The 21st Century Cures Act encourages the Food and Drug Administration to consider “real-world evidence” in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority of patients in fact receive care in the fragmented U.S. healthcare system. This move is especially important if innovations are to reach, and be validated in, more diverse populations. A solution can be found in the 183 Practiced-Based Research Networks (“PBRN”), i.e., groups of primary care clinicians and practices in all 50 states working to improve clinical care and translate research findings into practice. This symposium contribution seeks to (1) describe some of the common shortcomings of clinical trials, (2) explore the opportunities and challenges posed by use of real-world evidence as a basis for drug and device regulation, (3) briefly describe the history and evolution of PBRNs, and (4) articulate the challenges and opportunities for using PBRNs to fulfill the 21st Century Cures Act mandate for real-world evidence.

中文翻译：

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基于实践的研究网络和对真实世界证据的要求

21英石世纪治愈法案鼓励食品和药物管理局在其对药物和设备的安全性和有效性的监管中考虑“真实世界的证据”。许多人将这一任务解释为专注于非随机观察研究。然而，我们建议监管科学也必须从稀有的学术医院转移到以社区为基础的环境中，事实上，绝大多数患者在分散的美国医疗保健系统中接受护理。如果创新要触及更多样化的人群并在更多样化的人群中得到验证，这一举措尤其重要。可以在 183 个基于实践的研究网络 (“PBRN”) 中找到解决方案，即所有 50 个州的初级保健临床医生和实践小组致力于改善临床护理并将研究成果转化为实践。英石Century Cures Act 对真实世界证据的授权。