Statistical Issues in Drug Research & Development

By Karl E. Peace, Ph.D.
Georgia Cancer Coalition Distinguished Cancer Scholar
Founding Director, Center for Biostatistics
Professor of Biostatistics
Jiann-Ping Hsu College of Public Health
Georgia Southern University

Required Text

Peace, KE (Editor and Author Contributor): Statistical Issues in Drug Research and Development: Marcel Dekker, Inc., New York, NY 1989.

Course Topics

1. Background
   
2. Constructing Statistical Hypotheses to Reflect Study Objectives
   
3. Confidence Intervals versus P-Values as a basis for Inferences?
   
4. P-Values: One-Sided or Two-Sided?
   
5. Sample Sizes for Clinical Trials in the Clinical Development Plan
   
6. The Statistical Analysis Plan (SAP)
   
7. Larger but a Fewer Number versus Smaller but a Greater Number of Clinical Trials?
   
8. The Use of the Global Null Hypothesis in Clinical Trials
   
9. Dual Control Groups Rodent Carcinogenicity Studies?
   Dual Control Group Rodent Carcinogenicity Studies Examples
   
10. The Use of Crossover Trials in the Clinical Development of Drugs
    
11. Positive Controlled Clinical Trials [aka: Active Controlled Equivalence Studies (ACES) or Non-Inferiority Trials]
    
12. The Use of Placebo in Combination Drug Development
    
13. Biostatistical Aspects of the Development of Anti-Anginal Drugs
    
14. Intention to Treat in Clinical Trials
    
15. Interim Analyses in Clinical Trials
    
16. The Analysis of Dose Response Clinical Trials
    
17. Multiple Inferences in Clinical Trials
    
18. Dosing in Special Populations in Clinical Trials (e.g. The Elderly, Females, Children, Race or Ethnicity, Severity of Disease)
    
19. Pooling of Data in Multi-Center Clinical Trials
    
20. Design and Analysis Considerations for Safety Data Particularly Adverse Events
    
21. Analysis and Summarization of Safety Data from Clinical Trials
    
22. Meta-Analyses
    
23. Other