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

Abstract

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.