The New Type of Investigations Using Pharmacoepidemiologic Methods in Japan

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Chapter: Pharmacovigilance: Pharmacovigilance and Risk Management in Japan

According to the E2E guidelines, the classic comparative observational studies, including the case–control study, cohort study and cross-sectional study, are essential in the individually designed study to evaluate adverse events.


THE NEW TYPE OF INVESTIGATIONS USING PHARMACOEPIDEMIOLOGIC METHODS IN JAPAN

According to the E2E guidelines, the classic comparative observational studies, including the case–control study, cohort study and cross-sectional study, are essential in the individually designed study to evaluate adverse events. A brief introduction to each type of study is given in the ‘Annex’ of the guideline. In some of the recent investigations conducted in Japan as a ‘DUI of Special Population,’ the standard design in pharmacoepidemiology is used, which is distinct from the old stereotyped ‘DUI.’ For example, a ‘DUI of Special Population’ is being conducted to study the association between gefitinib (a chemother-apeutic agent to treat non-small cell lung cancer) and interstitial lung disease (ILD). In the study, a nested case–control design is employed where all of the patients in participating hospitals are registered if the patient has already been treated by one or more regimens of chemotherapy for non-small cell lung cancer, irrespective of the treatment eventually selected for the patient. When the patient is regis-tered, only a small amount of information, such as gender and age, is collected. A case is defined as an episode of ILD which develops during the 12-week observation period after registration. For each case, four controls are selected from the non-cases who are being followed at that time. From a case and four controls, the detailed information is collected to study the relative risk of the ILD for gefitinib and various other risk factors, including genetic factors such as single nucleotide polymorphisms, which may be asso-ciated with the development of ILD (Fukuoka et al., 2005).

Though not carried out as research under the regu-lation of GPSP, a case–control study on the asso-ciation between non-steroidal inflammatory drugs (NSAIDs) and upper gastrointestinal bleeding (UGIB) has recently been conducted in Japan. This case– control study was conducted to understand the associ-ation between NSAIDs and UGIB before the approval of any Cox-2 inhibitor in Japan. In the study, for each case identified in one of the participating hospitals, two community controls were selected from the popu-lation registry in the district where the case’s home was located by matching gender and age (Kubota et al., 2005).

These two examples suggest that the study using the standard design for pharmacoepidemiology (nested case–control design and classic matched case–control design) is feasible in Japan. These studies may act as a prototype of the PMS studies, fulfilling the standard for the comparative observational studies given in the ICH E2E guidelines. The design for the pharmacoepi-demiology studies may be employed more often in the future PMS in Japan, though the traditional stereo-typed DUI may still prevail for several years to come.

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