OM1, Inc, 800 Boylston Street, Suite 1410, Boston, MA, 02199, USA.
Harvard Medical School, Boston, MA, USA.
Ther Innov Regul Sci. 2020 Mar;54(2):303-307. doi: 10.1007/s43441-019-00058-6. Epub 2020 Jan 6.
The use of real-world data and real-world evidence to inform health care decisions is increasing. Yet, the variable quality of these data and the lack of widely-accepted criteria by which to assess quality create uncertainty about how and when to use these data and the associated evidence in decision making. Patient registries are an important source of real-world data and real-world evidence. The good practices and evaluation criteria developed for patient registries are highly relevant to real-world data and real-world evidence and offer a foundation for a unified set of quality criteria that can be applied across sources of real-world data and real-world evidence intended for use in medical product evaluation.
真实世界数据和真实世界证据在医疗决策中的应用正在增加。然而，这些数据的质量参差不齐，缺乏广泛接受的质量评估标准，这使得人们不确定如何以及何时在决策中使用这些数据和相关证据。患者登记处是真实世界数据和真实世界证据的重要来源。为患者登记处制定的良好实践和评估标准与真实世界数据和真实世界证据高度相关，为一套统一的质量标准奠定了基础，这些标准可以应用于用于医疗产品评估的各种真实世界数据和真实世界证据来源。
