AOCNP Clinical Trials and Evidence-Based Oncology Practice

Question 1

In a Phase I clinical trial for a new oncology drug, the primary objective is to determine:

Accepted Answer

Maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs)

Answer

Efficacy and overall response rate

Answer

Long-term survival benefit compared to standard of care

Answer

Quality of life improvements over existing therapy

Question 2

The principle of equipoise in clinical trial ethics means:

Accepted Answer

There is genuine uncertainty about which treatment arm is superior, justifying randomization

Answer

All participants must receive the same treatment

Answer

Participants must be equally distributed across age groups

Answer

The trial must include equal numbers of males and females

Question 3

Informed consent for clinical trial participation must include which elements specific to research, beyond standard clinical care consent?

Accepted Answer

Voluntary nature of participation, right to withdraw, foreseeable risks/benefits, and availability of alternative treatments

Answer

Only the principal investigator's contact information

Answer

Guarantee of treatment benefit based on Phase I data

Answer

Insurance billing codes for the experimental intervention

Question 4

A randomized controlled trial (RCT) in oncology is considered the gold standard for evidence because:

Accepted Answer

Randomization controls for confounding variables and reduces selection bias, allowing causal inference

Answer

It is faster and less expensive than observational studies

Answer

All patients receive the experimental treatment

Answer

RCTs always include placebo control arms

Question 5

Which term describes a trial design where a new agent is tested across multiple cancer types based on a shared molecular target (biomarker) rather than tumor histology?

Accepted Answer

Basket trial

Answer

Umbrella trial

Answer

Platform trial

Answer

Crossover trial

Question 6

The ONCO NP role in clinical trials includes which key responsibility?

Accepted Answer

Ensuring protocol adherence, obtaining informed consent, monitoring for adverse events, and educating patients about trial participation

Answer

Designing the statistical analysis plan for the trial

Answer

Determining eligibility criteria independently without PI oversight

Answer

Unblinding participants when they request it