Outcome measures Flashcards
1
Q
What is the key outcome in phase 1 trials
A
safety and tolerability
2
Q
what is the key outcome in phase 2 trials
A
efficacy and safety
3
Q
what is the key outcome in phase 3 trials
A
efficacy for marketisation
4
Q
what is the key outcome in phase 4 trials
A
long term safety and efficacy compared to the gold standard at that dose
5
Q
What are biomarkers
A
biochemical, physiological, structural, genetic measurements indicate normal biological or pathological processes and/or pharmaceutical responses
6
Q
What are surrogate markers
A
biomarkers that predict clinically meaningful outcomes
7
Q
What is meant by clinically meaningful outcomes
A
how the patient feels, functions or survives e.g. symptom scores, health status, disability, events, death
