Intention to treat - who should use ITT?
1993
Understanding Intention to Treat in Clinical Trials
Editorial
Evidence: moderate
Author Information
Author(s): J.A. Lewis, D. Machin
Primary Institution: University of Kent; MRC Cancer Trials Office
Conclusion
Intention to treat (ITT) is a valuable strategy for analyzing clinical trials, particularly those with hard endpoints like mortality, but its application can be problematic in other types of studies.
Supporting Evidence
- ITT is endorsed in regulatory guidelines in Europe and the USA.
- Studies show that ITT can lead to more robust conclusions in trials.
- Critics argue that ITT may not be suitable for all types of clinical trials.
Takeaway
Intention to treat means including all patients in a study, even if they didn't follow the rules perfectly, to get a clearer picture of how a treatment works in real life.
Potential Biases
There is a risk of bias if entry criteria violations are not properly managed.
Limitations
ITT may mislead in equivalence trials and does not account for all types of data loss effectively.
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