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Weekly GCP Challenge

Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.


Challenge: Adaptive Trial Design

Question Number 1:
What is an adaptive trial design?
A
 A trial that uses accumulating data to decide on how to modify aspects of the study
B
 A trial that requires more than 2 protocol amendments
C
 A trial that requires an unplanned change in the protocol
D
 A trial that requires an unplanned change in the sample size

Question Number 2:
Which of the following is the main reason for the use of an adaptive trial design?
A
 Reduces time to market
B
 Increases the quantity of data
C
 Shorter set up time
D
 Logistically simple

Question Number 3:
Which of the following would be an example of an adaptation to a trial?
A
 Increasing the sample size after review of interim data
B
 Reducing the sample size after review of interim date
C
 Removing and ineffective treatment arm and continuing other treatment arms
D
 All of the above

Question Number 4:
What is the definition of an adaptive seamless trial?
A
 One in which there is never a break in subject recruitment
B
 One in which all subjects take part in each stage of the trial
C
 One in which the final analysis will use data from patients enrolled before and after the adaptation
D
 All of the above

Question Number 5:
Which of the following would be important in determining whether an adaptive seamless design could be implemented?
A
 The need to reduce development time due to previous trial delays
B
 The population of subjects is very small
C
 Limited information about the endpoint
D
 The length of time needed to make a decision relative to the time of recruitment

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