clinical trial Flashcards
what dose a clinical trial provide
evidence
what dose the MHRA do
test the efficacy of a drug - compared to others and a placebo
safety
what is the first stage in development
drug discovery
dogs and insulin
what is pre clinical development
using animal pharmacology and toxicology as well as tissue cultures to determine the dose andverse effects and any mutations befor a clinical trial
what is clinal developments phase 1 and what is it used for
volunteer studies in normal people
generating pharmacokinetic, metabolic and pharmacodynamic data
100 subjects
what is phase 2 of clinical developments
looking at the pharmacokinetics/dynamics in a patient who may have ADME problems
look at a dosage range
what is phase 3 in a clinical trial
involves 1000-3000
fomall thereputic rtrials
at completion - apply for drug licence
what is phase 4
post market survalence
long term safety
what is a pilot study
test desing and not to estimate outcome
what are the 4 types of clinical trial
double blind - patient and doctor don’t know
single blind - only patient that dosent know
prospective - protocol desided befor hand
retrospective - open to bias - look after completion
what is a cross over design
to compare outcomes of A against B
what is the advantages/ disadvantages of randomised
gold standard
need more patients
subjects tend to not reperesent the population as a whole
what are superiority desing and non inferioirity trying to show
new treatment is better
treatment is not worse
what are some of the ethics to be considerd
is it ethical to give a placebo
what is the salue usually taken as a statisticaluy significant probability of the null hypotheisi being true (p value|)
P<0.05
