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 Phase I dose-escalation study, what is the primary purpose of a 'sentinel dosing' strategy?
Answer: To administer the dose to one or two subjects first before dosing the rest of the cohort
Sentinel dosing involves treating one or two subjects before the remainder of a cohort to allow early safety monitoring before wider exposure.
A Phase II trial is designed with a Simon two-stage design. What is the main advantage of this design?
Answer: It allows early termination for futility after the first stage
The Simon two-stage design allows early stopping if the drug shows insufficient activity in stage one, conserving resources and protecting subjects.
Which regulatory submission is typically required before initiating a Phase I clinical trial in the United States?
Answer: Investigational New Drug Application (IND)
An IND must be submitted to and allowed by the FDA before a sponsor can begin human clinical testing of an investigational drug.
In Phase III trials, what does the term 'superiority trial' mean?
Answer: The trial tests whether a new drug is better than placebo or active comparator
A superiority trial is designed to demonstrate that the new treatment is statistically better than the comparator or placebo.
During a Phase IV post-marketing study, a CRA identifies a serious unexpected adverse drug reaction in multiple subjects. What is the most appropriate immediate action?
Answer: Notify the sponsor's pharmacovigilance team immediately per protocol
Serious unexpected adverse reactions must be reported to the sponsor's pharmacovigilance team immediately so expedited regulatory reporting can occur.
What distinguishes a Phase IIb trial from a Phase IIa trial?
Answer: Phase IIa assesses proof-of-concept while Phase IIb focuses on dose-finding
Phase IIa typically explores proof-of-concept and initial efficacy signals, while Phase IIb is a more rigorous dose-ranging study to select the optimal dose for Phase III.
A sponsor wants to run a combined Phase I/II trial. Which ICH guideline is most relevant to the design of such a seamless adaptive trial?
Answer: ICH E8(R1) — General Considerations for Clinical Studies
ICH E8(R1) provides general considerations for the design, conduct, and reporting of clinical studies including adaptive and seamless designs.