The mnemonic
Safe, Dose, Prove, Watch
What each word stands for
- Safe (Phase I)Safety and tolerability in a few healthy volunteers
- Dose (Phase II)Efficacy and dosing in a small group of patients
- Prove (Phase III)Large randomised trials confirming efficacy
- Watch (Phase IV)Post-marketing surveillance of rare adverse effects
Why it matters clinically
Shows where in drug development each question gets answered.
Where it stops being reliable
Some drugs, such as oncology agents, differ in who is enrolled in phase I.
Teaching aid, still awaiting independent review. Confirm facts in a standard source.