NICHD HUMAN BIOSPECIMEN REPOSITORY- REPOSITORY SERVICES FOR THE BEST PHARMACEUTICALS FOR CHILDREN ACT (BPCA) AND PEDIATRIC TRIALS NETWORK (PTN)

NICHD 人类生物样本存储库 - 最佳儿童药物存储服务法案 (BPCA) 和儿科试验网络 (PTN)

• 批准号: 10927712
• 负责人: BRITTANY MARTIN
• 金额: $ 4.56万
• 依托单位: FISHER BIOSERVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-19 至 2024-09-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10927712
• 关键词: Address; Age; Bar Codes; Best Pharmaceuticals for Children Act; Biological Specimen Banks; Blood; Cells; Child; Childhood; Conduct Clinical Trials; Congresses; Contracts; Data; Drug Prescriptions; Dryness; Ensure; Equipment and supply inventories; Erythrocytes; Formulation; Funding; Goals; Human; Human Milk; Knowledge; Label; Modification; Monitor; National Institute of Child Health and Human Development; Online Systems; Orphan; Pharmaceutical Preparations; Pharmacologic Substance; Plasma; Research; Safety; Sampling; Serum; Services; Specimen; Spottings; System; Testing; Therapeutic; Tube; dose information; improved; repository

Children have been termed therapeutic orphans due to the lack of adequate dosing information, age appropriate formulations, and efficacy and safety information regarding prescribed drugs. The majority of drugs are still used in children off label. To improve knowledge in this field, Congress enacted The Best Pharmaceuticals for Children Act (BPCA) in 2002, BPCA was reauthorized in 2007 and 2012. The NICHD has the primary responsibility to administer, contract, and monitor studies that develop data for potential modification to will benefit children. Through these studies, a large number of biospecimens are generated. It is anticipated that samples in long term storage will be shared for secondary research. The Pediatric Trials Network is an NICHD-funded Network that conducts clinical trials aimed at addressing goals of the BPCA. This network generates are biospecimens from children that are invaluable for advancing understanding of the effect of pharmaceuticals in children.

由于缺乏足够的剂量信息、适合年龄的配方以及处方药的功效和安全性信息，儿童被称为治疗孤儿。大多数药物仍在标签外用于儿童。为了提高这一领域的知识，国会于 2002 年颁布了《儿童最佳药品法案》(BPCA)，并于 2007 年和 2012 年重新获得授权。 NICHD 的主要责任是管理、签约和监督研究，这些研究开发数据以进行潜在的修改以使儿童受益。通过这些研究，产生了大量的生物样本。预计长期储存的样本将被共享用于二次研究。儿科试验网络是一个由 NICHD 资助的网络，旨在开展旨在实现 BPCA 目标的临床试验。该网络生成的儿童生物样本对于增进了解药物对儿童的影响非常宝贵。