Roles of the Data Storage System in Clinical Trials and Observational Cohort Studies
10.3820/jjpe.18.31
- VernacularTitle:3．臨床試験，観察研究におけるデータストレージシステムの活用
- Author:
Shinichiro UEDA
;
Shigeru KAGEYAMA
- Publication Type:Journal Article
- Keywords:
post-approval;
cohort study;
data storage system;
registry of patients;
comparative effectiveness research
- From:Japanese Journal of Pharmacoepidemiology
2013;18(1):31-34
- CountryJapan
- Language:Japanese
-
Abstract:
Appropriate observational studies with sufficient external validity are apparently warranted to assess comparative effectiveness and safety of treatment with approved drugs in real world clinical practice. This kind of study must register patients consecutively without any arbitrariness, assess outcome carefully, (e.g. cardiovascular events) and automatically extract clinical data including results from laboratory tests and prescribed drugs. Clinical trials for the assessment of efficacy of newly developing drugs may also need such patients' registry. Data storage system by SS-MIX may be appropriate for this purpose. (Jpn J Pharmacoepidemiol 2013；18(1)：31-34)
