#1
What is the purpose of a placebo in a clinical trial?
To provide a baseline for comparison
ExplanationPlacebos help gauge the true effect of a treatment by providing a reference point for comparison.
#2
Which phase of clinical trials typically involves a small group of healthy volunteers?
Phase I
ExplanationPhase I trials primarily assess the safety and dosage range of a treatment in a small group of healthy volunteers.
#3
What is the purpose of blinding in a clinical trial?
To prevent bias in the assessment of outcomes
ExplanationBlinding reduces bias by keeping participants, researchers, or both unaware of which treatment each participant receives.
#4
Which of the following is NOT a common type of randomized clinical trial design?
Observational design
ExplanationObservational studies do not involve random assignment of participants to treatment groups, unlike randomized clinical trials.
#5
What is the purpose of a Phase IV clinical trial?
To evaluate the long-term safety and effectiveness of a treatment
ExplanationPhase IV trials assess a treatment's safety and effectiveness in real-world settings after it has been approved for use.
#6
Which of the following is a characteristic of an open-label clinical trial?
Participants and researchers are aware of the treatment assignment
ExplanationIn open-label trials, both participants and researchers know which treatment is being administered, potentially affecting results.
#7
What is the primary purpose of a crossover design in a clinical trial?
To eliminate carryover effects
ExplanationCrossover designs allow each participant to serve as their own control, reducing variability and increasing study efficiency.
#8
Which statistical test is commonly used to compare means between two groups in a clinical trial?
Student's t-test
ExplanationThe Student's t-test assesses whether the means of two groups are statistically different from each other.
#9
What does the acronym 'RCT' stand for in the context of clinical trials?
Randomized Controlled Trial
ExplanationRCTs are experiments where participants are randomly assigned to different treatment groups to assess the efficacy and safety of interventions.
#10
Which of the following is a potential limitation of a double-blind clinical trial?
It can be challenging to maintain blinding throughout the trial
ExplanationMaintaining blinding in double-blind trials can be difficult, potentially leading to unblinding and bias.
#11
What is the purpose of a dose-escalation study in clinical research?
To evaluate the safety and tolerability of increasing doses of a treatment
ExplanationDose-escalation studies assess the safety and tolerability of gradually increasing doses of a treatment.
#12
In a non-inferiority clinical trial, what does it mean if the lower bound of the confidence interval for the treatment difference falls within the predefined margin?
The new treatment is deemed non-inferior to the active comparator
ExplanationIf the lower bound of the confidence interval falls within a predefined margin, it suggests the new treatment is not worse than the active comparator by more than the margin.
#13
What is the purpose of an intention-to-treat analysis in a clinical trial?
To analyze data based on the treatment actually received
ExplanationIntention-to-treat analysis preserves the benefits of randomization by analyzing participants according to their assigned treatment group, regardless of adherence.
#14
What is the purpose of a superiority trial in clinical research?
To demonstrate that a new treatment is superior to an existing treatment
ExplanationSuperiority trials aim to show that one treatment is better than another, often a new treatment compared to the standard of care.
#15
What is the primary purpose of adaptive clinical trial designs?
To allow for modifications to the trial protocol based on accumulating data
ExplanationAdaptive designs permit adjustments to the trial protocol based on interim data, optimizing efficiency and flexibility.
#16
Which of the following is a limitation of using historical controls in a clinical trial?
Historical controls may not adequately represent the current patient population
ExplanationHistorical controls may introduce biases due to differences in patient characteristics, treatments, or outcomes over time.
#17
What is the purpose of a non-inferiority trial in clinical research?
To demonstrate that a new treatment is non-inferior to an active comparator
ExplanationNon-inferiority trials aim to show that a new treatment is not worse than an active comparator by more than a predefined margin.