Clinical Trial Design Flashcards
Why can clinical impressions of a drugs efficacy be dodgy?
- Bias
- Selective memories
- Placebo effect
Definition of a clinical trial?
The way in which the efficacy of a drug can be tested and proven
Additionally to efficacy testing, what can clinical trials tell you about a drug?
Risks
What 3 things does the reliability of the conclusion depend on?
- Trial design
- Trial procedure
- Trial analysis
What is important to the study design with reference to the aims?
- How many subjects should be studied?
- How should the study be carried out?
- Should a placebo be used?
- Is a placebo ethical?
What different ways are there for the study to be carried out?
- Randomised
- Double blind
- Crossover
- Parallel
What is important with reference to the results?
- How they should be assessed
- Should they be perspective or not
- What dosage regime is used
What is a parallel study?
- One group receives treatment A
- Another group receives treatment B
What is a crossover study?
- One group receives treatment A followed by B
- One group receives treatment B followed by A
When is a parallel study useful?
The disease shows signs of progression
When is a crossover study useful?
- Each patient is their own control
- Require fewer subjects
What groups are usually excluded from the trial?
- Pregnant women
- Children
- Elderly
- Seriously ill
