Over 90% of the rules that keep kids out of cancer trials are basically just made up and have no real science behind them.
March 30, 2026
Original Paper
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
SSRN · 6481533
The Takeaway
By analyzing 48 pediatric oncology trials, researchers found that while protocols are getting more complex and restrictive, only 7% of the criteria for excluding patients were backed by scientific evidence. This suggests that thousands of sick children are barred from life-saving experimental treatments based on arbitrary administrative 'copy-pasting.'
From the abstract
IntroductionEligibility criteria safeguard trial integrity and safety, yet restrictive requirements frequently limit patient access and generalizability. While initiatives exist to simplify criteria in adult populations, evidence supporting their use and justification within pediatric oncology remains undefined.MethodsSixty-four protocols from 48 ITCC phase I–II trials (2011–2020) were evaluated. Protocol, literature analysis, and regulatory standards review was performed. Eligibility criteria w