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监管与创新重点是否满足公共卫生需求?

Are Regulation and Innovation Priorities Serving Public Health Needs?

作者信息

Milne Christopher-Paul, Kaitin Kenneth I

机构信息

Tufts Center for the Study of Drug Development, Tufts University, Boston, MA, United States.

出版信息

Front Pharmacol. 2019 Mar 8;10:144. doi: 10.3389/fphar.2019.00144. eCollection 2019.

DOI:10.3389/fphar.2019.00144
PMID:30906258
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6419525/
Abstract

A host of challenges confront healthcare authorities worldwide. Topping the list is the demand for innovative new medicines to treat a range of both infectious and non-communicable diseases, while containing spiraling healthcare costs. The challenge is particularly great in therapeutic areas where, despite significant medical need and economic impact, the technical challenges and commercial risk of development serve as disincentives to drug sponsors. These areas include cardiovascular diseases as well as diseases and disorders of the central nervous system. Currently, the development and approval of new active substances, with its disproportionate focus on oncology, is not in alignment with healthcare needs in most geographic regions. In this article, we discuss the origins of this misalignment and suggest various approaches to address healthcare needs going forward.

摘要

全球医疗保健当局面临着诸多挑战。首要挑战是需要创新型新药来治疗一系列传染病和非传染病,同时控制不断攀升的医疗成本。在一些治疗领域,这一挑战尤为严峻,尽管存在重大医疗需求和经济影响,但开发的技术挑战和商业风险阻碍了制药商的积极性。这些领域包括心血管疾病以及中枢神经系统疾病和障碍。目前,新活性物质的开发和审批过度集中于肿瘤学,与大多数地理区域的医疗需求不一致。在本文中,我们将探讨这种不一致的根源,并提出应对未来医疗需求的各种方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa41/6419525/b82ca574b7c0/fphar-10-00144-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa41/6419525/5f13c0f97a84/fphar-10-00144-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa41/6419525/b82ca574b7c0/fphar-10-00144-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa41/6419525/5f13c0f97a84/fphar-10-00144-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa41/6419525/b82ca574b7c0/fphar-10-00144-g0002.jpg

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Prospects for rapid advances in the development of new medicines for special medical needs.特殊医疗需求新药研发的快速进展前景。
Clin Pharmacol Ther. 2014 Jan;95(1):98-109. doi: 10.1038/clpt.2013.155. Epub 2013 Aug 5.
Social Pharmacology as an Underappreciated Field in Medical Education: A Single Medical School's Experience.
社会药理学作为医学教育中一个未得到充分重视的领域:一所医学院校的经验
Front Pharmacol. 2021 Aug 16;12:714707. doi: 10.3389/fphar.2021.714707. eCollection 2021.