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Rethinking Clinical Trial Design to Include Patients With Brain Metastases
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Fusion42 · 23 August 2026 · Fusion42 review
Experts argue for ethical inclusion of patients with brain metastases in early-phase clinical trials to generate direct evidence of CNS drug efficacy, moving beyond extrapolated data from trials excluding these patients. This shift aligns with initiatives like the FDA's Project Optimus to ensure treatments are effective in the brain at tolerable doses.
This Wire brief sits within Fusion42's coverage of Health.
◆ ◆ The Wire takeaway
You face a new regulatory push to include patients with brain metastases early in oncology trials, opening access but requiring demonstration of CNS drug activity. Adjust trial designs now to capture direct CNS efficacy data or risk exclusion from the evolving standard.
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1 source · 23 Aug 2026
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