OCC Clinical Trials & Evidence-Based Practice Flashcards

Which regulatory body provides oversight and approval for oncology clinical trials and new drug applications in the United States?

Answer: Food and Drug Administration (FDA)

The FDA regulates clinical trials and approves new drugs and biologics for marketing in the United States through the Investigational New Drug (IND) and New Drug Application (NDA) processes.

A nurse researcher is reviewing a meta-analysis on antiemetic efficacy. What does this study design involve?

Answer: Statistical pooling of results from multiple independent studies on the same question

A meta-analysis statistically combines results from multiple independent studies to increase statistical power and provide a more precise estimate of treatment effect.

An oncology patient asks the nurse about expanded access (compassionate use) for an unapproved drug. What is the nurse's BEST response?

Answer: Expanded access may allow seriously ill patients to access investigational drugs outside of a clinical trial; the provider can apply through the FDA

The FDA's expanded access program allows seriously ill patients who lack alternatives to access investigational drugs outside of clinical trials, with the treating physician submitting a request to the FDA.

Which outcome measure is MOST important to patients and is increasingly required in oncology clinical trial reporting?

Answer: Patient-reported outcomes (PROs) including quality of life

Patient-reported outcomes (PROs), including quality of life measures, capture the patient's perspective on treatment burden and benefit, increasingly required by the FDA in oncology trial reporting.

A patient is being screened for a clinical trial and is found to have a liver function test that exceeds the protocol's eligibility criteria. What does the nurse understand about this?

Answer: The patient cannot be enrolled; eligibility criteria are legally binding safety parameters that cannot be waived

Clinical trial eligibility criteria are binding safety and scientific parameters established in the protocol; enrollment of ineligible patients constitutes a protocol deviation or violation.

What is the primary purpose of an Institutional Review Board (IRB) in oncology research?

Answer: To protect the rights and welfare of human research participants by reviewing and approving research protocols

The IRB's primary mandate is to protect human research subjects by independently reviewing protocols for ethical standards, scientific merit, and participant risk/benefit balance.