ImportanceThe US leads the world in bringing new medical products to market, but the ability to generate evidence to inform clinical practice in postmarket settings needs improvement. Although a diverse group of stakeholders is working to improve postmarket evidence generation, the role of private payers has been underappreciated.ObservationsPayers are crucial allies in improving evidence generation because better data would better inform coverage decisions, their policies and practices influence the conduct of care and research, and their claims data are a source of real-world evidence used in medical product evaluation. In addition, payers have a stake in improving evidence generation because the kinds of evidence needed to inform health care and coverage decisions are often not available when a product enters the market and may not be generated without their involvement. Here, we describe several key steps payers could take to improve evidence generation, including participating in efforts to reduce administrative and financial barriers to the conduct of clinical trials, directly incentivizing evidence generation on high-priority questions by funding potential cost-saving trials, increasing engagement with the medical products industry on evidentiary needs for coverage decisions, and improving usability of claims data by reducing data lags and routinely recording unique device identifiers. Broad payer engagement with US Food and Drug Administration recommendations regarding evidence generation will ensure that the opportunities to participate in clinical research are extended to all communities and that evidence needed to inform care is generated in trials and surveillance systems that reflect the clinical reality across the US.Conclusions and RelevanceIncreasing payer involvement in evidence generation can benefit all participants in the medical innovation ecosystem. The importance of payers in these efforts will continue to grow in response to imperatives to increase integration of care and research, engage a diverse set of communities in clinical research, and move toward alternative payment models.

中文翻译：

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为什么证据生成对付款人很重要以及他们如何提供帮助


重要性美国在将新医疗产品推向市场方面处于世界领先地位，但为上市后临床实践提供证据的能力需要改进。尽管不同的利益相关者群体正在努力改善上市后证据的生成，但私人付款人的作用一直被低估。观察付款人是改善证据生成的重要盟友，因为更好的数据可以更好地为承保决策提供信息，他们的政策和实践会影响护理和治疗的行为。研究及其索赔数据是医疗产品评估中使用的真实世界证据的来源。此外，付款人在改善证据生成方面也有利害关系，因为当产品进入市场时，为医疗保健和承保决策提供信息所需的各种证据通常无法获得，并且如果没有他们的参与，也可能无法生成这些证据。在这里，我们描述了付款人可以采取的改善证据生成的几个关键步骤，包括参与减少进行临床试验的行政和财务障碍的努力，通过资助潜在的节省成本的试验直接激励高优先级问题的证据生成，增加与医疗产品行业就承保决策的证据需求进行互动，并通过减少数据滞后和定期记录唯一设备标识符来提高索赔数据的可用性。付款人广泛参与美国食品和药物管理局关于证据生成的建议，将确保参与临床研究的机会扩展到所有社区，并在反映美国临床现实的试验和监测系统中生成指导护理所需的证据。结论和相关性增加付款人参与证据生成可以使医疗创新生态系统中的所有参与者受益。付款人在这些努力中的重要性将继续增长，以响应加强护理和研究一体化、让不同社区参与临床研究以及转向替代支付模式的迫切需要。