Study Set Content:
Phases I to III
pre-marketing clinical trials
Phase IV
post-marketing surveillance
evaluate safety & efficacy of the new compound
Phases I to III
• identify and monitor new additional adverse drug events in a global scale
Phase IV
include observational studies where the long-term effectiveness and safety will be evaluated
Phase 4
Small number of patients: 100-
Pre-marketing clinical trials
Age and gender limitation
Pre-marketing clinical trials
Big number of patients: >10000
Post-marketing monitoring
No age and gender limitation
Post-marketing monitoring
Patients selected with precise diagnosis
Pre-marketing clinical trials
Well defined and short duration: 1-3 years
Pre-marketing clinical trials
Careful and constant follow-up
Pre-marketing clinical trials
Patients not selected; more rando
Post-marketing monitoring
Undefined and longer duration
Post-marketing monitoring
Casual and less constant follow-up
Post-marketing monitoring
Highly detailed reports
Pre-marketing clinical trials
Much less detailed reports
Post-marketing monitoring
Use less specific terminology
Post-marketing monitoring
Use specific terminology
Pre-marketing clinical trials
Possible concomitant treatments
Post-marketing monitoring
