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Elsevier

Translational Urology

  • 1st Edition - September 30, 2024
  • Latest edition
  • Editors: Anthony Atala, Ali Arab, Mohummad Minhaj Siddiqui, Adam E.M. Eltorai
  • Language: English

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… Read more

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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.

Key features

  • 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

Readership

Residents in Urology or Uro-oncology, Research and clinical fellows, Young staff members, Research assistants, Physicians with research interest

Table of 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

Product details

  • Edition: 1
  • Latest edition
  • Published: September 30, 2024
  • Language: English

About the editors

AA

Anthony Atala

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.
Affiliations and expertise
G. Link Professor and Director of the Wake Forest Institute for Regenerative Medicine; W. Boyce Professor and Chair, Department of Urology, and G. Link Professor and Director, Wake Forest Institute for Regenerative Medicine, Wake Forest University. Winston Salem, North Carolina, USA

AA

Ali Arab

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.
Affiliations and expertise
Department of Mathematics and Statistics, Georgetown University, Washington, DC, United States

MS

Mohummad Minhaj Siddiqui

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.

Affiliations and expertise
Professor of Surgery - Urology, University of Maryland School of Medicine Chief of Urology, Baltimore VA Medical Center Director of Urologic Oncology, University of Maryland Medical Center Director of Robotic Surgery, University of Maryland Medical System 29 S Greene St | Suite 500 | Baltimore MD 21201

AE

Adam E.M. Eltorai

Dr 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.

Affiliations and expertise
Harvard Medical School, Boston, MA, USA

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