U.3 K.A-8 Clinical Trials of Vaccines and Drugs Flashcards
What must vaccines and pharmaceutical drugs go through to establish that they are safe and effective before being licensed for use?
Clinical trials
What happens before a clinical trial begins?
Extensive testing on cells and animals in a laboratory
How many phases are there in a clinical trial?
3
During phase 1 of a clinical trial, how many volunteers are tested with a very small dose of the treatment?
25-30
If phase 1 of a clinical trial is successful, phase 2 will proceed. How many people who have the illness will be tested?
150-300
What is the purpose of a phase 2 trial?
To test if the treatment is safe and effective and find out the optimum dose
During phase 3 of a clinical trial how many people who have the illness are tested?
1000-2000
What happened after phase 3 if it is successful?
A licence to manufacture the treatment is sought
During phase 3 of a clinical trial people who have the illness are split into what two groups?
A test group and control group
During a clinical trial which group out of the test group and the control group will receive the treatment?
Test group
What are the members of the control group given during a phase 3 clinical trial?
A placebo
What is a placebo?
A sham treatment that lacks the active ingredient being tested
What is the placebo effect?
Where patients show an improvement in their condition psychologically as they think they have received the real treatment because of the attention they’ve had from health care staff
What does the use of a placebo allow during phase 3 clinical trial?
A valid comparison to be made between the test group and the control group
What is a blind trial?
A clinical trial where the human subjects do not know if they are receiving the active treatment or the placebo
What is a double blind trial?
A clinical trial where both the human subjects and the doctors do not know if they are receiving the active ingredient or the placebo
What does the use of a double blind trial allow during a phase 3 clinical trial?
The elimination of bias
What is randomisation during phase 3 clinical trial?
Where the details of gender, age and other details are entered into a computer and the computer puts each personal random into one of the two groups (test and control)
What does the use of randomisation during a phase 3 clinical trial help to eliminate?
Bias
How is experimental error during a phase 3 clinical trial reduced?
By using a very large sample of population and ensuring that both the test and control groups have similar people in them in terms of age, sex etc.
Apart from reducing experimental error during a phase 3 clinical trial, why else is a large sample population required?
To allow the results obtained to be subjected to statistical analysis with confidence.
