U3: 24- 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 clinical 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 to 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 to 300
What is the purpose of phase 2?
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 will be tested?
1000 to 2000
What happens after phase 3 if it is successful?
A license to manufacture the treatment is sought
During phase 3 of a clinical trail people who have the illness are split into what two groups?
A test group and a control group
During a clinical trial which group will receive the treatment?
Test group
What are members of the control group given?
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 healthcare staff
What does the use of a placebo allow?
A valid comparison to be made between the test group and the control group
What is a blind trial?
A clinical trail 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 human subjects and their doctors do not know who is receiving the active treatment or the placebo
What does a double blind trial allow?
The elimination of bias
What is randomisation during a phase 3 clinical trial?
Where the details of the human subjects (including gender and age) are entered into a computer and the computer puts each person at random into one of the two groups
What does the use of randomisation help to eliminate?
bias
How is experimental error during a phase 3 clinical trial reduced?
By using a very large sample population and ensuring that both the test and control groups have similar people in terms of age, gender, etc.
Apart from reducing experimental error why else is a large sample population required?
To allow the results obtained to be subjected to statistical analysis with confidence
