Clinical Trials Flashcards
7 cards from real CNPR 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 Trials flashcards as text
What is a 'surrogate endpoint' in a clinical trial?
Answer: A biomarker or lab measure used as a substitute for a clinically meaningful outcome
A surrogate endpoint is a biomarker (e.g., blood pressure, viral load) believed to predict a clinical outcome, used to expedite drug evaluation.
What is the key difference between efficacy and effectiveness in drug evaluation?
Answer: Efficacy is measured under ideal controlled conditions; effectiveness is measured in real-world settings
Efficacy refers to how well a drug performs under controlled trial conditions, while effectiveness reflects performance in real-world clinical practice.
Which FDA designation is granted to drugs that treat serious conditions and fill an unmet medical need, allowing faster approval?
Answer: Breakthrough Therapy Designation
Breakthrough Therapy Designation allows intensive FDA guidance and expedited development for drugs that show substantial improvement over existing therapies for serious conditions.
What is the purpose of stratified randomization in a clinical trial?
Answer: To ensure balance of key prognostic factors across treatment groups
Stratified randomization ensures important prognostic variables (e.g., age, disease severity) are balanced across treatment groups, reducing confounding.
What does 'crossover design' mean in a clinical trial?
Answer: Participants receive both the active treatment and control in sequential periods
In a crossover design, each participant serves as their own control by receiving both treatments in different time periods, increasing statistical efficiency.
Which analysis approach in clinical trials includes data from all randomized participants regardless of protocol adherence?
Answer: Intention-to-treat analysis
Intention-to-treat (ITT) analysis includes all randomized participants in their originally assigned group, preserving the benefits of randomization and reflecting real-world conditions.
What is a Phase IV clinical trial also known as?
Answer: Post-marketing surveillance study
Phase IV trials, also called post-marketing surveillance studies, monitor a drug's long-term safety and effectiveness after FDA approval in the general population.