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?

<p>The composite end point should be abandoned without drawing valid conclusions (C)</p> Signup and view all the answers

What is a surrogate end point?

<p>A laboratory measurement or physical sign that substitutes for how a patient feels, functions, or survives (A)</p> Signup and view all the answers

Why should results for each individual end point be reported?

<p>To allow for a more comprehensive understanding of the trial's outcomes (B)</p> Signup and view all the answers

What is a limitation of composite end points?

<p>It is difficult to interpret them (C)</p> Signup and view all the answers

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

<p>It decreases the sample size and cost (C)</p> Signup and view all the answers

Why might investigators be interested in multiple outcomes?

<p>Because they want to understand the broad effects of a treatment (A)</p> Signup and view all the answers

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

<p>It can lead to misleading conclusions (A)</p> Signup and view all the answers

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