改善數據驅動醫學：加拿大RWE（真實世界證據）的現狀（2020年）

RWE（真實世界證據）是一種重要的分析工具，可加強臨床試驗中隨機試驗的證據，但其質量和可靠性也很差。因此，它被用作加強各種決策（醫療技術評估（HTA），包括基於條件的合同）的方法，而不是啟動後的有效性分析。加拿大開始在藥品和醫療設備的認證過程中使用RWE。

本報告分析了加拿大RWE（真實世界證據）戰略的發展狀況，概述了RWE，其他地區（美國/歐洲）的實施狀況，加拿大政府的戰略指南以及癌症治療。我們將收集和提供信息，例如醫學的實際發展狀況，未來的機遇和挑戰。

執行摘要

概述

• 加拿大政府RWE戰略：背景
  • 定義
    • 主要用法示例
    • 主要用戶
    • 主要問題
  • 美國的背景情況
  • 歐洲隨行隨行
  • 加拿大政府RWE策略/活動
    • RWE在藥品監管決策中
    • RWE在醫療器械法規決策中

對技術買家的建議

• 當前的RWE：案例研究
  • CanREValue（加拿大癌症藥物的RWE）
    • 以患者為中心的研究策略：加拿大數據平台
  • 主要結論

參考

• 相關研究
• 摘要

This IDC Perspective outlines the current status of Canada's national strategy to optimize the use of real-world evidence based on real-world data for drugs and medical devices and places it within the international context, focusing on parallel activities in the United States and the EU. Real-world evidence derived from RWD presents a significant opportunity to enhance the evidence generated from randomized controlled trials. However, RWE continues to be viewed by most stakeholders as lower quality and less reliable than randomized controlled trials, which continue to be viewed as generating superior evidence. As a result, there are higher comfort levels for using RWE in relation to economic decision making such as HTA recommendations and conditional outcomes-based contracting than for using RWE as evidence of post-market effectiveness.Processes to create a national framework for use of RWE are still at an early stage. Although Canada has separate framework development processes for pharmaceutical drugs and medical devices, it appears to have similar goals and outlines, although slightly different participant structures."The market would welcome a national framework that provides clear guidance on consistent processes, timing, and methods for use of RWE in health sector regulatory decisions," says Mark Schrutt, IDC Canada's strategic advisor, Innovation and Public Sector Research.

Executive Snapshot

Situation Overview

• Context of Canada's National Real-World Evidence Strategy
  • Definitions
    • Key Use Cases
    • Key Users
    • Key Challenges
  • American Context
  • European RWD
  • Canadian National RWE Strategy Initiative
    • RWE in Drug Regulatory Decisions
    • RWE in Medical Device Regulatory Decisions

Advice for the Technology Buyer

• Real-World Evidence in Action: Case Study
  • Canadian Real-World Evidence for Value in Cancer (CanREValue)
    • The Strategy for Patient-Oriented Research: Canadian Data Platform
  • Key Takeaways

Learn More

• Related Research
• Synopsis