Clausen Marc, Mighton Chloe, Kiflen Ruhi, Sebastian Agnes, Dai Wei Fang, Mercer Rebecca E, Beca Jaclyn M, Isaranuwatchai Wanrudee, Chan Kelvin K W, Bombard Yvonne
Li Ka Shing Knowledge Institute (Clausen, Mighton, Sebastian, Isaranuwatchai, Bombard), St. Michael's Hospital, Unity Health; Institute of Health Policy, Management and Evaluation (Mighton, Sebastian, Beca, Isaranuwatchai, Bombard), University of Toronto; Canadian Cancer Society (Kiflen); Cancer Care Ontario (Dai, Mercer, Beca, Chan), Ontario Health; Canadian Centre for Applied Research in Cancer Control (Dai, Mercer, Beca, Isaranuwatchai, Chan); Sunnybrook Health Sciences Centre (Chan), Toronto, Ont.
CMAJ Open. 2020 Nov 24;8(4):E772-E778. doi: 10.9778/cmajo.20200118. Print 2020 Oct-Dec.
Real-world evidence (RWE) can provide postmarket data to inform whether funded cancer drugs yield expected outcomes and value for money, but it is unclear how to incorporate RWE into Canadian cancer drug funding decisions. As part of the Canadian Real-World Evidence Value for Cancer Drugs (CanREValue) Collaboration, this study aimed to explore stakeholder perspectives on the current state of RWE in Canada to inform a Canadian framework for use of RWE in cancer drug funding decisions.
This was a qualitative descriptive study. Qualitative semistructured interviews were conducted from April to July 2018. Participants were Canadian and international stakeholders who had experience with RWE and drug funding decision-making. Thematic analysis was used to analyze data.
Thirty stakeholders participated in the study. Five themes were identified. Stakeholders indicated that RWE had value in cancer drug funding decisions. However, a cultural shift is needed to adopt RWE in decision-making. Further, the Canadian infrastructure for real-world data is currently inadequate for decision-making, and there is a need for committed investment in building capacity to collect and analyze RWE. Finally, there is a need for increased collaboration among key stakeholders.
The findings of this study suggest that if RWE is to be used in drug funding decisions, there is a need for a cultural shift, improved data infrastructure, committed investment in capacity building and increased stakeholder collaboration. Together with local stakeholder engagement, application of these findings may contribute to optimizing implementation of RWE.
真实世界证据（RWE）可以提供上市后数据，以了解获得资助的抗癌药物是否能产生预期结果和物有所值，但尚不清楚如何将RWE纳入加拿大抗癌药物资助决策中。作为加拿大抗癌药物真实世界证据价值（CanREValue）合作项目的一部分，本研究旨在探讨利益相关者对加拿大RWE现状的看法，以为加拿大在抗癌药物资助决策中使用RWE的框架提供参考。
这是一项定性描述性研究。2018年4月至7月进行了定性半结构化访谈。参与者是有RWE和药物资助决策经验的加拿大和国际利益相关者。采用主题分析法对数据进行分析。
30名利益相关者参与了该研究。确定了五个主题。利益相关者表示RWE在抗癌药物资助决策中有价值。然而，在决策中采用RWE需要文化转变。此外，加拿大的真实世界数据基础设施目前不足以支持决策，需要对收集和分析RWE的能力建设进行坚定投资。最后，关键利益相关者之间需要加强合作。
本研究结果表明，如果要在药物资助决策中使用RWE，就需要文化转变、改善数据基础设施、对能力建设进行坚定投资以及加强利益相关者合作。结合当地利益相关者的参与，应用这些研究结果可能有助于优化RWE的实施。
