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

Uri Ilan

doi:10.1016/j.ejca.2026.116830

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

2026-05-25

0

PRE

AI

U

Uri Ilan

A

Alba Rubio‐San‐Simón

N

Natasha van Eijkelenburg

C

Cormac Owens

A

Aviva Kraus

L

Lucas Moreno

F

Fernando Carceller

C

Carole Lecinse

L

Leona Knox

N

Nicole Scobie

B

Birgit Geoerger

C

C. Michel Zwaan

P

PorsKlaus (Pamela Kearns)

F

Francisco Bautista *

DOI：10.1016/j.ejca.2026.116830

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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

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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