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真实世界数据对生物制药演进所面临挑战的积极影响。

The positive impacts of Real-World Data on the challenges facing the evolution of biopharma.

机构信息

Pistoia Alliance, Wakefield, MA, USA.

Bayer, Berlin, Germany.

出版信息

Drug Discov Today. 2018 Apr;23(4):788-801. doi: 10.1016/j.drudis.2018.01.034. Epub 2018 Jan 11.

DOI:10.1016/j.drudis.2018.01.034
PMID:29337204
Abstract

Demand for healthcare services is unprecedented. Society is struggling to afford the cost. Pricing of biopharmaceutical products is under scrutiny, especially by payers and Health Technology Assessment agencies. As we discuss here, rapidly advancing technologies, such as Real-World Data (RWD), are being utilized to increase understanding of disease. RWD, when captured and analyzed, produces the Real-World Evidence (RWE) that underpins the economic case for innovative medicines. Furthermore, RWD can inform the understanding of disease, help identify new therapeutic intervention points, and improve the efficiency of research and development (R&D), especially clinical trials. Pursuing precompetitive collaborations to define shared requirements for the use of RWD would equip service-providers with the specifications needed to implement cloud-based solutions for RWD acquisition, management and analysis. Only this approach would deliver cost-effective solutions to an industry-wide problem.

摘要

医疗保健服务的需求前所未有。社会正在努力承担成本。生物制药产品的定价受到审查,尤其是支付者和医疗技术评估机构。正如我们在这里讨论的那样,快速发展的技术,如真实世界数据(RWD),正在被用于提高对疾病的理解。RWD 在被捕获和分析时,会产生 Real-World Evidence(RWE),为创新药物的经济案例提供依据。此外,RWD 可以帮助了解疾病,帮助发现新的治疗干预点,并提高研究和开发(R&D)的效率,特别是临床试验。开展竞争前合作,定义 RWD 使用的共享要求,将使服务提供商具备实施基于云的 RWD 采集、管理和分析解决方案所需的规范。只有这种方法才能为整个行业的问题提供具有成本效益的解决方案。

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