Oncology principles for design, analysis & reporting of phase 3 randomised clinical trials” recently The Lancet Oncology paper.
Some RCTs have disclosed various types of bias limiting their interpretation.
DOI: 10.1016/S1470-2045(24)00451-0
Continue reading in comments
Some RCTs have disclosed various types of bias limiting their interpretation.
DOI: 10.1016/S1470-2045(24)00451-0
Continue reading in comments
Comments
1. Control treatments should represent best current standard of care
2. Preferred primary endpoint: overall survival (OS)/ surrogate
3. Provide absolute measure of benefit (e.g. difference between groups in median OS times, proportion surviving until moment T)
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5. Toxicity described objectively
6. Design ensures to show/rule out clinically meaningful differences in outcomes (no only statistical significance)
7. Censoring should be detailed, sensitivity analyses