10 Questions
What is the effect of treating 1000 patients with ramipril for 4 years?
It prevents about 150 events in around 70 patients
What is a disadvantage of using composite end points?
It leads to misattribution of statistically beneficial effects to each component end point
Why do investigators use composite end points in clinical trials?
To decrease the sample size and cost
What is a potential problem when component end points move in opposite directions?
The composite end point should be abandoned without drawing valid conclusions
What is a surrogate end point?
A laboratory measurement or physical sign that substitutes for how a patient feels, functions, or survives
Why should results for each individual end point be reported?
To allow for a more comprehensive understanding of the trial's outcomes
What is a limitation of composite end points?
It is difficult to interpret them
What is the advantage of using composite end points in terms of sample size?
It decreases the sample size and cost
Why might investigators be interested in multiple outcomes?
Because they want to understand the broad effects of a treatment
What is the problem with 'averaging' the overall effect of composite end points?
It can lead to misleading conclusions
This quiz covers the primary and secondary aims of clinical trials, ensuring patient safety and data integrity in investigational medicinal product trials.
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