Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia.
Centre for Big Data Research in Health, Faculty of Medicine, UNSW Sydney, NSW 2052, Australia.
Int J Popul Data Sci. 2022 Jun 13;6(3):1726. doi: 10.23889/ijpds.v6i1.1726. eCollection 2021.
Regulators and payers play a pivotal role in facilitating timely and affordable access to safe and efficacious medicines. They use evidence generated from randomised clinical trials (RCTs) to support decisions to register and subsidise medicines. However, at the time of registration and subsidy approval, regulators and payers face uncertainty about how RCT outcomes will translate to real-world clinical practice. In response to this situation, medicines policy agencies worldwide have endorsed the use of real-world data (RWD) to derive novel insights on the use and outcomes of prescribed medicines. Recent reforms around data availability and use in Australia are creating unparalleled data access and opportunities for Australian researchers to undertake large-scale research to generate evidence on the safety and effectiveness of medicines in the real world. Highlighting the critical importance of research in this area, Quality Use of Medicines and Medicine Safety was announced as Australia's 10th National Health Priority in 2019. The National Health and Medical Research Council, Medicines Intelligence Centre of Research Excellence (MI-CRE) has been formed to take advantage of the renewed focus on quality use of medicines and the changing data landscape in Australia. It will generate timely research supporting the evidentiary needs of Australian medicines regulators and payers by accelerating the development and translation of real-world evidence on medicines use and outcomes. MI-CRE is developing a coordinated approach to identify, triage and respond to priority questions where there are significant uncertainties about medicines use, (cost)-effectiveness, and/or safety and creating a data ecosystem that will streamline access to Australian data to enable researchers to generate robust evidence in a timely manner. This paper outlines how MI-CRE will partner with policy makers, clinicians, and consumer advocates to leverage real-world data to co-create real-world evidence, to improve quality use of medicines and reduce medicine-related harm.
监管机构和支付方在促进安全有效的药物的及时和可负担获取方面发挥着关键作用。他们利用来自随机临床试验（RCT）的证据来支持药品注册和补贴的决策。然而，在注册和补贴批准时，监管机构和支付方对于 RCT 结果如何转化为实际临床实践存在不确定性。为了应对这种情况，全球药品政策机构已经认可使用真实世界数据（RWD）来深入了解规定药物的使用和结果。澳大利亚最近在数据可用性和使用方面的改革为澳大利亚研究人员创造了无与伦比的数据访问和机会，使他们能够进行大规模研究，以生成有关药物在真实世界中安全性和有效性的证据。2019 年，澳大利亚将“合理用药与药物安全”列为第 10 个国家卫生重点，强调了该领域研究的至关重要性。国家卫生和医学研究理事会成立了药品情报中心卓越研究（MI-CRE），以利用对合理用药的重新关注和澳大利亚数据环境的变化。它将通过加速开发和转化有关药物使用和结果的真实世界证据，为澳大利亚药品监管机构和支付方提供及时的研究支持，以满足他们的证据需求。MI-CRE 正在制定一种协调的方法，以确定、筛选和应对有关药物使用、（成本）效益和/或安全性的重大不确定性的优先问题，并创建一个数据生态系统，以简化对澳大利亚数据的访问，使研究人员能够及时生成可靠的证据。本文概述了 MI-CRE 将如何与政策制定者、临床医生和消费者权益倡导者合作，利用真实世界数据共同创建真实世界证据，以改善合理用药并减少药物相关伤害。
