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物的疗效和安全性信息，儿童被称为治疗孤儿。大多数药物仍然用于儿童标签外。为了提高这一领域的知识，美国国会于2002年颁布了《儿童最佳药物法》（BPCA），BPCA在2007年和2012年重新获得授权。 NICHD的主要责任是管理、签订合同和监测研究，这些研究开发了可能修改的数据，以使儿童受益。通过这些研究，产生了大量的生物标本。预计长期储存的样本将用于二次研究。儿科试验网络是NICHD资助的网络，旨在实现BPCA的目标进行临床试验。这个网络产生的是来自儿童的生物标本，对于促进对儿童药物影响的理解是非常宝贵的。