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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: Designs of Clinical Trials

Question Number 1:

Which design of trial would fulfil the following criteria?

  • Usually Phase I
  • Single Arm non-comparative uncontrolled
  • Recruit small group of subjects
  • Conduct trial
  • Assess number of patients with certain event (e.g. toxicity)
  • Compare this number to the decision rule
  • If acceptable increase dosage and repeat with a new set of subjects

A
Factorial
B
Discontinuation
C
Withdrawal
D
Group Sequential

Question Number 2:

Which design of trial best describes the following criteria?

  • Usually Phase I or II
  • Uses a prior knowledge about the outcomes to treatment
  • Patients are treated in the trial
  • The analysis combines the prior knowledge with the trial data
  • This ‘updates’ the prior knowledge to generate the results

A
Two Stage
B
Factorial
C
Bayesian
D
Phase Zero

Question Number 3:

What type of design would fulfil the following criteria?

  • Usually Phase II or III
  • one group assigned treatment A
  • one group assigned treatment B
  • one group assigned A and B in combination
  • one group assigned neither A or B
  • Compare A vs B, A vs A+B, B vs A+B etc etc

A
Factorial
B
Randomised Discontinuation
C
Two Stage
D
Single Sequential

Question Number 4:

Which trial design can be described by the following criteria:

  • Usually Phase II
  • Determine
    • R1 – level of efficacy where trial is stopped and drug is ‘failed’
    • N – number of patients initially recruited
  • Recruit N patients
  • Generate results from N patients and compare with R1
  • If R1 is exceeded continue and recruit more subjects
  • If R1 is not achieved then stop

A
Factorial
B
Group Sequential
C
Two Stage
D
Bayesian

Question Number 5:
Which trial design best describes the diagram below?

A
Factorial
B
Two Stage
C
Randomised Discontinuation
D
Bayesian

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