trials

Question 1

before trials

Answer 1

rigorous testing on animals, including apes

Question 2

phase I

Answer 2

-usually healthy volunteers- small sample size-used to test drug safety and drug dosage

Question 3

goal of phase I

Answer 3

to establish safety, effectiveness, chosen delivery method and dosage of new treatment- important information regarding side effects

Question 4

Phase II

Answer 4

larger sample size-to test if the drug works on people with the disease- dosage- deeper evaluation of safety and effectiveness100-300n

Question 5

phase II includes

Answer 5

participants with relevant conditions

Question 6

phase III

Answer 6

full blown RCT- intervention and control group-large sample size -long time period-efficacy confirmation-deep risk/benefit analysis

Question 7

sample size of phase II

Answer 7

1000 to 3000

Question 8

phase IV

Answer 8

regular review of safety and efficacy - ensuring benefits always outweigh risks

Question 9

long term side effects and cost effectiveness measured in

Answer 9

phase IV