Intention-to-Treat Analysis
Intention-to-Treat Analysis refers to a principle in clinical trials where participants are analyzed in the groups to which they were originally assigned, regardless of whether they completed the treatment, adhered to the protocol, or crossed over to another group. This approach helps maintain the benefits of randomization and minimizes biases, ensuring that the results are reflective of real-world scenarios.
Examples:
- In a study comparing a new medication to a placebo, if a participant assigned to the medication group stops taking the medication and switches to placebo, their outcome is still analyzed in the medication group.
- A trial assessing a weight-loss program might include participants who drop out or do not attend all sessions, analyzing their weight change based on their initial group assignment.
Cases:
- In a randomized controlled trial of a new cancer treatment, if some patients discontinue the treatment due to side effects but were originally assigned to the treatment group, their outcomes are included in the treatment group analysis.
- A vaccine trial that includes participants who received the vaccine but later developed an illness is analyzed based on their initial random assignment, even if they did not receive the full vaccination regimen.