Translational research is essential to the advancement of medicine. This Cardiology-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 in Cardiology, this volume provides a clear process for understanding, designing, executing, and analyzing clinical and translational research Focusing on translational cardiovascular research, this volume covers the principles of evidence-based medicine and applies these principles to the design of translational investigationsProvides a practical, straightforward approach that will help the aspiring cardiovascular researchers navigate challenging considerations in study design and implementationDetails valuable discussions of the critical appraisal of published studies in cardiology, 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 INDICE: 1. Defining the problem to solve2. Types of problems3. Drug discovery4. Device discovery5. Device classification6. Other product types7. Drug safety8. Device prototyping9. Device testing10. Introduction to clinical research: What is it? Why is it needed?11. The question: Types of research questions and how to develop them12. Study population: Who and why them?13. Outcome measurements: What data is being collected and why?14. Presenting data15. Common issues in analysis16. Basic statistical principles17. Distributions18. Hypotheses and error types19. Power20. Regression21. Continuous variable analyses: t-test, Man Whitney, Wilcoxin rank22. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel23. Analysis of variance24. Correlation25. Biases26. Basic science statistics27. Sample forms and templates28. Design principles: Hierarchy of study types29. Case series: Design, measures, classic example30. Case-control study: Design, measures, classic example31. Cohort study: Design, measures, classic example32. Cross-section study: Design, measures, classic example33. Clinical trials: Design, measures, classic example34. Meta-analysis: Design, measures, classic example35. Cost-effectiveness study: Design, measures, classic example36. Diagnostic test evaluation: Design, measures, classic example37. Reliability study: Design, measures, classic example38. Database studies: Design, measures, classic example39. Surveys and questionnaires: Design, measures, classic example40. Qualitative methods and mixed methods41. Randomized control: Design, measures, classic example42. Nonrandomized control: Design, measures, classic example43. Historical control: Design, measures, classic example44. Cross-over: Design, measures, classic example45. Withdrawal studies: Design, measures, classic example46. Factorial design: Design, measures, classic example47. Group allocation: Design, measures, classic example48. Hybrid design: Design, measures, classic example49. Large, pragmatic: Design, measures, classic example50. Equivalence and noninferiority: Design, measures, classic example51. Adaptive: Design, measures, classic example52. Randomization: Fixed or adaptive procedures53. Blinding: Who and how?54. Multicenter considerations Registries55. IDEAL Framework56. Optimizing the question: Balancing significance and feasibility57. Meaningful outcome measurements58. Sample size59. Budgeting60. Ethics and review boards61. Regulatory considerations for new drugs and devices62. Funding approaches63. Subject recruitment64. Data management65. Quality control66. Report forms: Harm and Quality of Life67. Subject adherence68. Survival analysis69. Monitoring committee in clinical trials70. FDA overview71. New drug application72. Device pathways73. Non-US regulatory74. Post-Market Drug Safety Monitoring75. Post-Market Device Safety Monitoring76. Patent basics77. Venture pathways
- ISBN: 978-0-323-91790-2
- Editorial: Academic Press
- Encuadernacion: Rústica
- Páginas: 465
- Fecha Publicación: 01/01/2025
- Nº Volúmenes: 1
- Idioma: Inglés