Clinical trial: phases Flashcards
1
Q
Determines pharmacokinetics and pharmacodynamics and side-effects prior to larger studies
A
Phase 1
2
Q
Which phase is used to Assess efficacy + dosage
A
Phase 2
3
Q
Who normally partakes in Phase 1 of a clinical trial?
A
healthy volunteers
4
Q
Who usually takes part in Phase 2 of a clinical trial
A
small number of patients affected by particular disease
5
Q
Which phase of the clinical trial aims to assess effectiveness?
A
Phase 3
6
Q
Who is usually involved in phase 3 of a clinical trial?
A
100-1000’s of patients
often as part of a randomised controlled trial
comparing new treatment with established treatments
7
Q
What is involved in Phase 4 of clinical trials
A
Post-marketing surveillance
(for long term side effects and effectiveness)
