CTA Biostatistics & Study Design Flashcards
6 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CTA Biostatistics & Study Design flashcards as text
What is a primary endpoint in a clinical trial?
Answer: The main outcome measure used to assess the treatment's effect
The primary endpoint is the pre-specified main outcome measure that the trial is powered to evaluate and that drives the key efficacy conclusion.
What distinguishes a surrogate endpoint from a clinical endpoint in trial design?
Answer: Surrogate endpoints measure a biomarker expected to predict clinical benefit rather than direct patient outcomes
Surrogate endpoints, such as tumor shrinkage or biomarker levels, are used as proxies for clinical outcomes like survival when direct measurement would require too long a follow-up.
What is a crossover study design?
Answer: Each participant receives both treatments in a random sequence with a washout period between them
In a crossover design, each participant acts as their own control by receiving both the treatment and comparator in a randomized order, separated by a washout period.
What is the purpose of a washout period in a crossover clinical trial?
Answer: To allow the drug from the first treatment period to clear before the next treatment begins
A washout period allows any residual effects or drug concentrations from the prior treatment to dissipate before the participant begins the next treatment period.
What does an adaptive trial design allow researchers to do?
Answer: Modify pre-specified trial aspects (e.g., sample size, dose) based on interim data while maintaining validity
Adaptive designs allow pre-specified modifications to trial elements based on accumulating interim data, improving efficiency without compromising statistical integrity.
What is the role of a Data Safety Monitoring Board (DSMB) in a clinical trial?
Answer: To independently review accumulating safety and efficacy data and recommend continuation, modification, or stopping the trial
A DSMB is an independent group that reviews unblinded interim data to protect participant safety and make recommendations about continuing, modifying, or halting the trial.