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Pediatric Trials for Cancer Therapies With Targets Potentially Relevant to Pediatric Cancers.
Journal of the National Cancer Institute ( IF 10.3 ) Pub Date : 2019-10-29 , DOI: 10.1093/jnci/djz207
Thomas J Hwang 1 , Liat Orenstein 1 , Steven G DuBois 2, 3 , Katherine A Janeway 2, 3 , Florence T Bourgeois 1, 3
Affiliation  

The Research to Accelerate Cures and Equity (RACE) for Children Act was enacted in 2017 to authorize the US Food and Drug Administration (FDA) to require pediatric studies for new cancer drugs that have a molecular target relevant to the growth or progression of a pediatric cancer. To assess the possible scope of this new policy, we examined all 78 adult cancer drugs approved by the FDA from 2007 to 2017. Only 17 (21.8%) drugs received any pediatric labeling information. Based on the FDA’s Pediatric Molecular Target List, we found that the RACE Act could have increased the proportion of cancer drugs potentially subject to pediatric study requirements from 0% to 78.2%. However, the actual effect of the legislation will depend on how often regulators require pediatric trials and on timely completion of such trials.

中文翻译:

针对与儿童癌症潜在相关的靶标的癌症治疗的儿童试验。

《儿童加速治愈和公平研究(RACE)法案》于2017年颁布,授权美国食品和药物管理局(FDA)要求对具有与小儿生长或进展相关的分子靶标的新型抗癌药物进行小儿研究癌症。为了评估这项新政策的可能范围,我们检查了2007年至2017年FDA批准的所有78种成人抗癌药物。只有17种(21.8%)药物获得了任何儿科标签信息。根据FDA的《儿科分子目标清单》,我们发现RACE法案可能将可能受到儿科研究要求的癌症药物比例从0%提高到78.2%。但是,该立法的实际效果将取决于监管机构要求进行儿科试验的频率以及此类试验的及时完成。
更新日期:2020-04-17
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