lecture 5

Question 1

what is a clinical study

Answer 1

using human volunteers, intending to add medical knowledge, can be interventional or observational

Question 2

how is a clinical trial different to a clinical study

Answer 2

its purely interventional (potential treatment)

Question 3

benefit of a randomised control trial

Answer 3

treat effectiveness while minimising bias

Question 4

experimental group

Answer 4

intervention is being tested on them

Question 5

placebo group (control group)

Answer 5

has an alternative, dummy, or no intervention at all

Question 6

cohort study

Answer 6

group with similar characteristics followed over time

Question 7

case control study

Answer 7

aim to find possible cause of a condition, compare those with and without the condition

Question 8

cross sectional study

Answer 8

snapshot observation of a set of people, aim to describe variable rather than measure it

Question 9

ecological study

Answer 9

aim to understand relationship between outcome and exposure at a population level where groups have shared characteristics

Question 10

pre clinical phases

Answer 10

aim to model desired effect of the drug to predict efficacy, characterise toxicities

Question 11

phase I

Answer 11

20-80 people, safety and side effects, several months, success rate 52%

Question 12

phase II

Answer 12

100-300 people, effectiveness, obtain priliminary data on if drug works on people with certain disease, 1-4 years, success 30%

Question 13

phase III

Answer 13

1,000-3,000, bring in different population and dosages and other drugs, success 58%

Question 14

FDA approval

Answer 14

new drug application submitted after 3 phases, approved for clinical use, monitoring continues, 25-30%