measures, classic example 33. Cross-section study: Design, measures, classic example 34. Longitudinal Study: Design, measures, classic example 35. Clinical trials: Design, measures, classic example 36. Meta-analysis: Design, measures, classic example 37. Cost-Effectiveness Analysis: Design, Measures, and Classic Example 38. Database Research in Urology 39. Surveys and questionnaires: Design, measures, classic example 40. Qualitative methods and mixed methods CLINICAL TRIALS 41. Randomized Controlled Trials: Design, Measures, and Classic Examples 42. Nonrandomized control: Design, measures, classic example 43. Historical control: Design, measures, classic example 44. Cross-over: Design, measures, classic example 45. Withdrawal Studies 46. Equivalence and noninferiority: Design, measures, classic example 47. Randomization: Fixed or adaptive procedures 48. Blinding: Who and how? 49. Multicenter considerations 50. Phases of Clinical Trials 51. Window of Opportunity, Phase 0 Trials 52. IDEAL Framework 53. Artificial Intelligence 54. Patient Perspectives CLINICAL: PREPARATION 55. Sample Size 56. Budgeting 57. Ethics and review boards 58. Regulatory considerations for new drugs and devices 59. Funding approaches 60. Data management 61. Statistical Software 62. Subject adherence 63. Survival analysis 64. Monitoring committee in clinical trials REGULATORY BASICS 65. FDA overview 66. IND 67. New drug application 68. Devices 69. Biologics 70. Combination Products 71. Foods 72. CMC and GxP 73. Post-Market Drug Safety Monitoring 74. Post-Market Device Safety Monitoring CLINICAL IMPLEMENTATION 75. Implementation Research 76. Design and Analysis 77. Population- and Setting-Specific Implementation PUBLIC HEALTH 78. Public Health 79. Epidemiology 80. Public Health Factors and Social Determinants of Health in Urological Research 81. Good Questions 82. Population- and Environmental-Specific Considerations 83. Healthcare Institutions and Systems 84. Public Health Institutions and Systems Practical Resources 85. Presenting Data 86. Manuscript Preparation 87. Building a Team 88. Patent Basics 89. Venture Pathways 90. SBIR/STTR 91. Sample Forms and Templates
INTRODUCTION 1. Introduction 2. Translational Process 3. Scientific Method 4. Basic Research PRE-CLINCIAL 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. Other product types 13. Procedural Technique Development 14. Behavioral Intervention CLINICAL: FUNDAMENTALS 15. Introduction to clinical research: What is it? Why is it needed? 16. Study population: Who and why them? 17. Outcome measurements: What data is being collected and why? TATISTICAL PRINCIPLES 18. Common issues in analysis 19. Basic statistical principles 20. Distributions 21. Hypotheses and error types 22. Power 23. Regression 24. Continuous Variable Analyses: Student’s t-test, Rank-Sum Test, and Signed-Rank Test 25. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel 26. Analysis of variance 27. Correlation 28. Basic science statistics CLINICAL: STUDY TYPES 29. Design principles: Hierarchy of study types 30. Case series: Design, measures, classic example 31. Case-control study: Design, measures, classic example 32. Cohort study: Design, measures, classic example 33. Cross-section study: Design, measures, classic example 34. Longitudinal Study: Design, measures, classic example 35. Clinical trials: Design, measures, classic example 36. Meta-analysis: Design, measures, classic example 37. Cost-Effectiveness Analysis: Design, Measures, and Classic Example 38. Database Research in Urology 39. Surveys and questionnaires: Design, measures, classic example 40. Qualitative methods and mixed methods CLINICAL TRIALS 41. Randomized Controlled Trials: Design, Measures, and Classic Examples 42. Nonrandomized control: Design, measures, classic example 43. Historical control: Design, measures, classic example 44. Cross-over: Design, measures, classic example 45. Withdrawal Studies 46. Equivalence and noninferiority: Design, measures, classic example 47. Randomization: Fixed or adaptive procedures 48. Blinding: Who and how? 49. Multicenter considerations 50. Phases of Clinical Trials 51. Window of Opportunity, Phase 0 Trials 52. IDEAL Framework 53. Artificial Intelligence 54. Patient Perspectives CLINICAL: PREPARATION 55. Sample Size 56. Budgeting 57. Ethics and review boards 58. Regulatory considerations for new drugs and devices 59. Funding approaches 60. Data management 61. Statistical Software 62. Subject adherence 63. Survival analysis 64. Monitoring committee in clinical trials REGULATORY BASICS 65. FDA overview 66. IND 67. New drug application 68. Devices 69. Biologics 70. Combination Products 71. Foods 72. CMC and GxP 73. Post-Market Drug Safety Monitoring 74. Post-Market Device Safety Monitoring CLINICAL IMPLEMENTATION 75. Implementation Research 76. Design and Analysis 77. Population- and Setting-Specific Implementation PUBLIC HEALTH 78. Public Health 79. Epidemiology 80. Public Health Factors and Social Determinants of Health in Urological Research 81. Good Questions 82. Population- and Environmental-Specific Considerations 83. Healthcare Institutions and Systems 84. Public Health Institutions and Systems Practical Resources 85. Presenting Data 86. Manuscript Preparation 87. Building a Team 88. Patent Basics 89. Venture Pathways 90. SBIR/STTR 91. Sample Forms and Templates
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