�Translational Interventional Radiology, a volume in the Handbook for Designing and Conducting Clinical and Translational Research series, covers the principles of evidence-based medicine and applies these principles to the design of translational investigations in Interventional Radiology. 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 Interventional Radiology, and know what is needed for successful collaboration. Further, this reference is an indispensable tool in grant writing and funding efforts. The practical, straightforward approach helps aspiring investigators navigate challenging considerations in study design and implementation. This book provides valuable discussions of the critical appraisal of published studies in Interventional Radiology, elucidating the evaluation of the quality with respect to measuring outcomes and making effective use of all types of evidence in patient care. In short, this practical guide will be of interest to every medical researcher and interventional radiologist who has ever had a good clinical idea but not the knowledge of how to test it.
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Table of Contents
INTRODUCTION 1. Translational Process; 2. Scientific Method; 3. Basic researchPRE-CLINICAL: DISCOVERY AND DEVELOPMENT 4. Overview of preclinical research; 5. Defining the problem to solve; 6. Types of problems; 7. Types of Interventions; 8. Drug discovery; 9. Drug safety; 10. Device discovery; 11. Device prototyping; 12. Device classification; 13. Device testing; 14. Diagnostic testing; 15. Other product types; 16. Procedural technique development; 17. Behavioral intervention
CLINICAL: FUNDAMENTALS 18. Introduction to clinical research: What is it? Why is it needed?; 19. The question: Types of research questions and how to develop them; 20. Study population: Who and why them?; 21. Outcome measurements: What data is being collected and why?; 22. Optimizing the question: Balancing significance and feasibility
STATISTICAL PRINCIPLES 23. Common issues in analysis; 24. Basic statistical principles; 25. Distributions; 26. Hypotheses and error types; 27. Power; 28. Regression; 29. t-test; 30. Chi-square; 31. Analysis of variance; 32. Correlation; 33. Biases; 34. Basic science statistics
CLINICAL: STUDY TYPES 35. Design principles: Hierarchy of study types; 36. Case series: Design, measures, classic example; 37. Case-control study: Design, measures, classic example; 38. Cohort study: Design, measures, classic example; 39. Cross-section study: Design, measures, classic example; 40. Longitudinal study: Design, measures, classic example; 41. Clinical trials: Design, measures, classic example; 42. Meta-analysis: Design, measures, classic example; 43. Cost-effectiveness analysis: Design, measures, classic example; 44. Diagnostic test evaluation: Design, measures, classic example; 45. Reliability study: Design, measures, classic example; 46. Surveys and questionnaires: Design, measures, classic example; 47. Qualitative methods and mixed methods
CLINICAL TRIALS 48. Randomized control: Design, measures, classic example; 49. Nonrandomized control: Design, measures, classic example; 50. Historical control: Design, measures, classic example; 51. Cross-over: Design, measures, classic example; 52. Withdrawal studies: Design, measures, classic example; 53. Factorial design: Design, measures, classic example; 54. Group allocation: Design, measures, classic example; 55. Large, pragmatic: Design, measures, classic example; 56. Equivalence and noninferiority: Design, measures, classic example; 57. Adaptive: Design, measures, classic example; 58. Randomization: Fixed or adaptive procedures; 59. Blinding: Who and how?; 60. Multicenter considerations; 61. Registries; 62. Phases of clinical trials; 63. IDEAL Framework; 64. Artificial Intelligence; 65. Patient perspectives
CLINICAL: PREPARATION 66. Meaningful outcome measurements; 67. Sample size; 68. Budgeting; 69. Ethics and review boards; 70. Regulatory considerations for new drugs and devices; 71. Funding approaches; 72. Subject recruitment; 73. Data management; 74. Quality control; 75. Statistical software; 76. Report forms: Harm and Quality of Life; 77. Subject adherence; 78. Monitoring committee in clinical trials
REGULATORY 79. FDA overview; 80. IND; 81. New drug application; 82. Device pathways; 83. Radiation-emitting electronic products; 84. Combination products; 85. Cosmetics; 86. CMC and GxP; 87. Non-US regulatory; 88. Post-Market Drug Safety Monitoring; 89. Post-Market Device Safety Monitoring
CLINICAL IMPLEMENTATION 90. Implementation Research; 91. Design and analysis; 92. Mixed-methods research; 93. Population- and setting-specific implementation
PUBLIC HEALTH 94. Public Health; 95. Epidemiology; 96. Good questions; 97. Population- and environmental-specific considerations; 98. Law, policy, and ethics; 99. Healthcare institutions and systems; 100. Public health institutions and systems
Authors
Adam E.M. Eltorai Harvard Medical School, Boston, MA, USA.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.
Tao Liu Associate Professor of Biostatistics and?Director of the Brown ARCH Data and Statistics Core, Brown University, USA. Dr Liu obtained his PhD in Biostatistics from the University of Pennsylvania.?Dr Liu is Associate Professor of Biostatistics and?Director of the Brown ARCH Data and Statistics Core. He also is a faculty member at the biostatistics core of the Lifespan/Boston/Brown Center for AIDS Research (CFAR), Brown Data Science Initiative (DSI), Advance-Clinical?Translational Research (Advance-CTR)?and an affiliated faculty member for the AMPATH Biostatistics and Data Program. His research interests are in the area of health data science and include clinical decision making, incomplete data problems, causal inference, diagnostic testing, and design of clinical trials. Rajat Chand Department of Radiology, University of North Carolina Medical Center, University of North Carolina School of Medicine, Chapel Hill, NC, United States. Dr. Rajat Chand is an Early Specialization in Interventional Radiology (ESIR) Resident at the John H. Stroger, Jr. Hospital of Cook County in Chicago, Illinois, USA. He is currently an International Outreach Chair for the Society of Interventional Radiology - Resident, Fellow, and Student section. Prior to that, he was a Communications Chair for the Society of Interventional Radiology - Resident, Fellow, and Student section and a Pediatric Service Line Chair for the Society of Interventional Radiology - Resident, Fellow, and Student section. Sanjeeva P. Kalva Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States. Sanjeeva Kalva, MD is the chief of Interventional Radiology in the Department of Radiology at Massachusetts General Hospital. He is a world-renowned expert in minimally invasive approaches to treating liver cancer. Dr. Kalva trained as an interventional radiologist in India where he served on the faculty at Kovai Medical Center and Hospital in Coimbatore. In 2004, he completed a research fellowship at Harvard Medical School followed by a fellowship in vascular and interventional radiology at Massachusetts General Hospital. He served on the faculty at Harvard Medical School and Massachusetts General Hospital until 2013 when he became the chief of Interventional Radiology at UT Southwestern Medical Center in Dallas, Texas. Dr. Kalva has published multiple research papers and book chapters in the peer-reviewed literature. His research focuses on the effectiveness of minimally invasive procedures to treat liver cancer, venous thromoboembolism, portal hypertension, varicose veins and pulmonary vascular disease including arteriovenous malformations. Dr. Kalva has won several awards for his work in interventional radiology including the Outstanding Performance Award and the Dr. Athanasoulis Award for Excellence in Teaching, both at MassachusettsGeneral Hospital. He is an active member of a number of professional associations including the Radiological Society of North America and the American College of Radiology and has also been named a fellow of the Society of Interventional Radiology.
