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