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Clinical Trials and Patient Safety

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Questions and Answers

What is the effect of treating 1000 patients with ramipril for 4 years?

It prevents about 150 events in around 70 patients (correct)

It prevents about 100 events in around 35 patients

It prevents about 50 events in around 25 patients

It prevents about 200 events in around 100 patients

What is a disadvantage of using composite end points?

It leads to misattribution of statistically beneficial effects to each component end point (correct)

It increases the sample size and cost

It makes interpretation of results easier

It is not useful in clinical trials

Why do investigators use composite end points in clinical trials?

To avoid reporting individual end points

To decrease the sample size and cost (correct)

To increase the sample size and cost

To make interpretation of results more difficult

What is a potential problem when component end points move in opposite directions?

The composite end point should be abandoned without drawing valid conclusions Signup and view all the answers

What is a surrogate end point?

A laboratory measurement or physical sign that substitutes for how a patient feels, functions, or survives Signup and view all the answers

Why should results for each individual end point be reported?

To allow for a more comprehensive understanding of the trial's outcomes Signup and view all the answers

What is a limitation of composite end points?

It is difficult to interpret them Signup and view all the answers

What is the advantage of using composite end points in terms of sample size?

It decreases the sample size and cost Signup and view all the answers

Why might investigators be interested in multiple outcomes?

Because they want to understand the broad effects of a treatment Signup and view all the answers

What is the problem with 'averaging' the overall effect of composite end points?

It can lead to misleading conclusions Signup and view all the answers