Clinical Trials Design in Operative and Non Operative Invasive Procedures

Part I. Basic Principles

1. The Research Question and the Hypothesis
Peter R. Nelson

2. Primary and Secondary Endpoints
Peter R. Nelson

3. Intervention and Control Groups
Peter R. Nelson

4. Subject Selection
Peter R. Nelson

Part II. Study Designs

5. Clinical Phases of Device and Drug Evaluation with Emphasis on Early Phase Trials
Domenic J. Reda

6. Overview of the Randomized Clinical Trial and the Parallel Group Design
Domenic J. Reda

7. Non-inferiority and Equivalence Trials
Domenic J. Reda

8. Factorial Designs
Domenic J. Reda

9. Cross-over Trials
Domenic J. Reda

10. Cluster Randomized Clinical Trials
William G. Henderson

11. Adaptive Trial Designs
Joshua S. Richman, Judy C. Boughey

12. Pragmatic Trials
Ryan E. Ferguson, Louis Fiore

13. Point-of-Care Clinical Trials
Mary T. Brophy, Ryan E. Ferguson

Part III. Statistical Considerations

14. Basic Statistical Considerations
Eileen M. Stock, Kousick Biswas

15. Methods and Timing of Randomization
Robert George Edson

16. Sample Size Calculation
Eileen M. Stock, Kousick Biswas

17. Principles of Analysis
Gary R. Johnson, Tassos C. Kyriakides

18. Advanced Statistical Methods
Hui Wang, Ilana Belitskaya-Lévy, Mei-Chiung Shih, Ying Lu

19. Missing Data
Kousick Biswas

20. Interim Monitoring
Joseph F. Collins

Part IV. Ethical Considerations

21. Ethical Considerations in Clinical Trials
Jennifer Tseng, Peter Angelos

22. IRB and Review Process for Multisite Trials
Jennifer Tseng, Peter Angelos

23. Trial Advertising
Jennifer Tseng, Peter Angelos

24. Payment to Research Participants
Jennifer Tseng, Peter Angelos

25. Conflict of Interest
Jennifer Tseng, Peter Angelos

Part V. Considerations Specific to Surgical or Procedural Trials

26. Quality Control in Procedural Studies
Nicole E. Lopez, Lawrence T. Kim

27. Pilot Studies
Ryan E. Ferguson, Mary T. Brophy

28. Surgeon Training and the Learning Curve
Kamal M. F. Itani

29. Using a Placebo or Sham Procedure as a Control: Ethics and Practicalities
Joshua S. Richman

30. Patient Recruitment and Retention in Procedural Trials
Drew Moghanaki, Tomer Z. Karas

31. Equipoise in Interventional Trials
Judy C. Boughey

Part VI. Regulatory Considerations

32. Setting up a Clinical Trial Research Office
Kamal M. F. Itani

33. Regulatory Considerations: The Clinical Research Coordinator
Marie Campasano, Kamal M. F. Itani

34. Data Collection Forms
William G. Henderson, Marie Campasano

35. Data Security
Jennifer M. Gabany, Kamal M. F. Itani

36. Remote Monitoring of Data Quality
Jennifer M. Gabany

37. Investigators’ Meetings
Kamal M. F. Itani

38. Site Visits
Kamal M. F. Itani

39. Data Safety Monitoring Board: Composition and Role
Marco A. Zenati, William G. Henderson

40. Endpoints Committee
Leigh Neumayer, William G. Henderson

41. Regulatory Issues with Devices in Clinical Trials
Gregory Campbell

42. Trial Registration and Public Access to Data
Shachar Laks, Lawrence T. Kim, Yvonne Lucero

Part VII. Common Errors

43. Mistakes in Clinical Trials
William G. Henderson

Part VIII. Adjuncts to Clinical Trials

44. Combined Drugs and Procedure Trials
Ankur Kalra, Deepak L. Bhatt

45. Genomics in Clinical Trials
Peter R. Nelson

46. Biomarkers as Adjuncts to Clinical Trials
George Z. Li, Jiping Wang

47. Patient-Centered Designs (and Outcomes)
Frances M. Weaver

48. Economic Evaluations
Denise M. Hynes, Leigh Neumayer

49. Telemedicine and Mobile Technology
Thomas H. Shoultz, Heather L. Evans

Part IX. Budgeting

50. Budgeting for a Clinical Trial
Eric L. Lazar

Part X. Funding

51. Funding a Clinical Trial
Eric L. Lazar

52. Writing Your Grant for the Patient-Centered Outcomes Research Institute (PCORI)
Frances M. Weaver, Talar W. Markossian, Jennifer E. Layden

53. Designing Clinical Trials for Quality and Impact: The Department of Veterans Affairs Approach to Developing a Cooperative Study
Grant D. Huang, Domenic J. Reda

Part XI. Publication

54. Publication
J. Michael Gaziano

Keywords: Medicine & Public Health, General Surgery, Anesthesiology, Interventional Radiology, Cardiology