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药物适应患者的途径：为什么、何时以及如何参与？

Medicines Adaptive Pathways to Patients: Why, When, and How to Engage?

机构信息

European Medines Agency (EMA), London, UK.

European Patients Forum, Brussels, Belgium.

出版信息

Clin Pharmacol Ther. 2019 May;105(5):1148-1155. doi: 10.1002/cpt.1121. Epub 2018 Sep 11.

DOI:10.1002/cpt.1121
PMID:29901216
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6585618/
Abstract

Medicines Adaptive Pathways to Patients (MAPPs) seeks to foster access to novel beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span, in a sustainable fashion. We summarize the MAPPs engagement process and critical questions to be asked at each milestone of the product life-span. These considerations are of relevance for regulatory and access pathways that strive to address the "evidence vs. access" conundrum.

摘要

药品适应性途径至患者（MAPPs）旨在促进在产品生命周期内尽早为合适的患者群体以可持续的方式获得新颖的有益治疗。我们总结了 MAPPs 参与过程以及在产品生命周期的每个里程碑需要提出的关键问题。这些考虑因素与监管和准入途径相关，旨在解决“证据与准入”难题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/772b/6585618/597b88aec7f0/CPT-105-1148-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/772b/6585618/65b4418a9d13/CPT-105-1148-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/772b/6585618/597b88aec7f0/CPT-105-1148-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/772b/6585618/65b4418a9d13/CPT-105-1148-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/772b/6585618/597b88aec7f0/CPT-105-1148-g002.jpg

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本文引用的文献

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Ther Innov Regul Sci. 2016 May;50(3):347-354. doi: 10.1177/2168479015618697.
2
Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe.欧洲适应性途径背景下的药品管理进入协议
Front Pharmacol. 2018 Mar 27;9:280. doi: 10.3389/fphar.2018.00280. eCollection 2018.
3
Payers' Views of the Changes Arising through the Possible Adoption of Adaptive Pathways.
利用患者视角为更好的临床试验设计和实施提供信息：当前趋势和未来方向。
Pharmaceut Med. 2023 Mar;37(2):129-138. doi: 10.1007/s40290-022-00458-4. Epub 2023 Jan 18.
4
Understanding multi-stakeholder needs, preferences and expectations to define effective practices and processes of patient engagement in medicine development: A mixed-methods study.了解多方利益相关者的需求、偏好和期望，以定义药物研发中患者参与的有效实践和流程：一项混合方法研究。
Health Expect. 2021 Apr;24(2):601-616. doi: 10.1111/hex.13207. Epub 2021 Feb 17.
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Current challenges for assessing the long-term clinical benefit of cancer immunotherapy: a multi-stakeholder perspective.评估癌症免疫疗法长期临床获益的当前挑战：多利益相关者视角。
J Immunother Cancer. 2020 Jul;8(2). doi: 10.1136/jitc-2020-000648.
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Innovation in Regulatory Science Is Meeting Evolution of Clinical Evidence Generation.监管科学的创新正在适应临床证据生成的演变。
Clin Pharmacol Ther. 2019 Apr;105(4):886-898. doi: 10.1002/cpt.1354.
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Front Pharmacol. 2016 Sep 28;7:305. doi: 10.3389/fphar.2016.00305. eCollection 2016.
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