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.
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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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Comprehensive how-to-reference for designing and conducting translational medicine research in urology
Focuses on the principles of evidence-based medicine and applies these principles to the design of translational investigations within the field of urology Provides a practical, straightforward approach that helps investigators navigate challenging considerations in study design and implementation Details discussions of the critical appraisal of published studies in urology, supporting evaluation with respect to measuring outcomes and making effective use of all types of evidence in patient care
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Produktdetaljer

ISBN
9780323901864
Publisert
2024-09-30
Utgiver
Vendor
Academic Press Inc
Vekt
450 gr
Høyde
276 mm
Bredde
216 mm
Aldersnivå
P, 06
Språk
Product language
Engelsk
Format
Product format
Heftet
Antall sider
516

Redaktør

Om bidragsyterne

Anthony Atala, MD, is the G. Link Professor and Director of the Wake Forest Institute for Regenerative Medicine, and the W. Boyce Professor and Chair of Urology. Dr. Atala is a practicing surgeon and a researcher in the area of regenerative medicine. Fifteen applications of technologies developed in Dr. Atala's laboratory have been used clinically. He is Editor of 25 books and 3 journals. Dr. Atala has published over 800 journal articles and has received over 250 national and international patents. Dr. Atala was elected to the Institute of Medicine of the National Academies of Sciences, to the National Academy of Inventors as a Charter Fellow, and to the American Institute for Medical and Biological Engineering. Dr. Atala has led or served several national professional and government committees, including the National Institutes of Health working group on Cells and Developmental Biology, the National Institutes of Health Bioengineering Consortium, and the National Cancer Institute’s Advisory Board. He is a founding member of the Tissue Engineering Society, Regenerative Medicine Foundation, Regenerative Medicine Manufacturing Innovation Consortium, Regenerative Medicine Development Organization, and Regenerative Medicine Manufacturing Society. Ali Arab is an Associate Professor in the Mathematics and Statistics Department of Georgetown University. He received a BS in Applied Mathematics at the Iran University of Science and Technology (1999) and an MS in Applied Mathematics and Statistics at Southern Illinois University Edwardsville (2002) and PhD in Statistics at University of Missouri-Columbia (2007). He joined Georgetown University in 2007. His academic research is mainly focused on statistical modeling, spatio-temporal models, spatial statistics, hierarchical bayesian modeling with focus on environmental and ecological studies. He frequently publishes in peer-reviewed scientific journals and publishes in academic and popular outlets on topics related to human rights. He is actively involved in promoting science and human rights including promoting the role of human rights in science education, and organizing student activities related to science and human rights. He serves as the Outreach and Communication Committee co-Chair for the American Association for the Advancement of Science (AAAS)-Science and Human Rights Coalition. Dr. Mohummad Siddiqui is a fellowship-trained specialist in Urologic Oncology and Robotic Surgery. He joined the faculty at the University of Maryland in 2014 after completing training at MIT, Harvard, and the NIH in the field of Urology and subspecialty of Urologic Oncology. He is the Director of Urologic Oncology and Robotic Surgery at the University of Maryland Medical Center. He specializes in the surgical management of urologic cancers such as prostate, bladder, kidney, and testicular cancer. Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.