7- clinical trials overview Flashcards
what things are looked for in drug testing in humans?
- Safety
- Efficacy
- Dose range finding (based on animal numbers)
what must the drug be made in accordance to?
Good Manufacturing Practice (GMP)
how much of the cost of the new drug is taken up in clinical trials?
60 to 70 % of the cost of new drug
how many phases of trial?
3 main phases
what are double blind studies?
- Compare two groups of patients → one gets the drug, other gets the placebo
- Patient does not know which group they are in
- Doctor does not know which patients are getting placebos
what is the true effect of the treatment?
subtracting the effects of the placebo group from the effects of the treatment group
what is the nuremberg code placed for? what are some characteristics of it?
- placed for ethical reasons
- Participation is voluntary
- Informed consent
- Prior animal studies
- Benefits outweigh risks
- Qualified scientists
- No suffering
when was the nuremberg code instituted and why?
- created to prevent the atrocities carried out by the Nazis
- sought to improve the quality of experimental results
how many people are tested during phase one? and how long does it require?
- small number of healthy volunteers (<100)
- requires less than 1 year
what is the purpose of phase one?
Safety only (try to find maximum safe dose)
how much of the IND’s fail during phase one?
30%
how many people are tested during phase two? and how long does it require?
- small number of patients (200-300)
- requires less than 1 year
what is the purpose of phase two?
- safety and efficacy
- establish effective dose
how much of the IND’s fail during phase two?
70%
how many people are tested during phase three? and how long does it require?:
- thousands of patients
- 1-4 years
