Patients, as direct experiencers of illness, subjects of clinical trials, and participants in medical practices, have the most immediate and clear understanding of their disease experiences and health needs. Consequently, drug regulatory agencies in many countries have successively proposed the "patient-centered" concept, hoping to increase the pathways for patients to actively participate in medical decision-making, drug development, and clinical trials through patient experience, feelings, and needs, and other patient experience data. This article systematically reviews the evolution of patient experience data, organizes its definitions, scope, sources, and collection methods, analyzes the application value and key links of patient experience data, and provides references for further research. The study found that although patient experience data can be widely used in the development of clinical outcome assessment tools, drug development, regulatory decision-making, and the improvement of clinical trial design, there is still a lack of standardized collection processes, standardized identification and screening technologies, and correct application of methodological guidance. Based on this, future efforts require researchers, patient groups, and government agencies, and other stakeholders to work together to improve and promote the collection, identification, screening, and application of patient experience data.

患者作为疾病亲身经历者、临床试验受试者和医疗实践参与者，对疾病的体验及需求最为直接与明确。多国药品监管机构相继提出"以患者为中心"的理念，希望通过患者体验、感受和需求等患者体验数据，增加患者主动参与医疗决策、药物研发和临床试验的途径。本文通过系统梳理患者体验数据的演进历程，整理其定义、范围、来源和收集方法，剖析患者体验数据的应用价值及关键环节，为进一步研究提供参考。研究发现，尽管患者体验数据可广泛用于临床结局评估工具研制、药物研发和监管决策、完善临床试验设计等多个领域，但当前仍缺乏标准化的收集流程、规范化的识别和筛选技术及正确应用的方法学指导等。基于此，未来需要研究人员、患者群体和卫生行政部门等多方利益相关者通力合作，共同完善和推动患者体验数据的收集、识别、筛选和应用。