Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Clin Pharmacol Ther. 2020 Jan;107(1):136-139. doi: 10.1002/cpt.1604. Epub 2019 Sep 13.
"Regulatory science" (RS) has been defined in various ways, but, nevertheless, the definitions of RS in different parts of the world include many common elements. It seems to be a common view that RS is not basic or applied science but, rather, focuses on the estimation and prediction of safety and efficacy. Thus, we think RS overall should incorporate not only RS specifically for medical product assessment but also RS engineering to provide prediction and estimation tools for those purposes, including guideline/guidance development. It is important as well to consider the potential contribution of RS to rational medicine (i.e., to evidence-based medicine in a broader context), and especially to real-world evidence generation. We will look at how definitions of RS have evolved, and how we believe RS might develop in the future. Taking a patient-centric view, we re-emphasize RS is an ethical science contributing to society and human welfare.
“监管科学”（RS）有多种定义，但世界各地的 RS 定义都包含许多共同要素。似乎有一种共识认为，RS 不是基础或应用科学，而是侧重于安全性和有效性的评估和预测。因此，我们认为 RS 总体上不仅应包括专门用于医疗产品评估的 RS，还应包括 RS 工程，以提供用于这些目的的预测和估算工具，包括指南/指导方针的制定。同样重要的是，要考虑 RS 对合理医学（即在更广泛的背景下的循证医学）的潜在贡献，特别是对真实世界证据的产生。我们将研究 RS 的定义是如何演变的，以及我们认为 RS 在未来可能会如何发展。从以患者为中心的角度出发，我们再次强调 RS 是一门有助于社会和人类福祉的伦理科学。
