Clinical Trials

Question 1

What is a clinical trial?

Answer 1

Experiment to measure the effectiveness of intervention

Question 2

What must be included in the clinical trial?

Answer 2

Control group that is given the comparitor
Randomisation - remove allocation bias
Blinding - remove psychological effect

Question 3

What are the 3 toes of blinding?

Answer 3

Block
Stratified
Minimisation

Question 4

What 4 things are calculated after a clinical trial?

Answer 4

Experimental event rate = incidence in intervention group
Control event rate = incidence in control group
Absolute risk reduction = CER-EER
Number needed to treat = 1/ARR

Question 5

What are the phases of a clinical trial?

Answer 5

PHASE I
- test safety of treatment 
- few people
PHASE II
-people top have disease 
-effectiveness and safety 
-100 patients 
PHASE III
-compare new treatment with existing one 
-side effects 
-1000 patients 
PHASE IV
-after drug marketed 
-long term side effects