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Clinical Trials Pediatrics Rare Diseases

Sarepta Trial Protocol Change Could Spur More IRB Referrals To US FDA

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Executive Summary

Investigational review boards might be more inclined to bring pediatric study design issues to FDA’s attention for public review following agency’s quick decision to allow in-dwelling ports for patients in Sarepta’s placebo-controlled ESSENCE trial.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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