Translational Urology

1st Edition - September 30, 2024
Imprint: Academic Press
Editors: Anthony Atala, Ali Arab, Mohummad Minhaj Siddiqui, Adam E.M. Eltorai
Language: English
Paperback ISBN:
9 7 8 - 0 - 3 2 3 - 9 0 1 8 6 - 4
eBook ISBN:
9 7 8 - 0 - 3 2 3 - 9 0 1 8 7 - 1

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

Purchase options

World Book Day Celebration!

Save up to 30% on books and eBooks!

Shop now

Institutional subscription on ScienceDirect

Request a sales quote

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.

Title of Book
Cover image
Title page
Table of Contents
Handbook for Designing and Conducting Clinical and Translational Research
Copyright
List of contributors
Preface
Part I. Introduction
Chapter 1. Introduction
Chapter 2. Translational process
Chapter 3. Scientific methods
Chapter 4. Basic science
Part II. Pre-clinical
Chapter 5. Overview of preclinical research
Chapter 6. Preclinical: What problem are you solving?
Chapter 7. Types of interventions
Chapter 8. Drug screening
Chapter 9. Drug testing
Chapter 10. Device discovery and prototyping
Chapter 11. Device testing and regulatory approval
Chapter 12. Other product types
Chapter 13. Procedural technique development
Chapter 14. Behavioral intervention
Part III. Clinical: Fundamentals
Chapter 15. Introduction to clinical research: What is it? Why is it needed?
Chapter 16. Study population: Who and why?
Chapter 17. Outcome measurements: What data are being collected and why?
Part IV. Statistical principles
Chapter 18. Common issues in analysis
Chapter 19. Basic statistical principles
Chapter 20. Hypotheses and error types
Chapter 21. Power
Chapter 22. Regression
Chapter 23. Continuous variable analyses: Student's t-test, rank-sum test, and signed-rank test
Chapter 24. Categorical variable analyses: Chi-square, Fisher exact, and Mantel–Haenszel
Chapter 25. Analysis of variance
Chapter 26. Correlation
Chapter 27. Basic science statistics
Part V. Clinical: Study types
Chapter 28. Design principles: Hierarchy of study types
Chapter 29. Case series: Design, measures, and classic example
Chapter 30. Case-control study: Design, measures, classic example
Chapter 31. Cohort study: Design, measures, classic example
Chapter 32. Cross-sectional study: Design, measures, and classic examples
Chapter 33. Longitudinal study: Pros and cons, study design, and classic examples
Chapter 34. Clinical trials: Getting started
Chapter 35. Meta-analysis: Design, measures, and classic examples
Chapter 36. Cost-effectiveness analysis: Design, measures, and classic example
Chapter 37. Database research in urology
Chapter 38. Surveys and questionnaires
Chapter 39. Qualitative and mixed methods in urology
Part VI. Clinical trials
Chapter 40. Randomized controlled trials: Design, measures, and classic examples
Chapter 41. Nonrandomized controlled clinical trial
Chapter 42. Historical control: Design, measures, and classic example
Chapter 43. Crossover studies
Chapter 44. Withdrawal studies: Design, measures, and classic examples
Chapter 45. Equivalence and noninferiority: Design, measures, and classic example
Chapter 46. Randomization: Fixed or adaptive procedures
Chapter 47. Blinding: Who and how?
Chapter 48. Multicenter considerations
Chapter 49. Phase 0 & window of opportunity clinical trials
Chapter 50. IDEAL framework for surgical innovation
Chapter 51. Designing an artificial intelligence study in urologic research
Chapter 52. Patient perspectives
Part VII. Clinical: Preparation
Chapter 53. Sample size
Chapter 54. Budgeting for clinical trials
Chapter 55. Ethics and review boards
Chapter 56. Regulatory considerations for new drugs and devices
Chapter 57. Funding approaches
Chapter 58. Data management
Chapter 59. Statistical software
Chapter 60. Subject adherence
Chapter 61. Statistical tools for survival analysis in urology
Chapter 62. Monitoring committees in clinical trials
Part VIII. Regulatory basics
Chapter 63. FDA overview
Chapter 64. Investigational New Drugs
Chapter 65. New drug application
Chapter 66. A urologist's primer for the United States FDA approval process for medical devices
Chapter 67. Biologics
Chapter 68. Combination products
Chapter 69. Food and dietary supplements
Chapter 70. CMC sections of regulatory filings. GxP considerations
Chapter 71. Postmarket drug safety monitoring
Chapter 72. Postmarket device safety monitoring
Part IX. Clinical implementation
Chapter 73. Implementation of research
Chapter 74. Design and analysis
Chapter 75. Population- and setting-specific implementation
Part X. Public health
Chapter 76. Public health and translational urology
Chapter 77. Epidemiology
Chapter 78. Public health factors and social determinants of health in urological research
Chapter 79. Forming good research questions
Chapter 80. Population- and environmental-specific considerations
Chapter 81. Healthcare systems and institutions as research partners
Chapter 82. Public health institutions and systems
Part XI. Practical resources
Chapter 83. Data presentation for urology research
Chapter 84. Manuscript preparation: Strategies to optimize your efficiency, productivity, and success
Chapter 85. Building a team and implementing a urology care initiative
Chapter 86. Patent basics
Chapter 87. Basics of starting a company, licensing, partnerships, and acquisition
Chapter 88. F(u/i)nding your inner entrepreneur via the NIH SBIR STTR mechanisms
Chapter 89. Sample forms and templates
Glossary
Index

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

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

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

Adam E.M. Eltorai

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

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health

Translational Urology

Purchase options

World Book Day Celebration!

Institutional subscription on ScienceDirect

Anthony Atala

Ali Arab

Mohummad Minhaj Siddiqui

Adam E.M. Eltorai

Related books