Week 4

Question 1

What are clinical outcomes? (2)

Answer 1

Outcomes that show an improvement in patient’s function or overall health from their perspective and have clinical significance

Question 2

What are biomarkers? (2)

Answer 2

Any objective quantifiable characteristic of biological process
They can be functional, physiological/ biochemical or molecular

Question 3

When are biomarkers, surrogate outcomes and clinical outcomes used? (4)

Answer 3

Biomarkers- throughout preclinical and human based studies

Surrogate outcomes- usually used in phase II studies, usually used as markers of efficacy

Clinical endpoints- Used in phase III studies and at the end of phase II