Translational Cardiothoracic Surgery by Eltorai, Adam E.M.;

Sorozatcím: Handbook for Designing and Conducting Clinical and Translational Research;

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A termék adatai:

Kiadó Elsevier Science
Megjelenés dátuma 2026. február 1.

ISBN 9780323905329
Kötéstípus Puhakötés
Terjedelem610 oldal
Méret 276x216 mm
Nyelv angol

Kategóriák

A biológia általános kérdései Sebészet Szív- és érrendszeri betegségek

Hosszú leírás:

Translational research is essential to the advancement of medicine. Thisï¿1⁄2Cardiothoracic-specific 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 inï¿1⁄2cardiothoracic surgery,ï¿1⁄2thisï¿1⁄2volume provides a clear process for understanding, designing, executing, and analyzing clinical and translational researchï¿1⁄2within the field.

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Tartalomjegyzék:

PRE-CLINCIAL: DISCOVERY & DEVELOPMENT
1. Defining the problem to solve
2. Types of problems
3. Drug discovery
4. Device discovery
5. Device classification
6. Other product types
7. Drug safety
8. Device prototyping
9. Device testing

CLINICAL: FUNDAMENTALS
10. Introduction to clinical research: What is it? Why is it needed?
11. The question: Types of research questions and how to develop them
12. Study population: Who and why them?
13. Outcome measurements: What data is being collected and why?

STATISTICAL PRINCIPLES
14. Presenting data
15. Common issues in analysis
16. Basic statistical principles
17. Distributions
18. Hypotheses and error types
19. Power
20. Regression
21. Continuous variable analyses: t-test, Man Whitney, Wilcoxin rank
22. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel
23. Analysis of variance
24. Correlation
25. Biases
26. Basic science statistics
27. Sample forms and templates

CLINICAL: STUDY TYPES
28. Design principles: Hierarchy of study types
29. Case series: Design, measures, classic example
30. Case-control study: Design, measures, classic example
31. Cohort study: Design, measures, classic example
32. Cross-section study: Design, measures, classic example
33. Clinical trials: Design, measures, classic example
34. Meta-analysis: Design, measures, classic example
35. Cost-effectiveness study: Design, measures, classic example
36. Diagnostic test evaluation: Design, measures, classic example
37. Reliability study: Design, measures, classic example
38. Database studies: Design, measures, classic example
39. Surveys and questionnaires: Design, measures, classic example
40. Qualitative methods and mixed methods

CLINICAL TRIALS
41. Randomized control: Design, measures, classic example
42. Nonrandomized control: Design, measures, classic example
43. Historical control: Design, measures, classic example
44. Cross-over: Design, measures, classic example
45. Withdrawal studies: Design, measures, classic example
46. Factorial design: Design, measures, classic example
47. Group allocation: Design, measures, classic example
48. Hybrid design: Design, measures, classic example
49. Large, pragmatic: Design, measures, classic example
50. Equivalence and noninferiority: Design, measures, classic example
51. Adaptive: Design, measures, classic example
52. Randomization: Fixed or adaptive procedures
53. Blinding: Who and how?
54. Multicenter considerations
55. IDEAL Framework

CLINICAL: PREPARATION
56. Optimizing the question: Balancing significance and feasibility
57. Meaningful outcome measurements
58. Sample size
59. Budgeting
60. Ethics and review boards
61. Regulatory considerations for new drugs and devices
62. Funding approaches
63. Subject recruitment
64. Data management
65. Quality control
66. Report forms: Harm and Quality of Life
67. Subject adherence
68. Survival analysis
69. Monitoring committee in clinical trials

REGULATORY
70. FDA overview
71. New drug application
72. Device pathways
73. Non-US regulatory
74. Post-Market Drug Safety Monitoring
75. Post-Market Device Safety Monitoring