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Translational Pulmonology

  • 1st Edition - June 6, 2025
  • Latest edition
  • Editors: Davis A. Hartnett, Jeffrey A. Bakal, Adam E.M. Eltorai, Larisa G. Tereshchenko
  • Language: English

Translational research is essential to the advancement of medicine. Translational Pulmonology is an instructional guide to translational medical research serves as a practical… Read more

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Description

Translational research is essential to the advancement of medicine. Translational Pulmonology is an instructional guide to translational medical research serves as a practical, step-by-step roadmap for taking a biomedical device, potential therapeutic agent, or research question from idea through demonstrated clinical benefit. Fundamentally, the volume aims to help bridge the gap between current research and practice. Written by a team of expert medical, biomedical engineering, and clinical research experts in pulmonary diseases, this volume provides a clear process for understanding, designing, executing, and analyzing clinical and translational research within the field.

Key features

  • Focusing on translational pulmonary diseases research, this volume covers the principles of evidence-based medicine and applies these principles to the design of translational investigations
  • Provides a practical, straightforward approach that will help the aspiring pulmonary researchers and pulmonologists navigate challenging considerations in study design and implementation
  • Details valuable discussions of the critical appraisal of published studies in pulmonary, 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

Readership

Clinicians, pulmonologists, pulmonary and respiratory researchers, basic scientists interested in translating their research into clinical practice

Table of contents

Introduction

1. Introduction

2. Translational process

3. Scientific Method

Pre-Clinical

4. Overview of Preclinical Research

5. What Problem are You Solving?

6. Types of Interventions

7. Drug Discovery

8. Drug Testing

9. Device Discovery and Prototyping

10. Device Testing

11. Diagnostic Discovery

12. Other Product Types

13. Procedural Technique Development

14. Behavioral Intervention

15. Artificial Intelligence

Clinical: Fundamentals

16. Introduction to Clinical Research: What is it? Why is it Needed?

17. The Question: Types of Research Questions and how to Development Them

18. Study Population: Who and Why Them?

19. Outcome Measurements: What Data is Being Collected and Why?

20. Optimizing the Question: Balancing Significance and Feasibility

Statistical Principles

21. Common Issues in Analysis

22. Basic Statistical Principles

23. Hypotheses and Error Types

24. Power

25. Regression

26. Continuous Variable Analyses

27. Categorical Variable Analyses: Chi-square, Fisher Exact, Mantel Hanzel

28. Correlation

29. Biases

30. Basic Science Statistics

31. Sample Size

32. Statistical Software

Clinical: Study Types

33. Design Principles: Hierarchy of Study Types

34. Case Series: Design, Measures, Classic Example

35. Case-Control Study: Design, Measures, Classic Example

36. Cohort Study: Design, Measures, Classic Example

37. Cross-section Study: Design, Measures, Classic Example

38. Longitudinal Study: Design Measures, Classic Example

39. Meta-analysis: Design, Measures, Classic Example

40. Cost-effectiveness Study: Design, Measures, Classic Example

41. Diagnostic Test Evaluation: Design, Measures, Classic Example

42. Reliability Study: Design, Measures, Classic Example

43. Database Studies: Design, Measures, Classic Example

44. Surveys and Questionnaires: Design, Measures, Classic Example

45. Qualitative Methods and Mixed Methods

Clinical Trials

46. Randomized Control: Design, Measures, Classic Example

47. Historical Control: Design, Measures, Classic Example

48. Cross-Over: Design, Measures, Classic Example

49. Withdrawal Studies: Design, Measures, Classic Example

50. Factorial Design: Design, Measures, Classic Example

51. Group Allocation: Design, Measures, Classic Example

52. Hybrid Design: Design, Measures, Classic Example

53. Large, Pragmatic: Design, Measures, Classic Example

54. Equivalence and Noninferiority: Design, Measures, Classic Example

55. Adaptive: Design, Measures, Classic Example

56. Phase 0 Trials: Window of Opportunity

57. Registries

58. Phases of Clinical Trials

59. IDEAL Framework

Clinical: Preparation

60. Patient Perspectives

61. Budgeting

62. Ethics and Review Boards

63. Regulatory Considerations for New Drugs and Devices

64. Funding Approaches

65. Conflicts of Interest

66. Subject Recruitment

67. Data Management

68. Special Populations

69. Subject Adherence

70. Survival Analysis

71. Monitoring Committee in Clinical Trials

Regulatory Basics

72. FDA Overview

73. IND

74. New Drug Application

75. Devices

76. Orphan Drugs

77. Biologics

78. Combination Products

79. Foods

80. Cosmetics

81. CMC and GxP

82. Non-US Regulatory

83. Post-Market Drug Safety Monitoring

84. Post-Market Device Safety Monitoring

Clinical Implementation

85. Implementation Research

86. Design and Analysis

87. Mixed-methods Research

88. Population- and Setting-specific Implementation

89. Guideline Development

Public Health

90. Public Health

91. Epidemiology

92. Factors

93. Good Questions

94. Population- and Environmental-specific Considerations

95. Law, Policy, and Ethics

96. Healthcare Institutions and Systems

97. Public Health Institutions and Systems

Practical Resources

98. Presenting Data

99. Manuscript Preparation

100. Quality Improvement

101. Team Science and Building a Team

102. Patent Basics

103. Venture Pathways

104. SBIR/STTR

105. Sample Forms and Templates

Product details

  • Edition: 1
  • Latest edition
  • Published: June 12, 2025
  • Language: English

About the editors

DH

Davis A. Hartnett

Davis Hartnett, MD completed his medical degree at the Warren Alpert Medical School of Brown University and is a resident physician at Brigham and Women’s Hospital in Boston, Massachusetts in the Department of Internal Medicine. He has contributed to over 40 peer reviewed publications and over 30 academic presentations on research topics including medicolegal outcomes, healthcare access disparities, and translational medicine.

Affiliations and expertise
Harvard Medical School, Boston, MA, USA and Brigham and Women’s Hospital, Boston, MA, USA

JB

Jeffrey A. Bakal

Dr Jeff Bakal PhD, P.Stat. is the Program Director for Provincial Research Data Services at Alberta Health Services which operates the Alberta Strategy for Patient Oriented Research (SPOR) data platform and Health Service Statistical & Analytics Methods teams. He has over 10 years of experience working with Health Services data and Randomized Clinical Trials. He completed his PhD jointly with the Department of Mathematics and Statistics and the School of Physical Health and Education at Queen's University. He has worked on the methodology and analysis of several international studies in business strategy, ophthalmology, cardiology, geriatric medicine and the analysis of kinematic data resulting in several peer reviewed articles and conference presentations. His current interests are in developing statistical methodology for time-to-event data and the development of classification tools to assist in patient decision making processes.
Affiliations and expertise
Division General Internal Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton Alberta, Canada

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

LT

Larisa G. Tereshchenko

Larisa Tereshchenko is an Associate Professor of Medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University and an Adjunct Associate Professor of Electrical Engineering and Computer Science at the Cleveland State University. She has a broad background in clinical investigation, cardiology, cardiac electrophysiology and electrocardiology, biomedical engineering, biophysics, randomized controlled trials, epidemiology, biostatistics, bioinformatics, and genomics. Over the past two decades, she has led clinical studies, including randomized controlled trials, cohort, and case-control studies, and has expertise in multicenter and multidisciplinary research leadership, the building of collaborative groups, and multicohort epidemiological studies. She is an author of more than 160 original peer-reviewed manuscripts, chapters, and reviews.
Affiliations and expertise
Lerner Research Institute/Cleveland Clinic, Cleveland, OH, USA

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