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
Which of the following best describes the Hawthorne effect in clinical research?
Answer: Participants improve outcomes simply because they know they are being observed
The Hawthorne effect refers to the tendency for study participants to modify their behavior merely because they are being observed, potentially inflating outcomes.
In clinical trial statistics, a p-value of 0.03 means:
Answer: There is a 3% probability of observing results at least as extreme as those obtained, assuming the null hypothesis is true
A p-value quantifies the probability of obtaining the observed (or more extreme) results under the null hypothesis; it does not directly state the probability that the null hypothesis is true.
A meta-analysis that pools data from individual patient records rather than published summary statistics is called a:
Answer: Individual patient data (IPD) meta-analysis
IPD meta-analyses use raw participant-level data from each included study, allowing more flexible and precise analyses than aggregate-data methods.
Which method is used to account for imbalanced confounders between treatment groups in an observational study?
Answer: Propensity score analysis
Propensity score methods (matching, weighting, or stratification) balance measured confounders between groups in observational studies to reduce confounding.
In a dose-response relationship, what does a monotonic response pattern indicate?
Answer: The effect consistently increases or decreases with increasing dose without reversals
A monotonic dose-response means the effect changes in one direction (either always increasing or always decreasing) as dose increases.
The primary advantage of using a stratified randomization scheme in a clinical trial is to:
Answer: Ensure balance of key prognostic factors across treatment groups
Stratified randomization ensures that important prognostic variables are evenly distributed between treatment arms, reducing the risk of chance imbalance.
A Phase II basket trial enrolls patients with different tumor types that share the same molecular alteration. The primary rationale is to:
Answer: Test whether a targeted therapy works across tumor types sharing a common biomarker
Basket trials test a single targeted agent in multiple tumor types defined by a shared molecular target, leveraging the biomarker rather than tumor histology.