Clinical Trials Flashcards
1
Q
Small number of healthy volunteers?
A
Phase 1
2
Q
Small number of patients with disease of interest?
A
Phase 2
3
Q
Large number of patients randomly assigned either to the treatment under investigation or to the best available treatment (or placebo)
A
Phase 3
4
Q
Postmarketing surveillance of patients after treatment is approved?
A
Phase 4
5
Q
“Is it safe?” Assesses safety, toxicity, pharmacokinetics, and pharmacodynamics?
A
Phase 1
6
Q
“Does it work?” Assesses treatment efficacy, optimal dosing, and adverse effects?
A
Phase 2
7
Q
“Is it as good or better?” Compares the new treatment to the current standard of care?
A
Phase 3
8
Q
“Can it stay?” Detects rare or long-term adverse effects. Can result in treatment being withdrawn from market?
A
Phase 4
