U3 KA8 - Clinical Trials Of Vaccines Flashcards
Why are Vaccines and drugs subjected to clinical trials?
To establish their safety and effectiveness before being licensed for use.
What are the 3 types of Clinical trials?
- Randomised Trial
- Placebo-controlled trials
- Double blind trials
Describe the set up of a Randomised Trial
Participants are put into different groups at random, the researchers do not know who is in each group
There are usually two groups in a randomised trial;
- the new treatment group
- the control group (who are given a standard treatment or a placebo)
The research team can then compare results from the two groups
Give a reason as to why the trials are randomised
So that the research team can’t choose who goes into which group.
For example, they might put people who they thought were healthier or more unwell into a particular group.
This precaution helps to increase the reliability of the results.
What is a placebo?
A placebo is a dummy treatment. E.g. a pill that looks the same as the drug being tested but just contains sugar.
Describe the Placebo Effect
People can sometimes feel better when they have a placebo because they think they are having a real treatment.
Describe the set up of a Placebo controlled Trial
A group of patients is split into two groups at random. One group is given the treatment while the other is given the placebo. After a period of time the results are compared which will show if the new treatment is really having an effect.
Describe the set up of a Double Blind Trial
Here neither you nor the Health professionals know whether you are taking a placebo of the drug. this eliminates any bias
How do you reduce the experimental error in clinical trials?
- At the end of the trial, results from the two groups are compared to determine whether there are any statistically significant differences between the groups
- The two groups must be of a suitable size to reduce the magnitude of experimental error
