clinical trials Flashcards
why are clinical trials important ?
they provide evidence
what is a double blind trial?
when the patient and researcher dont know if patient has drug (or placebo)
what is a single blind trail
when patient doesnt know which group they have been assigned to BUT the researcher know
leads to researcher bias
which trial leads to researcher bias ?
single blind trial
who controls/ regulates clinical trials ?
MHRA
medicine and healthcare regulatory agency
what is cross over study ?
clinical groups are swapped in the middle of study
what is a prospective study & retrospective study ?
prospective - begin with disease free individuals & see who develops the disease over time
retrospective - begin with diseased individuals & looks for common factors over time
in a clinical trail what value of p is taken as significant ?
p<0.05
what is a superiority trial?
shows that new treatment is better than existing one
what are the disadvantages of randomised clinical control trials?
- some patients will refuse
- doesnt represent population
-twice as many people are required
When the MHRA test drug efficacy in a clinical trial, what two things do they compare the efficacy of the drug with?
another drug
a placebo
What is the purpose of a pilot study?
to test clinical trial design
what trial is better to use when dealing with a small number of individuals
cross - over clinical trial design
inferiority studies show respectively?
show that the new treatment is not worse than the standard
What is the purpose of the yellow card system/scheme?
used to report adverse side effects of medication
