• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

Accelerating the Global Development of Pediatric Cancer Drugs: A Call to Coordinate the Submissions of Pediatric Investigation Plans and Pediatric Study Plans to the European Medicines Agency and US Food and Drug Administration.

作者信息

Reaman Gregory, Karres Dominik, Ligas Franca, Lesa Giovanni, Casey Denise, Ehrlich Lori, Norga Koen, Pazdur Richard

机构信息

Oncology Center of Excellence, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD.

Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.

出版信息

J Clin Oncol. 2020 Dec 20;38(36):4227-4230. doi: 10.1200/JCO.20.02152. Epub 2020 Sep 18.

DOI:10.1200/JCO.20.02152
PMID:32946356
Abstract
摘要

相似文献

1
Accelerating the Global Development of Pediatric Cancer Drugs: A Call to Coordinate the Submissions of Pediatric Investigation Plans and Pediatric Study Plans to the European Medicines Agency and US Food and Drug Administration.加速儿科癌症药物的全球开发：呼吁协调向欧洲药品管理局和美国食品药品监督管理局提交儿科研究计划和儿科研究方案
J Clin Oncol. 2020 Dec 20;38(36):4227-4230. doi: 10.1200/JCO.20.02152. Epub 2020 Sep 18.
2
The Meanings of "Pediatric Drug Development".“儿科药物研发”的含义
Ther Innov Regul Sci. 2019 Nov;53(6):767-774. doi: 10.1177/2168479018812060. Epub 2018 Dec 9.
3
Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans.发表的《儿科肿瘤学药物开发共同评论》：优化儿科开发计划全球监管协调的又一步。
Ther Innov Regul Sci. 2021 Nov;55(6):1109-1110. doi: 10.1007/s43441-021-00339-z. Epub 2021 Sep 8.
4
Model-Informed Drug Development: A Regulatory Perspective on Progress.模型引导的药物研发：监管视角下的进展
Clin Pharmacol Ther. 2019 Jul;106(1):91-93. doi: 10.1002/cpt.1475. Epub 2019 Jun 4.
5
A Call for Objective Dose Selection to Increase Success in Pediatric Clinical Trials: A Perspective From NICHD and NIMH Program Staff.呼吁进行客观剂量选择以提高儿科临床试验成功率：来自美国国立儿童健康与人类发展研究所和美国国立精神卫生研究所项目工作人员的观点
J Clin Pharmacol. 2021 Jun;61 Suppl 1:S9-S12. doi: 10.1002/jcph.1849.
6
Paediatric Strategy Forum for medicinal product development for acute myeloid leukaemia in children and adolescents: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.儿科药物研发策略论坛：急性髓系白血病儿童和青少年药物研发：与欧洲药品管理局合作，美国食品药品监督管理局参与，简称 ACCELERATE。
Eur J Cancer. 2020 Sep;136:116-129. doi: 10.1016/j.ejca.2020.04.038. Epub 2020 Jul 17.
7
Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?欧洲药品管理局、美国食品和药物管理局及其他国际监管机构是否在相互沟通？
Clin Pharmacol Ther. 2020 Mar;107(3):507-513. doi: 10.1002/cpt.1617. Epub 2019 Oct 24.
8
The coronavirus outbreak could make it quicker and easier to trial drugs.冠状病毒的爆发可能会使药物试验更快、更容易。
Nature. 2020 Jun;582(7811):172. doi: 10.1038/d41586-020-01524-0.
9
Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases.优先审评券计划对罕见儿科疾病药物研发的影响。
Health Aff (Millwood). 2019 Feb;38(2):313-319. doi: 10.1377/hlthaff.2018.05330.
10
Uniting Discovery and Care: The Role of Pharmaceutical Companies in Research, Clinical Studies, and Patient Care.发现与关怀的融合：制药公司在研究、临床研究和患者护理中的作用。
J Invest Dermatol. 2020 Mar;140(3):527-530. doi: 10.1016/j.jid.2020.01.007. Epub 2020 Jan 20.

引用本文的文献

1
Requirements and special considerations for drug trials with children across six jurisdictions: 1. Clinical trial application review in the regulatory approval process.六个司法管辖区儿童药物试验的要求和特殊考虑因素：1. 监管审批过程中的临床试验申请审查。
Front Med (Lausanne). 2025 Apr 15;12:1542408. doi: 10.3389/fmed.2025.1542408. eCollection 2025.
2
The childhood cancer data initiative: enabling data sharing to drive research advances and transform pediatric cancer diagnosis and treatment.儿童癌症数据倡议：推动数据共享以促进研究进展并变革儿科癌症的诊断与治疗。
Curr Opin Pediatr. 2025 Feb 1;37(1):42-47. doi: 10.1097/MOP.0000000000001422. Epub 2024 Nov 27.
3
Paediatric strategy forum for medicinal product development of PI3-K, mTOR, AKT and GSK3β inhibitors in children and adolescents with cancer.
儿科药物研发策略论坛：针对癌症患儿和青少年的 PI3-K、mTOR、AKT 和 GSK3β 抑制剂
Eur J Cancer. 2024 Aug;207:114145. doi: 10.1016/j.ejca.2024.114145. Epub 2024 Jun 8.
4
Impact of ACCELERATE Paediatric Strategy Forums: a review of the value of multi-stakeholder meetings in oncology drug development.加速儿科战略论坛的影响：多利益相关者会议在肿瘤药物开发中的价值评估。
J Natl Cancer Inst. 2024 Feb 8;116(2):200-207. doi: 10.1093/jnci/djad239.
5
Paediatric Inflammatory Bowel Disease: A Multi-Stakeholder Perspective to Improve Development of Drugs for Children and Adolescents.儿科炎症性肠病：从多利益相关者角度出发，改善儿童和青少年用药研发。
J Crohns Colitis. 2023 Mar 18;17(2):249-258. doi: 10.1093/ecco-jcc/jjac135.
6
Immunotherapies for Pediatric Solid Tumors: A Targeted Update.儿童实体瘤的免疫治疗：靶向更新。
Paediatr Drugs. 2022 Jan;24(1):1-12. doi: 10.1007/s40272-021-00482-y. Epub 2021 Nov 25.
7
Intercontinental collaboration in clinical trials for children and adolescents with cancer-A systematic review by ACCELERATE.跨国合作在儿童和青少年癌症临床试验中的应用：一项由 ACCELERATE 进行的系统综述。
Cancer Med. 2021 Dec;10(23):8462-8474. doi: 10.1002/cam4.4356. Epub 2021 Oct 23.
8
Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans.发表的《儿科肿瘤学药物开发共同评论》：优化儿科开发计划全球监管协调的又一步。
Ther Innov Regul Sci. 2021 Nov;55(6):1109-1110. doi: 10.1007/s43441-021-00339-z. Epub 2021 Sep 8.
9
Navigating the Regulatory Landscape to Develop Pediatric Oncology Drugs: Expert Opinion Recommendations.儿科肿瘤药物研发的监管格局：专家意见建议
Paediatr Drugs. 2021 Jul;23(4):381-394. doi: 10.1007/s40272-021-00455-1. Epub 2021 Jun 26.
10
Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches.通过实用方法优化欧盟儿科医学发展
Clin Pharmacol Ther. 2021 Oct;110(4):871-879. doi: 10.1002/cpt.2152. Epub 2021 Feb 2.