Clinical Research & Study Design Flashcards
7 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Clinical Research & Study Design flashcards as text
In a pragmatic clinical trial, the study conditions are designed to:
Answer: Reflect real-world clinical practice and diverse patient populations
Pragmatic trials prioritize external validity by enrolling broad populations and allowing routine clinical flexibility, contrasting with explanatory (efficacy) trials.
Which of the following is a key feature distinguishing a non-inferiority trial from a superiority trial?
Answer: Non-inferiority trials define a pre-specified margin within which the new treatment must fall
A non-inferiority margin (delta) defines the maximum acceptable difference; the new treatment must be within this margin of the active control to be declared non-inferior.
Confounding in observational research occurs when:
Answer: A third variable is associated with both the exposure and the outcome
A confounder is associated with both the exposure of interest and the outcome, creating a spurious or distorted association between them.
A prospective cohort study differs from a retrospective cohort study primarily in that:
Answer: Exposure and outcome data are collected forward in time from enrollment
In a prospective cohort study, researchers define and follow participants forward in time, collecting exposure and outcome data as they occur.
Which type of bias occurs when study participants who drop out differ systematically from those who complete the study?
Answer: Attrition (loss-to-follow-up) bias
Attrition bias results when dropout is related to the treatment or outcome, making completers unrepresentative of the original sample.
In a factorial trial design, multiple interventions are tested simultaneously primarily to:
Answer: Assess each factor's effect and potential interactions efficiently
Factorial designs allow researchers to evaluate two or more independent treatments and their interactions within a single trial, improving efficiency.
According to the CONSORT statement, what must be reported in a randomized trial publication to ensure transparency?
Answer: Details of randomization, blinding, participant flow, and all pre-specified outcomes
CONSORT (Consolidated Standards of Reporting Trials) requires comprehensive reporting of trial design, conduct, and analysis to minimize reporting bias.