E8: Phase IV (Variety of Studies: - Therapeutic Use)

Question 1

Phase IV

Therapeutic Use

Objective of Study:

Answer 1

• Refine understanding of benefit/risk relationship in general or special
  populations and/or environments
• Identify less common adverse reactions
• Refine dosing recommendation

Question 2

Phase IV

Therapeutic Use

Study Examples:

Answer 2

• Comparative effectiveness studies
• Studies of mortality/morbidity outcomes
• Studies of additional endpoints
• Large simple trials
• Pharmacoeconomic
  studies