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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