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Patient Inclusion/Exclusion Criteria in Clinical Trials

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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?

To assess the subjects' compliance with the treatment regimen Signup and view all the answers

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

They are only pertinent to similar women enrolled in the trial Signup and view all the answers

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

To define the characteristics that must be present for enrollment Signup and view all the answers

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

Because they make it difficult to accurately assess the effect of a new treatment Signup and view all the answers

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

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) Signup and view all the answers

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

To allow readers to understand the characteristics of the study population 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?

To include patients who are representative of real patients, whenever possible Signup and view all the answers