Winston Tan

1. Winston W Tan MD FACP
Associate Professor of Medicine
Chair Education Hematology /Oncology
Mayo Clinic Florida

2. What do we want to accomplish?
 What is it
 Types
 Regulations
 Design
 Randomization
 Data management
 Analysis

3. Clinical Trial : definition
 Systematic approach to study a particular drug
/process in order to find out whether something works
or not
 Test
 Experiment
 System
 Study

4. Ethics

5. Rules have to govern it
 Code of Federation Regulation 21
 International Conference on Harmonization
Quality, safe, efficacy, make guidelines
Good Clinical Practice
Institutional Regulatory Board

6. Design
 Objective
 Target population
 Inclusion
 Exclusion
 Methods
 Statistical analysis
 Conclusion

8. Randomization
 Blinding
 Placebo
 Why

10. Sponsors
 Government
 Pharmaceutical companies
 VA
 Schools
 Private

11. Phases
 Preclinical
 Phase I dose escalation
 Phase II specific tumor type
 Phase III new drug compared with standard
 Phase IV post marketing toxcity

14. Type of trial
 Treatment
 Prevention
 Diagnostic
 Screening
 Quality of life

16. Terms
 New drug application
 Investigational new drug

21. Thank you
A journey of a thousand miles begins with a single
step
Lao Tzu
Tan.winston@mayo.edu