Time of Day as an Unmeasured Confounder in Oncology Trials
Somer, J.; Benor, G.; Alpert, A.; Perets, R.; Mannor, S.
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A recent randomized clinical trial in non-small cell lung cancer1 confirms what numerous observational studies have reported - time-of-day (ToD) may dramatically influence treatment outcomes in cancer patients2-9. In this recent trial median overall survival (OS) decreased from 28 months in the early ToD arm to 16.8 months in the late ToD arm. We raise the concern that clinical trial outcomes may be influenced by seemingly minor biases in treatment time across arms. We also suggest that by measuring or randomizing treatment-time in clinical trials, we may identify beneficial ToD-dependent treatments that would otherwise be overlooked.
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