医薬品の安全性を評価するための臨床検査データの取り扱い : 市販後調査における安全性データの活用

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In our institution, the data management technique used for CRC activities during clinical trials and clinical studies conducted after marketing was introduced into PMS (Post Marketing Surveillance) in October, 1999. Through obtaining the evaluation item, laboratory and adverse drug reaction data needed for surveillance from the site of treatment and recording them as source data, we have been aiming to raise the quality of PMS data We investigated the implementation status of the CRC data management technique in the period from April, 2002 to March, 2004 and discuss the findings in this report. We focused on the strong subjective element in making judgments concerning abnormal changes in laboratory values connected with safety and felt that obtaining a coefficient of variation for each laboratory parameter would enable reference values to be provided, which would lead to more objective judgments. Total bilirubin (TB) had the largest coefficient of variation, followed by BUN, ALT, and AST. Electrolytes such as Na, K, and Cl, had very small coefficients of variation. The utilization of post-marketing clinical laboratory data was also reviewed, through which we found that in the case that no data was available for the time directly before beginning administration, data for a period up to 3 months prior to ad ministration could be used. Doing this enabled the amount of missing measurements to be gradually reduced and the use of available data to be expanded.
日本医療薬学会の論文
2005-01-10

医薬品の安全性を評価するための臨床検査データの取り扱い : 市販後調査における安全性データの活用

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