Translational Sports Medicine

INTRODUCTION1. Introduction2. Translational Process3. Scientific Method4. Basic Research PRE-CLINICAL5. Overview of preclinical research6. What Problem Are You Solving?7. Types of Interventions8. Beyond Drugs and Surgery: A Look at Orthobiologics9. Drug Testing10. Device Discovery and Prototyping11. Device Testing12. Diagnostic Discovery13. Diagnostic Testing14. Preclinical: discussion of FDA product categories (what the FDA covers, regulated or not)15. Procedural Technique Development16. Behavioral Intervention studies17. Artificial Intelligence CLINICAL: FUNDAMENTALS18. Introduction to Clinical Research: What is it? Why is it Needed?19. The Question: Types of Research question and How to Develop Them20. Study Population: Who and Why Them?21. Outcome Measurements: What data is being Collected and Why?22. Optimizing the Question: Balancing Significance and Feasibility STATISTICAL PRINCIPLES23. Common Issues in Analysis24. Basic Statistical Principles25. Distribution26. Research hypotheses and Error Types27. Power28. Multivariable regression models29. How to choose appropriate bivariate test30. Categorical Variable Analyses: Chi-square, Fisher exact, Mantel-Haenszel31. Analysis of Variance: ANOVA32. Correlation33. Statistical bias34. Basic Science Statistics35. Sample Size36. Statistical Software CLINICAL: STUDY TYPES37. Design Principles: Hierarchy of Study Types38. Case Series: Design, Measures, and an Example39. Case-control Study40. Cohort Studies41. Cross-section Study42. Longitudinal Study: Design, Measures, Classic Example43. Meta-analysis44. Cost-effectiveness Study: Design, Measures, Classic Example45. Diagnostic Test Evaluation: Design, Measures, Classic Example46. Reliability Study: Design, Measures, Classic Example47. Database Types and Basic Data Management Design Principles for Healthcare Research48. Survey Studies and Questionnaires49. Qualitative Methods and Mixed Methods CLINICAL: TRIALS50. Randomized and Controlled Trials51. Nonrandomized Controlled Trials52. Historical Control: Design, Measures, Classic Example53. Cross-over Studies54. Withdrawal Studies: Design, Measures, Classic Example55. Factorial Design: Design, Measures, Classic Example56. Group or Cluster Controlled Trials: Design, Measures, Classic Example57. Hybrid Design: Design, Measures, Classic Example58. Large, Pragmatic: Clinical Trials59. Equivalence and Noninferiority: Design, Measures, Classic Example60. Adaptive Design Measures61. Randomization: Fixed or Adaptive Procedures62. Blinding: Who, When, and and How?63. Multicenter Consideration64. Phase 0 Trials: Window of Opportunity65. Registries66. Phases of Clinical Trials67. IDEAL Framework CLINICAL PREPARATION68. Patient Perspectives69. Budgeting70. Ethics and Review Boards71. Regulatory Considerations for Sports Medicine Technologies: New Drugs and Medical Devices72. Funding Approaches73. Conflicts of Interest74. Subject Recruitment75. Data Management76. A Practical Guide to Conducting Research in the Acute Setting77. Special Populatoins78. Subject Adherence79. Time-to-Event Outcomes and Survival Analysis80. Monitoring Committee in Clinical TrialsREGULATORY BASICS81. FDA Overview82. Investigational New Drug (IND) Application83. New Drug Application84. Medical Devices85. Radiation-emitting Electronic Products86. Orphan Drugs87. Biological Drugs88. Combination Products89. Cosmetics in Sports Medicine90. CMC and GxP91. Non-US Regulatory92. Post-Market Drug Safety Monitoring93. Post-Market Device Safety Monitoring CLINICAL IMPLEMENTATION94. Implementation Research95. Design and Analysis96. Mixed-methods Research97. Implementation of Multimodal Concussion Research Within Military Medical Environments98. Guideline Development PUBLIC HEALTH99. Public Health100. Edpidemiology of Sports Injuries101. Factors102. Good Questions103. Population and Environmental Specific Considerations104. Law, Policy, and Ethics105. Healthcare Institutions and Systems106.