Patient Inclusion/Exclusion Criteria in Clinical Trials

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Questions and Answers

What is the primary goal of ensuring a factual representation of demographics in a clinical trial?

  • To reduce the cost of the trial
  • To represent the typical patients in which the therapy is intended (correct)
  • To ensure the therapy is effective in all demographics
  • To increase the sample size of the trial

What is the main reason for excluding certain subjects from a clinical trial?

  • To increase the sample size of the trial
  • To prevent the alteration of medication pharmacokinetics and/or pharmacodynamics (correct)
  • To minimize the risk of adverse effects
  • To reduce the study's duration

What is the primary concern when selecting subjects for a clinical trial?

  • Ensuring the subjects are representative of the general population
  • Maximizing the sample size
  • Minimizing the cost of the trial
  • Preventing selection bias (correct)

What is the purpose of a run-in phase in a clinical trial?

<p>To assess the subjects' compliance with the treatment regimen (B)</p> Signup and view all the answers

What is the limitation of the results of the WHI trial?

<p>They are only pertinent to similar women enrolled in the trial (C)</p> Signup and view all the answers

What is the purpose of inclusion criteria in a clinical trial?

<p>To define the characteristics that must be present for enrollment (B)</p> Signup and view all the answers

Why might complex comorbid conditions lead to the exclusion of patients from a trial?

<p>Because they make it difficult to accurately assess the effect of a new treatment (D)</p> Signup and view all the answers

What should be defined in terms of minimal and maximum values in a trial studying hypertension?

<p>Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (C)</p> Signup and view all the answers

Why is it important to include the definitions of inclusion/exclusion criteria in an article reporting study results?

<p>To allow readers to understand the characteristics of the study population (C)</p> Signup and view all the answers

What is the goal when deciding whether to include or exclude patients with complex comorbid conditions from a trial?

<p>To include patients who are representative of real patients, whenever possible (B)</p> Signup and view all the answers

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