he costs of cancer drugs are rising rapidly. 1,2 Although some new drugs provide substantial therapeutic improvements, others confer only marginal survival benefits or improve only quality of life. Assessment of the overall costs and benefits of cancer drugs is essential for resource allocation. Drug funding decision-makers typically rely on data from clinical trials to supply clinical and economic evidence. 3,4 However, randomized controlled trials (RCTs) have highly selected populations, limiting their real-world generalizability. 5-9 Funding decisions are not revisited, and cost-effectiveness and clinical effectiveness are not reassessed , after a drug enters the Canadian market. 10 Decision-makers have little information on whether drug investments yield expected outcomes. 10 Real-world evidence (RWE)-evidence from postmarket evaluations not derived from traditional RCTs 11-could fill these gaps with information on clinical effectiveness, safety, costeffectiveness and budget impact outside of the highly controlled trial environment. 3,5,6,12 The Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration, consisting of stakeholders in cancer control across and outside Canada (e.g., researchers, government ministries, decision-makers, payers, patients and caregivers), 10 was formed to create an RWE framework to apply to cancer drug funding in Canada. The aim of this study was to inform CanREValue's framework development through an exploration of Canadian and international stakeholders' views and experiences with RWE, such that the framework would address end users' needs and facilitate the uptake of RWE into cancer drug funding decision-making.
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