Clinical Trials Flashcards
1
Q
Describe the purpose of Clinical Trials.
A
- Establish efficacy
- Confirm absence of toxicity (in humans)
- Identify Type A adverse drug reactions (toxicity)
- Loosely divided into 4 phases
2
Q
Describe Phase I of a clinical trial.
A
Tests for Safety
o Route of administration
o Frequency of dosing
o Mechanism of action
3
Q
Describe Phase II of a clinical trial.
A
Tests for Efficacy
- Up to 1000 people with disease
- Conducted usually as open-label, single arm study but can be double-blind, placebo studies
4
Q
Describe Phase III of a clinical trial.
A
Tests for better efficacy (+ safety) than best drugs or placebo
- Broader eligibility criteria
- Conducted in double-blind, RANDOMISED clinical trial against best drug or a placebo drug
- Confirms test drug is better than best drug or placebo
- Needed for drug approval documentation
- About ¼ drugs tested in Phase III reach approval
5
Q
Describe Phase IV of a clinical trial.
A
Post-approval Safety
- Further evaluation of long-term safety and effectiveness of new treatment
