Department of Oncology, McMaster University, Hamilton, ON L8S 4L8, Canada.
Ontario Health (CCO), Toronto, ON M5G 2L3, Canada.
Curr Oncol. 2022 Aug 7;29(8):5616-5626. doi: 10.3390/curroncol29080443.
The Canadian Real-world Evidence for Value in Cancer Drugs (CanREValue) Collaboration established the Engagement Working Group (WG) to ensure that all key stakeholders had an opportunity to provide input into the development and implementation of the CanREValue Real-World Evidence (RWE) Framework. Two consultations were held in 2021 to solicit patient perspectives on key policy and data access issues identified in the interim policy and data WG reports. Over 30 individuals, representing patients, caregivers, advocacy leaders, and individuals engaged in patient research were invited to participate. The consultations provided important feedback and valuable lessons in patient engagement. Patient leaders actively shaped the process and content of the consultation. Breakout groups facilitated by patient advocacy leaders gave the opportunity for open and thoughtful contributions from all participants. Important recommendations were made: the RWE framework should not impede access to new drugs; it should be used to support conditional approvals; patient relevant endpoints should be captured in provincial datasets; access to data to conduct RWE should be improved; and privacy issues must be considered. The manuscript documents the CanREValue experience of engaging patients in a consultative process and the useful contributions that can be achieved when the processes to engage are guided by patients themselves.
加拿大癌症药物价值真实世界证据（CanREValue）合作组织成立了参与工作组（WG），以确保所有主要利益相关者都有机会就 CanREValue 真实世界证据（RWE）框架的制定和实施提供意见。2021 年举行了两次磋商，征求患者对临时政策和数据工作组报告中确定的关键政策和数据获取问题的看法。邀请了 30 多名代表患者、护理人员、倡导领袖以及参与患者研究的个人的人员参加磋商。磋商提供了重要的反馈和患者参与方面的宝贵经验。患者领袖积极塑造了磋商的过程和内容。由患者倡导领袖主持的分组讨论为所有参与者提供了开放和深思熟虑的贡献机会。提出了一些重要建议：RWE 框架不应阻碍新药的获取；应将其用于支持有条件批准；应在省级数据集中捕获与患者相关的终点；应改善进行 RWE 的数据获取；必须考虑隐私问题。本文档记录了 CanREValue 在协商过程中让患者参与的经验，以及当参与过程由患者自己指导时可以取得的有用贡献。
