Bhatt Arun
Consultant - Clinical Research and Development, Mumbai, Maharashtra, India.
Perspect Clin Res. 2019 Apr-Jun;10(2):51-56. doi: 10.4103/picr.PICR_8_19.
Real-world data (RWD) are data relating to patients' health status and/or the delivery of health care routinely collected from a variety of sources. Real-world evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can provide information on diverse areas, for example, natural history and course of disease, effectiveness studies, outcome research, and safety surveillance. India has unique opportunity of conducting RWE studies in several interesting areas, for example, natural history of communicable and noncommunicable diseases and rare disease and Health Economics and Outcomes Research in public versus private hospitals. However, utility of RWE is challenged by diversity of information, large data sets of uncertain quality, and methodological rigor. For India, there are additional challenges in conducting RWE studies - Indian clinical practice pattern and physicians' interest in RWE studies. It is recommended that RWE studies in India should focus on health management issues of relevance to the country India and should be well planned to generate high-quality data.
真实世界数据（RWD）是指从各种来源常规收集的与患者健康状况和/或医疗保健提供相关的数据。真实世界证据（RWE）是指通过对真实世界数据的分析得出的关于医疗产品使用情况以及潜在益处或风险的临床证据。真实世界证据可以在多个不同领域提供信息，例如疾病的自然史和病程、有效性研究、结局研究以及安全性监测。印度在几个有趣的领域开展真实世界证据研究拥有独特的机会，例如传染病和非传染病以及罕见病的自然史，以及公立和私立医院的卫生经济学与结局研究。然而，真实世界证据的效用受到信息多样性、质量不确定的大数据集以及方法严谨性的挑战。对于印度而言，开展真实世界证据研究还存在其他挑战——印度的临床实践模式以及医生对真实世界证据研究的兴趣。建议印度的真实世界证据研究应聚焦于与印度相关的健康管理问题，并且应精心规划以生成高质量数据。
