First Aid: Behavioral Sciences

Question 1

Describe the different phases of drug study.

Answer 1

Phase I: is it safe in healthy people (Pk/Pd)
Phase II: does it work in a small number of people with the disease; are there risks with the disease interaction
Phase III: large number of patients compared to the placebo/standard of care
Phase IV: post-marketing surveillance

Question 2

What are sensitivity and specificity?

Answer 2

Sensitivity: what percentage of true positives are caught by the test?
Specificity: what percentage of true negatives are detected