Full Description
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.
Contents
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
