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CASE REPORT

Greater Than Minimal Risk, No Direct Benefit – Bridging Drug Trials and Novel Therapy in Pediatric Populations

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Devan M. Duenas, Benjamin S. Wilfond & Liza-Marie Johnson. (2020) Clearing Muddy Waters: The Need to Reconceptualize Minor Increase over Minimal Risk in Pediatric Rare Disease Research. The American Journal of Bioethics 20:4, pages 8-10.
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Robert M. Nelson. (2020) The Use of Pediatric Extrapolation to Avoid Unnecessary Pediatric Clinical Trials. The American Journal of Bioethics 20:4, pages 114-116.
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Susannah W. Lee & Jessica C. Ginsberg. (2020) Balancing Scientific Progress With Pediatric Protections: No Direct Benefit Now, But Potential Novel Therapy in the Future. The American Journal of Bioethics 20:4, pages 108-110.
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Akshay Sharma & Liza-Marie Johnson. (2020) Bringing Known Drugs to Pediatric Research: Safety, Efficacy, and the Ambiguous Minor Increase in Minimal Risk. The American Journal of Bioethics 20:4, pages 106-108.
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