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Weekly GCP Challenge

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Challenge: Sample Sizing Clinical Trials

Question Number 1:

Which of the following could potentially reduce the sample size requirement when designing a clinical trial?

  1. changing from a parallel group trial to a cross over trial
  2. making the entry criteria for the trial less variable
  3. increasing the power level
  4. changing the significance level from 5% to 1%
A
4 only
B
2 and 3 only
C
1 and 4 only
D
1 and 2 only

Question Number 2:

If the sample size calculations suggest a requirement for 1000 patients to complete the trial and the drop out rate is expected to be around 20%, how many patients would you recruit into the trial?

A
1200
B
1250
C
1300
D
1350

Question Number 3:

Which of the following is true about a trial that is designed with 80% power?

 

 

A
The chance of the trial being a success is 80%
B
There is a 20% chance that even if all the assumptions made during sample sizing are correct the trial will fail to give a positive result
C
There is a 20% chance the trial will not be a success
D
The trial will demonstrate with 80% certainty that the test product is effective

Question Number 4:

Which Guideline provides guidance on the re-assessment of the original assumptions of the power and sample size, including the test below:

"In long term trials there will usually be an opportunity to check the assumptions which underlay the original design and sample size calculations. This may be particularly important if the trial specifications have been made on preliminary and/or uncertain information."

A
ICH E6 - GCP
B
ICH E8 - General Consideration of Clinical Trials
C
ICH E9 - Statistical Principles in Clinical Trials
D
ICH E10 - Choice of Control Groups

Question Number 5:

When sample sizing some oncology trials, for example those using time to death as an endpoint, which of the following additional factors need to be considered to determine the sample size?

  1. expected duration of recruitment
  2. expected rate of recruitment per month
  3. expected rate of the event (e.g. death) occuring
  4. minimum length of follow up for patients
A
2 and 4 only
B
3 and 4 only
C
1 and 3 only
D
All of them

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