27 Questions
What is the intention-to-treat (ITT) principle in clinical trials?
Patients are analyzed according to the group to which they were assigned, regardless of the treatment received
Why do most statisticians favor the ITT principle in clinical trials?
Because it yields the best properties for the test of the null hypothesis of no treatment difference
What is considered a critical component of the ITT Principle to avoid biases in clinical trials?
Analyzing patients according to the group they were assigned, regardless of adherence to the treatment protocol
According to the E9 document, under what circumstances can randomized patients be excluded from the full analysis set?
If there are a limited number of specific circumstances
Why do federal agencies favor the ITT principle in clinical trials?
Because it focuses on testing treatment policy rather than treatment received
What does 'If randomized, then analyzed' represent in clinical trial methodology?
'Patients should be analyzed according to their group assignment, regardless of adherence'
Under what circumstances can patients who failed to satisfy an entry criterion be excluded from the full analysis set?
If they were provided emergency medications for safety purposes
Why could the placebo group appear more beneficial than the new therapy in an ITT analysis according to the given example?
As a result of providing emergency medications to patients in the placebo group
What can eliminate the problem of misleading results from the ITT analysis, as mentioned in the text?
Using time to treatment failure as the primary endpoint
What is identified as a factor contributing to a patient's failure to complete the intended therapy in the text?
A change of mind
What is preferred as the primary endpoint in situations where ITT analysis could be misleading?
Time to treatment failure
Why does the text state that patients cannot be eliminated from analysis for certain reasons?
To avoid introducing bias into the analysis
What is the intention-to-treat (ITT) principle in clinical trials?
Analyzing patients based on the group they were originally assigned, regardless of the treatment received
Why do federal agencies favor the ITT principle in clinical trials?
To preserve the benefits of randomization and avoid bias
What can eliminate the problem of misleading results from the ITT analysis, as mentioned in the text?
Adhering to the intention-to-treat principle
What is identified as a factor contributing to a patient's failure to complete the intended therapy in the text?
The patient's inability to access the intended therapy
Under what circumstances can patients who failed to satisfy an entry criterion be excluded from the full analysis set?
When their exclusion would not impact the study outcomes
What does 'If randomized, then analyzed' represent in clinical trial methodology?
A commitment to including all randomized patients in the statistical analysis
What type of study design is considered the 'gold standard' for establishing a causal relationship between intervention and outcome?
Randomized controlled trial
What is the name of the analysis that evaluates patients according to the group they were originally assigned to?
Intention-to-treat analysis
What can introduce bias into the study and analysis even in the correct implementation of a valid random allocation sequence?
Incorrect analysis of the data
What can disrupt the prognostic balance afforded by randomization and introduce bias into the study and analysis?
Anything that disrupts the prognostic balance afforded by randomization
What is the most effective way to establish a causal relationship between an intervention and outcome, according to the text?
Randomized controlled trial
When randomization is done correctly, what are the groups balanced with regard to, except for the intervention?
Prognostic variables only
What does an investigator observe in two (or more) groups that are prognostically balanced, with the exception of the intervention?
No difference in outcomes
What is the name of the principle that can lead to a significantly biased assessment of the effectiveness of an intervention if not applied when interpreting results from a randomized trial?
Intention-to-treat principle
What does preserving the integrity of randomization during the implementation of the study and in analysis help guard against, as mentioned in the text?
Bias
Learn about the Intention-to-Treat (ITT) principle and the Treatment Received (TR) principle in clinical trials. Understand the differences and significance of analyzing patients based on assigned groups versus the treatment they actually received.
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