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Herding in the drug development pipeline.药物研发流程中的集中趋势。
Nat Rev Drug Discov. 2023 Aug;22(8):617-618. doi: 10.1038/d41573-023-00063-3.
3
Organizing precision medicine: A case study of Memorial Sloan Kettering Cancer Center's engagement in/with genomics.组织精准医学:以纪念斯隆凯特琳癌症中心参与/从事基因组学为例。
Soc Sci Med. 2023 May;324:115789. doi: 10.1016/j.socscimed.2023.115789. Epub 2023 Feb 18.
4
Delivering precision oncology to patients with cancer.为癌症患者提供精准肿瘤学治疗。
Nat Med. 2022 Apr;28(4):658-665. doi: 10.1038/s41591-022-01717-2. Epub 2022 Apr 19.
5
Accelerated approvals under the microscope.显微镜下的加速批准
Nat Rev Drug Discov. 2021 Jun;20(6):409-411. doi: 10.1038/d41573-021-00089-5.
6
Actionable data for precision oncology: Framing trustworthy evidence for exploratory research and clinical diagnostics.精准肿瘤学的可操作数据:为探索性研究和临床诊断构建可信证据。
Soc Sci Med. 2021 Mar;272:113760. doi: 10.1016/j.socscimed.2021.113760. Epub 2021 Feb 11.
7
Review of precision cancer medicine: Evolution of the treatment paradigm.精准肿瘤医学述评:治疗范式的演变。
Cancer Treat Rev. 2020 Jun;86:102019. doi: 10.1016/j.ctrv.2020.102019. Epub 2020 Mar 31.
8
FDA Approval and Regulation of Pharmaceuticals, 1983-2018.FDA 对药品的批准与监管,1983-2018 年。
JAMA. 2020 Jan 14;323(2):164-176. doi: 10.1001/jama.2019.20288.
9
Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols.系统评价篮子试验、伞式试验和平台试验:主方案的全景分析。
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10
Genomic expertise in action: molecular tumour boards and decision-making in precision oncology.基因组学专业知识的应用:分子肿瘤委员会与精准肿瘤学决策
Sociol Health Illn. 2019 Nov;41(8):1568-1584. doi: 10.1111/1467-9566.12970. Epub 2019 Jun 13.

决策即发现:在领先的精准肿瘤学服务中审查临床研究。

Decision-making as discovery: Vetting clinical research in a leading precision oncology service.

机构信息

Department of Social Studies of Medicine, McGill University, Montreal, Quebec, Canada.

Early Drug Development Service and Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York City, New York, USA.

出版信息

Sociol Health Illn. 2024 Mar;46(3):495-513. doi: 10.1111/1467-9566.13719. Epub 2023 Oct 5.

DOI:10.1111/1467-9566.13719
PMID:37796533
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11878200/
Abstract

Based on fieldwork carried out at the Early Drug Development Service of a world-leading cancer institution, our study sheds lights on decision-making processes at the stage where decisions are made about which clinical trial to pursue and thus which experimental drugs will feed the growing pipeline of molecularly guided therapies and therapeutic strategies available to treating physicians. The paper shows how such collective decision-making practices by a translational research unit employ formal tools and ad hoc valuation strategies that interweave technical-scientific matters of concern with patient-oriented clinical ones, as part of the institutional assetization of biomedical knowledge production. In the process, decision-making practices in part define the conditions of possibility for the provision of care in what is increasingly becoming a 'clinic of variants.' They do so by reconfiguring on an evolving basis the socio-material ecosystem through which precision oncology is enacted as a rapidly evolving assemblage of patients, physicians, research and support staff, protocols, molecular markers, drugs and administrative components.

摘要

基于在一家世界领先癌症机构的早期药物开发服务部门进行的实地调查,我们的研究揭示了在决定选择哪种临床试验以及哪些实验性药物将为不断增长的分子指导治疗和治疗策略管道提供支持的阶段的决策过程。本文展示了这种由转化研究单位进行的集体决策实践如何采用正式工具和特定的评估策略,将与患者相关的临床问题与关注的技术科学问题交织在一起,作为生物医学知识生产的机构资产化的一部分。在这个过程中,决策实践部分定义了在日益成为“变异诊所”的环境中提供护理的可能性条件。它们通过在不断发展的基础上重新配置通过精密肿瘤学作为一个快速发展的患者、医生、研究和支持人员、方案、分子标记物、药物和行政组成部分的不断发展的组合来实现这一点。