AOCNP Clinical Trials and Evidence-Based Oncology Practice 5

Question 1

Which endpoint is considered most rigorous for demonstrating clinical benefit in oncology trials submitted for FDA approval?

Accepted Answer

Overall survival (OS)

Answer

Overall survival is the gold-standard endpoint because it directly measures patient longevity and is unambiguous.

Question 2

A phase I dose-escalation trial uses a 3+3 design. A dose level has 1 DLT in the first 3 patients. What happens next?

Accepted Answer

Three additional patients are enrolled at the same dose level

Answer

In the 3+3 design, one DLT in the first cohort triggers enrollment of 3 more patients at the same dose before escalation decisions are made.

Question 3

Which regulatory pathway allows the FDA to approve a cancer drug based on a surrogate endpoint reasonably likely to predict clinical benefit?

Accepted Answer

Accelerated approval

Answer

Accelerated approval allows use of surrogate or intermediate endpoints (e.g., ORR, PFS) when likely to predict clinical benefit, with confirmatory trials required.

Question 4

An NP notes that a published RCT has a high attrition rate with differential dropout between arms. Which type of bias is most concerning?

Accepted Answer

Attrition bias

Answer

Attrition bias occurs when differential or substantial loss to follow-up between arms distorts the comparison of outcomes.

Question 5

What does the Number Needed to Treat (NNT) represent in oncology evidence appraisal?

Accepted Answer

The number of patients who must be treated to prevent one additional adverse outcome

Answer

NNT is the inverse of absolute risk reduction and indicates how many patients must receive treatment for one to benefit.

AOCNP - Advanced Oncology Certified Nurse Practitioner Practice Test

AOCNP - Advanced Oncology Certified Nurse Practitioner Practice Test

AOCNP Clinical Trials and Evidence-Based Oncology Practice 5