Research on the Situation and Implications of the Post-marketing All-case Surveillance Study in Japan — Considerations Based on a Questionnaire Survey

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  • NARUKAWA Mamoru
    北里大学大学院薬学研究科臨床医学（医薬開発学）

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  • 医薬品製造販売後の全例調査の実施状況及び意義に関する調査研究（アンケート調査に基づく考察）

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A questionnaire survey addressed to pharmaceutical companies was conducted to collect information on the situation and implications of so-called “all-case surveillance studies” (post-marketing surveillance studies of all cases the drug was used), which have been conducted in Japan. For nearly 90% of 132 drugs, all-case surveillance studies were conducted for the reason that the number of cases in the pre-market domestic clinical trials was too small. Drugs classified as “antiinfectives for systemic use” and “antineoplastic and immunomodulating agents” accounted for more than 60%. Sample size of the surveillance study was pre-planned in about half of the studies, and the number of the collected cases far exceeded the planned cases in many of the studies. While a large number of responses pointed out “catching all the safety information” as the usefulness of the all-case surveillance study, importance from the viewpoint of risk-minimization such as “providing doctors with necessary information for appropriate use of the drug” and “confirming eligibility of patients in a careful manner” was indicated in some cases. Concerning the operation of the study, a lot of comments called for simplification of the case report form and clarification of the criteria and procedure of ending the study.

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