Clinical Trials and Evidence-Based Oncology Practice Flashcards

Which type of systematic review and meta-analysis evidence is considered the highest level in the evidence hierarchy for oncology treatment decisions?

Answer: Systematic review/meta-analysis of multiple high-quality RCTs (Level I evidence)

In the evidence hierarchy (Level I–V), Level I evidence represents systematic reviews and meta-analyses that pool results from multiple well-designed RCTs using rigorous methodology. This provides the most reliable estimate of treatment effects by maximizing statistical power and controlling for bias across studies.

A Phase III oncology trial reports a hazard ratio (HR) of 0.72 (95% CI: 0.58–0.89) for progression-free survival. How should this result be interpreted?

Answer: The experimental arm reduces the risk of progression by 28% compared to control, with a statistically significant result

An HR of 0.72 means the experimental treatment reduces the instantaneous risk of progression by 28% compared to control (1 - 0.72 = 0.28). The 95% confidence interval (0.58–0.89) does not cross 1.0, confirming statistical significance. HR <1 always favors the experimental arm for time-to-event outcomes.

Protocol deviation vs. protocol violation in clinical trials: which is more serious and requires immediate reporting?

Answer: Protocol violation — deviations that affect participant safety, data integrity, or rights, requiring immediate IRB and sponsor reporting

Protocol violations (also called serious deviations) are departures that have potential to affect participant safety, rights, or welfare, or to significantly impact data integrity or trial conduct. These require prompt reporting to the IRB/IEC, sponsor, and regulatory authorities. Minor deviations without impact are documented but have lower reporting urgency.

Which regulatory body requires submission of an Investigational New Drug (IND) application before clinical trials of a new agent can begin in the United States?

Answer: Food and Drug Administration (FDA)

The FDA requires an IND application before a new drug or biological product can be administered to humans in the U.S. The IND contains preclinical data, manufacturing information, clinical protocols, and investigator qualifications. FDA has 30 days to review; if no clinical hold is placed, the trial may proceed.

Which oncology clinical trial design allows all patients to eventually receive the experimental treatment, eliminating the ethical concern of permanent denial of a potentially beneficial therapy?

Answer: Crossover trial design

In crossover trials, patients receive both the experimental and control treatment sequentially (typically in randomized order with a washout period). This allows all participants to receive the potentially beneficial experimental therapy at some point, addressing the ethical concern of withholding potentially effective treatment and improving statistical efficiency.

The ONCO NP conducting research must obtain IRB approval before initiating a study because the IRB serves which primary function?

Answer: Protecting the rights, safety, and welfare of human research participants

Institutional Review Boards (IRBs) operate under the Belmont Report principles (respect for persons, beneficence, justice) and federal regulations (45 CFR 46, 21 CFR 56) to review and approve research protocols involving human subjects. Their primary mandate is protecting participants from undue risk, coercion, and violations of privacy/autonomy.