PE Study Design

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    1. Study design

    To evaluate the causality between a drug and an adverse event, we monitor and observe the case and control groups of a study and we use research designs like cohort (all users of a drug are identified and followed up to determine what events or ADRs occur) and case-control study (all cases of the disease are identified and the use of the drug of interest is compared with controls without the disease).

    의약품-부작용 인과관계규명을 위한 약물역학연구설계
    Intervention Study designs Classification
    (causal relationship)
    Convincing power
    Observational study Case report Descriptive study
    very weak
    Case series study
    Cross-sectional study
    Case-control study Analytic study
    Cohort study
    Randomized clinical trial very strong

    2. Data collection

    To conduct a pharmacoepidemiologic study, we collect data directly or analyze databases such as health insurance claims database, hospital EMR database, and national statistics mortality data.

    1) Collection of data


     We conduct in-depth studies on drug exposure, adverse events, confounding factors, and etc.


     We directly collect data on about adverse events if necessary. Such cases include over-the-counter drugs, drugs  not covered under national health insurance, and adverse events without diagnostic codes


     We also use drug registry data, which contain information on the drug users and adverse events, for causality  assessments.

    2) Analysis using other databases


     Advantages of using other databases include their representativeness of a large population, high validity, and  efficiency.


     We can analyze associations among drug use, cancer risk and death by linking different databases.


     Recently, we conducted pharmacoepidemiological studies using the Common Data Model(CDM). CDM is based on hospital data, and includes laboratory test results and drugs not covered by national health insurance.

    3. Evaluation and Conclusion

    We analyze the data to determine whether the suspected causal drugs actually had an effect on the outcome and generate drug safety information.