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Eligibility criteria in pediatric oncology Phase I and II clinical trials: Analysis and recommendations for standardization from the Innovative Therapies for Children and Adolescents with Cancer (ITCC) Consortium
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DOI：10.1016/j.ejca.2026.116830.png)
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Abstract
En 中文
• The number of eligibility criteria increased significantly over time. • For 93% of common or relevant inclusion criteria, a documented rationale was missing in the protocol. • There is considerable heterogeneity in the thresholds for organ function and washout periods. • Redundant eligibility criteria are widespread, with a 69% overlap in inclusion and exclusion criteria.
Keywords:
Eligibility criteria
Pediatric oncology
Clinical trials
Standardization
Protocol analysis
Journal
IF:
7.1
Papers:
2.6W
Citations:
3.8W
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