Clinical Epidemiology Section

Staff

• Section chief:            Chieko Ishiguro
• Senior researcher:     Wataru Mimura
• Researcher:              Mahiro Sazawa
• Researcher:              Taku Chikamochi
• Researcher:              Yoshiyuki Tashiro
• Senior SE:                Tetsuya Nakajima
• SE:                          Kyouichi Takayama
• Secretariat:              Maki Kubo

About us

The Clinical Epidemiology Section carries out research and support activities mainly in the field of pharmacoepidemiology. In particular, we evaluate the effectiveness and safety of drugs and vaccines using large healthcare databases (e.g. claims data, electronic health records, municipal administrative data, etc.).

In recent years, epidemiological studies using such data, rather than data collected under the strict control of traditional clinical trials, have increasingly been used as evidence to support pharmaceutical regulatory decisions. In the pharmaceutical and medical device industries, healthcare databases have often been referred to as "real world data" (RWD) and the evidence derived from these studies as "real world evidence" (RWE).

The analysis of RWD does not always lead to RWE. At the research design stage, the generation of RWE from RWD requires 1) the selection of an appropriate database (with characteristics appropriate to the research purpose and with appropriate quality control), 2) the selection of an epidemiological study design appropriate to the research purpose, 3) the establishment of highly valid algorithms for each element of the study design (target population, exposure, outcome, confounders, etc.), and 4) the selection of appropriate statistical analysis methods. In addition, at the research implementation stage, 5) advanced programming techniques are required to adequately handle large data sets (e.g., sometimes more than a billion rows), and 6) highly transparent implementation standards and procedures are required to avoid arbitrary analysis.

Our section aims to generate RWE using RWD by conducting pharmacoepidemiological studies appropriately and consulting from the perspective of pharmacoepidemiology.

Research

●Vaccine effectiveness/safety monitoring (The VENUS Study)

　・Evaluation of effectiveness and safety using the municipality-based database.

　・Establishment of a post-approval vaccine effectiveness and safety monitoring system in collaboration with the government.

●Pharmacoepidemiological studies using various databases.

　・Evaluation of drug effectiveness and safety using various health insurance databases.

　・Development and validation of algorithms to identify patients with specific diseases from claims data

●Regulatory Science Research

　・Research on promoting RWE's contribution to the regulatory decision-making process

　・Research on the efficiency of the safety-related regulatory decision-making process