The Use of SS-MIX in Clinical Trials and Postmarketing Studies： From the View of Pharmaceutical Industries
10.3820/jjpe.18.57
- VernacularTitle:7．SS-MIX を治験や製造販売後調査へ利用することについて製薬企業からの見解
- Author:
Kotonari AOKI
;
Yasushi KOMIYAMA
;
Tatsuo KAGIMURA
;
Koji SHOMOTO
;
Takeshi HIRAKAWA
- Publication Type:Journal Article
- Keywords:
data base;
personal information protection;
post-marketing surveillance;
clinical study;
pharmacovigilance
- From:Japanese Journal of Pharmacoepidemiology
2013;18(1):57-64
- CountryJapan
- Language:Japanese
-
Abstract:
Those of us in the pharmaceutical industry are in favor of using SS-MIX standardized storage to alleviate the burden on medical professionals. As previously suggested, in addition to the benefits of reducing study periods, supporting a variety of investigative research and safety measures, and obtaining more accurate data on disease states and treatments, actively using this kind of new technology is a societal imperative in an information-driven society. Possible practical uses include (1) general application in drug use surveillance and special drug use surveillance, (2) appropriate sampling surveys, (3) patient monitoring, (4) observational studies with controls, such as those using disease registries, and (5) reviewing the results of safety measures. However, there is the issue of regulatory interpretation and consensus, with debate on information protection, and the issue of social infrastructure. Therefore, industry, government, and academia must continue its active, cooperative discussion to enable true implementation of this technology. (Jpn J Clin Pharmacoepidemiol 2013; 18(1): 57-64)
