Clinical trial considerations for pediatric cancer drug development
Author:
Affiliation:
1. Global Biostatistics, Amgen Inc, Thousand Oaks, CA, USA
2. Global Statistics and Data Sciences (GSDS), BeiGene USA, Fulton, MD, USA
3. Oncology Center of Excellence, Office of the Commissioner, U.S. FDA, Silver Spring, MD, USA
Funder
no funding
Publisher
Informa UK Limited
Subject
Pharmacology (medical),Pharmacology,Statistics and Probability
Link
https://www.tandfonline.com/doi/pdf/10.1080/10543406.2023.2172424
Reference98 articles.
1. Drug discovery in paediatric oncology: roadblocks to progress
2. A review of the experience with pediatric written requests issued for oncology drug products
3. Target and Agent Prioritization for the Children’s Oncology Group—National Cancer Institute Pediatric MATCH Trial
4. Master Protocols and Adaptive Trial Designs to Develop Tumor-Agnostic Drugs for Children
5. Navigating the Regulatory Landscape to Develop Pediatric Oncology Drugs: Expert Opinion Recommendations
Cited by 2 articles. 订阅此论文施引文献 订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献
1. Pediatric Cancer Drug Development: Leveraging Insights in Cancer Biology and the Evolving Regulatory Landscape to Address Challenges and Guide Further Progress;Cold Spring Harbor Perspectives in Medicine;2024-03-11
2. Pediatric needs should be considered early in the clinical development lifecycle;Journal of Biopharmaceutical Statistics;2023-08-08
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