phase II trial

Question 1

what are the 2 aims of phase 2 trials?

Answer 1

aim 1: test antitumor activitya at the phase I MTD of a drug

aim2: make decision wether drug is ineffective to stop the study based on interim analysis

Question 2

what is the design of phase 2 trial?

Answer 2

usually single arm studies with tumor response as endpoint for reasons of efficency

Question 3

whats considered a non respnder?

Answer 3

if patient goes off treatment before disease assessment

Question 4

p is

Answer 4

probability of response

Question 5

p0 is?

Answer 5

the probility of less than the historical response which if true means the agent is not worth studying further

Question 6

p1 is ?

Answer 6

the probability that the response is great than historic controls and worth studying further

Question 7

alpha error

Answer 7

probability of false positive

acceptable false positive rate is 0.05

Question 8

beta error

Answer 8

probability of false negative

power of 0.9 is false negative rate

Question 9

purpose of interim analysis is to see if your drug is ?

Answer 9

completely useless and the study should be stopped

Question 10

bigger the number in sample size causes?

Answer 10

more narrow peaks

Question 11

you have to reach the minimal accrual that you have planned in order to continue the study which was calculated by?

Answer 11

alpha
beta
and certain delta

Question 12

if youre getting good responses can you stop study before having all patients you planned to accrue?

Answer 12

No. you need all people planned accrued to make sure drug is working properly

Question 13

if you have multiple interim analysis you cannot use same p value

Answer 13

you have to be much more stringent (precise)

Question 14

hazard function

Answer 14

probability of death at time t given that the patient is alive just before time t