Phase I-IV Clinical Trials Flashcards
7 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Phase I-IV Clinical Trials flashcards as text
In a first-in-human Phase I oncology trial using the 3+3 dose escalation design, the first cohort of 3 patients shows 1 dose-limiting toxicity (DLT). What happens next?
Answer: Enroll 3 additional patients at the same dose level
In the 3+3 design, one DLT in three patients triggers enrollment of three additional patients at the same dose before deciding on escalation or de-escalation.
What is the primary objective of a pharmacokinetic (PK) study conducted as part of a Phase I trial?
Answer: To characterize absorption, distribution, metabolism, and excretion of the drug
Phase I PK studies characterize the ADME profile to understand how the body processes the drug and to inform dosing regimens.
A Phase III randomized controlled trial uses a double-blind design. Who in the trial is kept unaware of treatment assignment?
Answer: Both the subjects and the investigators
In a double-blind design, both subjects and investigators are unaware of treatment assignment to minimize bias in outcome assessment and reporting.
Which of the following best describes an 'adaptive seamless Phase II/III design'?
Answer: A trial that combines Phase II and Phase III patient data in a single analysis
An adaptive seamless Phase II/III design combines both phases into a single trial, and data from both stages may contribute to the final confirmatory analysis.
In the context of Phase IV commitments, what is a 'required post-marketing study' (RPMS)?
Answer: A study the FDA requires as a condition of drug approval
An RPMS is mandated by the FDA as a condition of approval, typically to evaluate a safety concern not fully characterized during pre-approval studies.
A CRA is monitoring a Phase II oncology trial and notices the site has missed collecting mandatory tumor biopsy samples from three subjects. What should the CRA do first?
Answer: Document the deviation and discuss with the site to understand the root cause
The CRA should document the protocol deviation and work with the site to identify the root cause before escalating, following sponsor SOPs.
What term describes the dose level just below the dose that causes unacceptable toxicity in at least 2 of 6 subjects in a 3+3 Phase I design?
Answer: Maximum tolerated dose (MTD)
The MTD is defined as the dose level just below the dose where 2 or more of 6 patients experience a DLT in the 3+3 design.