Clinical trials

Question 1

Why have a clinical trail?

Answer 1

to provide evidence - what medical practice relies on. to test efficacy and safety of treatments

Question 2

What are some things to take into account when designing a clinical trial?

Answer 2

Time scale
End points - e.g. death, hospital, desired effect
Choice of control - placebo, other drug
Choice of patients - age, race, actual drug
exclusion criteria - no preggers, children, old people, seriously ill

Question 3

what is meant by false positives?

Answer 3

just because there is a correlation doesn’t mean one is causing the other

Question 4

whats good about the crossover design?

Answer 4

removes patient variation,
less patients needed
patients can give opinion

Question 5

whats bad about cross over design?

Answer 5

treatments may not be separated by the wash out period

one treatment may effect other

Question 6

whats good about parallel design?

Answer 6

don’t need wash out period - takes less time

Question 7

whats bad about parallel design?

Answer 7

need more patients -patients may have different opinion about what is helping etc

Question 8

what is pre - clinical?

Answer 8

animal testing

Question 9

what is phase 1?

Answer 9

volunteer patients around 100

Question 10

what is phase 2?

Answer 10

real patients - around 500

Question 11

what is phase 3?

Answer 11

real patients - around 1000-3000

Question 12

what is phase 4?

Answer 12

thousands of patients - long term surveillance to figure out long term safety of treatment