Chapter 15 - Respiratory Diseases Flashcards
What is phase 1 of a clinical trial looking for?
Safety
What sample does a phase 1 trial use?
10-20 healthy people
how much does a phase 1 trial cost?
~ £710 million
what happens in a phase 1 trial?
- the patients are given low doses
- doses increase until the upper limit of a safe dose is established
What is phase 2 in a clinical trial looking for?
efficacy
what sample does a phase 2 trial use?
~ 200 people
how long does a phase 2 trial take?
~8.5 years
how much does a phase 2 trial cost?
~ £916 million
what happens in a phase 2 trial?
- 50% are given the drug and 50% are given a placebo (randomly allocated.
- determines the effectiveness of the drug
what is a phase 3 clinical trial looking for?
conformation of results
what sample does a phase 3 trial use?
1000’s of participants with the disease
how long does a phase 3 trial take?
~11 years
how much does a phase 3 trial cost?
~£1100 million
what happens in a phase 3 trial?
- trials are randomised
- participants either get the new drug or a previous established drug.
- the drug is then analysed to see if there is a significant increase in the benefit.
what considerations need to be made in a phase 3 trial?
- participants need to be of the same age group, ethnic background etc.
- gender and lifestyle need to be taken into account
