Hampson Grace, Towse Adrian, Dreitlein William B, Henshall Chris, Pearson Steven D
Office of Health Economics, Southside, London, SW1E 6QT, UK.
Institute for Clinical & Economic Review, Boston, MA, 02109, USA.
J Comp Eff Res. 2018 Dec;7(12):1133-1143. doi: 10.2217/cer-2018-0066. Epub 2018 Nov 9.
To explore current uses of real-world evidence (RWE) in the US healthcare system, summarize key concerns and highlight various opportunities that could be realized through best use of RWE. Materials & methods: Information was gathered via a literature review and interviews to generate a background paper for the 2017 Institute for Clinical and Economic Review Policy Summit meeting.
RWE is currently being utilized in drug development decisions, regulatory approval decisions, post-approval monitoring, payer coverage decisions (initial decisions and reassessments) and for outcomes-based contracting. Solutions to key challenges and opportunities for future development are presented.
Exciting opportunities for the use of RWE exist, yet important reservations remain. Solutions are within reach if effective partnerships between stakeholders can be nurtured.
探讨真实世界证据（RWE）在美国医疗保健系统中的当前用途，总结关键问题，并强调通过最佳利用RWE可实现的各种机遇。材料与方法：通过文献综述和访谈收集信息，以生成2017年临床与经济审查政策峰会会议的背景文件。
RWE目前正用于药物研发决策、监管审批决策、批准后监测、支付方覆盖决策（初始决策和重新评估）以及基于结果的合同。提出了关键挑战的解决方案和未来发展机遇。
使用RWE存在令人兴奋的机遇，但也存在重要的保留意见。如果能培育利益相关者之间的有效合作关系，解决方案是可以实现的。
