Randomized trial evaluates the impact of renal eligibility criteria on drug safety in oncology, suggesting improved assessments may mitigate toxicities.
The selection of appropriate eligibility criteria is a cornerstone of early phase clinical trial design. The objective assessment of renal function is especially critical, as a significant proportion of investigational agents undergo renal elimination. Impaired renal function can result in systemic drug accumulation and dose-dependent toxicities. In early phase trials, where the safety profile of oncology drug products remains largely uncertain, satisfactory renal function plays a key role in minimizing the risk of toxicities.
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Tan et al. (2026) studied this question.
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