CCDM Statistical Analysis 4

Question 1

A non-inferiority trial is designed to show that a new treatment is:

Accepted Answer

Not worse than an active comparator by more than a pre-specified margin

Answer

Non-inferiority trials aim to demonstrate that the new treatment is not worse than the comparator by more than a clinically acceptable margin (delta).

Question 2

When analyzing ordered categorical data (e.g., none/mild/moderate/severe), which test is most appropriate?

Accepted Answer

Wilcoxon rank-sum test (Mann-Whitney U)

Answer

The Wilcoxon rank-sum test is suitable for ordinal data as it uses ranks rather than assuming a normal distribution of continuous values.

Question 3

In a randomized controlled trial, what is the primary role of a Data Safety Monitoring Board (DSMB) regarding interim analyses?

Accepted Answer

To review accumulating data and recommend stopping or continuing the trial

Answer

The DSMB independently reviews interim safety and efficacy data and may recommend early stopping for benefit, harm, or futility.

Question 4

Which approach controls the overall Type I error rate when testing a primary and key secondary endpoint in a hierarchical manner?

Accepted Answer

Fixed-sequence testing, proceeding to the next endpoint only if the prior is significant

Answer

Fixed-sequence (hierarchical) testing preserves the family-wise error rate by requiring each prior test to be significant before proceeding.

Question 5

In logistic regression for a binary clinical endpoint, the exponentiated regression coefficient (e^β) represents:

Accepted Answer

The odds ratio for the outcome per unit increase in the predictor

Answer

Exponentiating the logistic regression coefficient yields the odds ratio, which quantifies the association between the predictor and the binary outcome.

(CCDM) Certified Clinical Data Manager Practice Test

(CCDM) Certified Clinical Data Manager Practice Test

CCDM Statistical Analysis 4