TY  - JOUR
PY  - 2020//
TI  - Principles for the use of large-scale medical databases to generate real-world evidence
JO  - Annals of clinical epidemiology
A1  - Kumamaru, HIraku
A1  - Fukuma, Shingo
A1  - Matsui, Hiroki
A1  - Kawasaki, Ryo
A1  - Tokumasu, Hironobu
A1  - Takahashi, Arata
A1  - Hara, Seigo
A1  - Aoki, Kotonari
A1  - Fujita, Takanori
A1  - Miyata, Hiroaki
SP  - 27
EP  - 32
VL  - 2
IS  - 1
N2  - 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>
LA  - en
SN  - 2434-4338
UR  - http://dx.doi.org/
ID  - ref1
ER  -