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数据共享对推进药物研发的价值:监管视角。

Value of Data Sharing to Advance Drug Development: A Regulatory Perspective.

机构信息

Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, MD, USA.

出版信息

Ther Innov Regul Sci. 2021 Jul;55(4):850-852. doi: 10.1007/s43441-021-00275-y. Epub 2021 Apr 19.

Abstract

New tools are needed to evaluate and predict the efficacy and safety of medical products. However, the development of such tools requires collaboration and effective data sharing. In this issue of Therapeutic Innovation & Regulatory Science, scientists from the Critical Path Institute (C-Path) discuss their experiences using patient-level data to facilitate innovation in drug development. We share our perspective on the issues discussed in the C-Path paper and offer suggestions on future efforts.

摘要

需要新的工具来评估和预测医疗产品的疗效和安全性。然而,此类工具的开发需要协作和有效的数据共享。在本期《治疗创新与监管科学》中,来自关键路径研究所(C-Path)的科学家讨论了他们使用患者水平数据促进药物开发创新的经验。我们分享了对 C-Path 论文中讨论问题的看法,并就未来的努力提出了建议。

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