AOCNP Clinical Trials and Evidence-Based Oncology Practice 4 — Questions and Answers
Question 1: A patient asks about joining a basket trial. Which best describes this trial design?
- Enrolls patients with the same tumor histology regardless of molecular profile
- Enrolls patients with the same molecular alteration across multiple tumor types (Correct answer)
- Randomizes patients between two standard chemotherapy regimens
- Tests a single drug only in patients with early-stage cancers
Correct answer: Enrolls patients with the same molecular alteration across multiple tumor types
Basket trials enroll patients based on a shared molecular alteration (e.g., BRAF V600E) regardless of tumor histology.
Question 2: Which statistical concept describes the probability of correctly detecting a true treatment effect in a clinical trial?
- Type I error
- Confidence interval width
- Statistical power (Correct answer)
- P-value threshold
Correct answer: Statistical power
Statistical power (1 − β) is the probability that a trial will detect a true treatment effect when one exists.
Question 3: An oncology NP reviews a study reporting a hazard ratio (HR) of 0.72 with 95% CI 0.58–0.89 for overall survival. How should this be interpreted?
- The treatment increases the risk of death by 28%
- The treatment reduces the risk of death by 28% and the result is statistically significant (Correct answer)
- The CI crossing 1.0 means the result is not significant
- The treatment has no effect because HR is less than 1
Correct answer: The treatment reduces the risk of death by 28% and the result is statistically significant
HR < 1 favors the treatment arm, and a 95% CI that does not cross 1.0 indicates statistical significance.
Question 4: Which adaptive trial design feature allows modification of the randomization ratio during an ongoing trial based on interim results?
- Crossover design
- Response-adaptive randomization (Correct answer)
- Factorial design
- Parallel-group stratification
Correct answer: Response-adaptive randomization
Response-adaptive randomization dynamically shifts allocation probability toward the better-performing arm as interim data accumulate.
Question 5: A clinical trial uses a 2×2 factorial design. What is the primary advantage of this design?
- It eliminates the need for a placebo control
- It allows simultaneous testing of two independent interventions in one trial (Correct answer)
- It guarantees blinding of all participants
- It requires fewer statistical analyses than parallel-group designs
Correct answer: It allows simultaneous testing of two independent interventions in one trial
Factorial designs test two or more interventions simultaneously, increasing efficiency by answering multiple questions with one sample.
Question 6: When appraising a systematic review, which tool is most appropriate for assessing risk of bias in individual randomized controlled trials included in the review?
- CONSORT checklist
- Cochrane RoB 2 tool (Correct answer)
- GRADE framework
- PRISMA statement
Correct answer: Cochrane RoB 2 tool
The Cochrane Risk of Bias 2 (RoB 2) tool is the standard instrument for evaluating bias in randomized controlled trials.
Question 7: A patient enrolled in a clinical trial withdraws consent. What is the correct action regarding their previously collected data?
- All previously collected data must be immediately destroyed
- Previously collected data may generally be retained and used per the original consent terms (Correct answer)
- The patient's data must be excluded from all analyses
- The IRB must be notified and all data frozen pending review
Correct answer: Previously collected data may generally be retained and used per the original consent terms
Under most IRB protocols and federal regulations, data collected prior to withdrawal can be retained and analyzed unless the patient specifically requests destruction.
AOCNP Clinical Trials and Evidence-Based Oncology Practice 4
A patient asks about joining a basket trial.
Which best describes this trial design?