药物警戒
生物制药
大数据
疾病
药物开发
数据科学
药物发现
精密医学
比例(比率)
公共卫生
生物标志物发现
医学
业务
计算机科学
药品
生物信息学
生物技术
药理学
数据挖掘
地理
病理
生物
基因
地图学
生物化学
蛋白质组学
作者
Gurinder Singh,Duane Schulthess,Nigel Hughes,Bart Vannieuwenhuyse,Dipak Kalra
标识
DOI:10.1016/j.drudis.2017.12.002
摘要
The objective of this paper is to identify the extent to which real world data (RWD) is being utilized, or could be utilized, at scale in drug development. Through screening peer-reviewed literature, we have cited specific examples where RWD can be used for biomarker discovery or validation, gaining a new understanding of a disease or disease associations, discovering new markers for patient stratification and targeted therapies, new markers for identifying persons with a disease, and pharmacovigilance. None of the papers meeting our criteria was specifically geared toward novel targets or indications in the biopharmaceutical sector; the majority were focused on the area of public health, often sponsored by universities, insurance providers or in combination with public health bodies such as national insurers. The field is still in an early phase of practical application, and is being harnessed broadly where it serves the most direct need in public health applications in early, rare and novel disease incidents. However, these exemplars provide a valuable contribution to insights on the use of RWD to create novel, faster and less invasive approaches to advance disease understanding and biomarker discovery. We believe that pharma needs to invest in making better use of Electronic Health Records and the need for more precompetitive collaboration to grow the scale of this ‘big denominator’ capability, especially given the needs of precision medicine research.
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