clinical trials Flashcards by Claire Ross

Q

considerations in trial design

A

does it work?
whats dose works?
what dose is toxic?
is it safe?
is it necessary?

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Q

stages of clinical trials

A

pre clinical
clinical

I volunteer studies
II iller patients
III former part
IV post marketing surveillance

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Q

pre clinical stage

A

animal testing

tissue culture

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Q

clinical: stage I

A

volunteer study on normal people

for pharmacokinetic data

can be bypassed- e.g chemotherapy

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Q

clinical: stage II

A

on iller patients- renal, liver, GI problems

to see efficacy and dosage

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Q

clinical: stage III

A

efficacy and safety

randomised control
crossover

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Q

clinical stage III randomised control

A

lots of patients needed

patients might refuse as not all get treatment

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Q

clinical stage III crossover

A

takes long

lots of dropouts

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