Understanding controlled trials Flashcards
What should be considered in a controlled trial?
Hypothesis/purpose Trial design Study population Sample size Randomisation process Masking/blinding Follow up and complaince Analysis Ethical considerations
When are controlled (clinical) trials used?
New pharmaceuticals
New vaccines
Different treatment techniques
Different management interventions
What is a clinical trial?
Trial with sick animals and treatments
What is a field/intervention study?
Trial with normal animals and prophylaxis
Controlled clinical trials compare what two groups?
Treatment group Control group (either no treatment, or normal treatment if looking for new therapies)
What are the 4 phases to a clinical trial?
Phase I - small safety trial
II - small number with no control
III - large scale randomised controlled trial
IV - evaluate use
What trials provide the strongest evidence?
Randomised controlled trials
What does random allocation of treatment reduce?
Bias and confounding
What type of bias does blinding reduce?
Measurement bias