@article{ref1,
title="Principles for the use of large-scale medical databases to generate real-world evidence",
journal="Annals of clinical epidemiology",
year="2020",
author="Kumamaru, HIraku and Fukuma, Shingo and Matsui, Hiroki and Kawasaki, Ryo and Tokumasu, Hironobu and Takahashi, Arata and Hara, Seigo and Aoki, Kotonari and Fujita, Takanori and Miyata, Hiroaki",
volume="2",
number="1",
pages="27-32",
abstract="BACKGROUND The development and expanding accessibility of large-scale medical databases supportincreasing use of these databases for clinical epidemiological studies in Japan.   METHODS Members of the Database Utilization Committee of the Society of Clinical Epidemiologydiscussed the ways to enhance scientific rigor in the utilization of large-scale medical data‐bases in Japan. The topics covered included what we need to know about the currentresearch environment when conducting large-scale medical database studies, the key pointsto consider when conducting clinical research using these databases, and the use of real-world evidence in regulatory decision making.   RESULTS In generating real-world evidence, several evaluation principles should be noted: the characteristicsof data commonly used for clinical epidemiology in Japan; the need for reproducibility andtransparency in database studies; the development of research questions for database stud‐ies; the need to assess the quality and validity of data; and legal and ethical considerations.We also introduce the discussions on real-world evidence for drug approval applications.   CONCLUSIONS With rapid technological developments, the characteristics of medical databases and analyti‐cal methods will evolve over time. Keeping these principles in mind, we must continuouslyupdate the evaluation methods and strategies used to assess the data.   KEY WORDS data quality and accuracy, transparency and reproducibility, bid data, Japan, research questions<p /> <p>Language: en</p>",
language="en",
issn="2434-4338",
doi="",
url="http://dx.doi.org/"
}