451218
Description
Question 1
Question
Heterogeneous patient populations in clinical studies are a group of patients with a lot of similarities.
Answer
- True
- False
Question 2
Question
The Abstract section is the best place to find the answer to the question Why was this study conducted?
Answer
- True
- False
Question 3
Question
Who is ultimately responsible for legal issues that arise from the off-label or nonindicated use of a pharmaceutical?
Answer
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the company that manufactured the product, regardless of whether or not their claims were supported by scientific evidence
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the FDA for approving the dissemination of information regarding these off-label uses
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the pharmaceutical sales representatives who educated the physicians on the product’s off-label uses
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the physicians who prescribed or recommended the product to their patients
Question 4
Question
What is one of the differences between Phase I and Phase II clinical trials?
Answer
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Phase I trials are larger than Phase II trials.
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Phase I trials are on animals, whereas Phase II trials are on humans.
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Phase I trials involve subjects who do not suffer from the product's target disease or symptoms.
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Phase I trials primarily involve terminally ill patients and prisoners, whereas Phase II trials are conducted on healthy volunteers.
Question 5
Question
Which of the following distinguishes Phase III from Phase II trials?
Answer
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Phase III is a post-approval phase.
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Phase III trials are typically conducted at multiple sites.
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Phase III trials involve fewer subjects.
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Phase III trials involve safety and efficacy.
Question 6
Question
What is one way in which Phase IV trials differ from the other three phases of clinical trials (i.e., Phase I, Phase II, and Phase III)?
Answer
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Phase IV is conducted after the drug has already received FDA approval.
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Phase IV is the only phase in which studies are not double-blinded.
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Phase IV studies cannot be published.
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Phase IV studies cannot be used is medical sales representatives' sales calls.
Question 7
Question
What would most likely be included in the Introduction section of a clinical paper on a new product?
Answer
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a description of how the subjects were selected
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an overview of comparable products
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data on how the subjects improved after using the new product
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the authors' opinions on how this study should affect future research on the topic
Question 8
Question
What would most likely be included in the Methods section of a clinical paper on a new IOL?
Answer
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a table summarizing subjects' adverse reactions to the new IOL
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background information on the effectiveness of other types of IOLs
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everything that another researcher would need to know in order to replicate the experiment
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the authors' theories about why this device is more effective than other IOLs
Question 9
Question
Which of the following statements does NOT accurately describe a difference between statistical significance and clinical importance?
Answer
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A study must be statistically significant in order to be clinically important.
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It is possible for the results to be statistically insignificant, but actually have high clinical importance.
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Many studies’ results are statistically significant without being clinically important.
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The authors of clinical papers are trained and encouraged to emphasize statistical significance.
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