Technical / White Paper

RACE Act Prompts Pediatric Oncology Trials

Format: PDF file | Document type: Technical / White Paper

RACE Act Prompts Pediatric Oncology Trials

Related categories: Phase I-II, Phase III-IV, Regulatory affairs

Many providers prescribe drugs off-label to pediatric patients, even though there have been few pediatric trials for many of these drugs. In response, The Food & Drug Administration is enacting the Research to Accelerate Cures & Equity (RACE) for Children Act, which amends the Pediatric Research Equity Act. RACE Act will require new drugs intended for adult cancer treatment to be studied in pediatric cancers when the molecular target of the drug is relevant to pediatric oncology. This paper discusses the need for more pediatric research and how the RACE Act applies to precision medicine.

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